®

CROWN
Facts and scientific study results

1
 INDICATIONS

Permanent crowns Long-term temporary bridges Denture teeth

TABLE OF CONTENTS Inlays Onlays Veneers

1. Basic information on the material and the manufacturing process 4

TECHNICAL DATA
2. Chewing simulation – Permanent crowns 6
Parameter Standard Unit Results
3. Chewing simulation – Long-term temporary bridges 8 Colors – – A1, A2, A3, B1, B3, C2, D3, BL

4. Marginal-gap tightness 10 Bending fracture DIN EN ISO 104771) MPa 115

5. Abrasion resistance 11 Modulus of elasticity DIN EN ISO 104771) MPa 3500

6. Color uniformity and colorfastness 12 Water absorption DIN EN ISO 104771) µg/mm³ < 40

7. Curing depth 13 Solubility DIN EN ISO 104771) µg/mm³ < 7.5

8. Bond strength with luting cements 14 Shore D hardness Internal method Shore D 90

9. Flexural strength 15
Barcol hardness DIN EN 592) Barcol 54

Viscosity Internal method mPa·s 1750

10. Water absorption and solubility 16
Biocompatibility DIN EN ISO 10993-13) – fulfilled
11. Information on denture teeth/denture manufacture 17
12. Bond strength – denture tooth and denture 18
1)
Crown and veneering resins (following the standard)
2)
Glass-fiber-reinforced resins – Determination of indentation hardness with a Barcol hardness tester
3)
Biological assessment of medical devices – Part 1: Assessment and testing in the context of a risk management system.

13. Biocompatibility 19
Unless otherwise indicated, all tests have been carried out at DETAX GmbH or at SD Mechatronik GmbH in accordance with the relevant standards and
specifications.
The test designs used in the chewing simulations were created by our technology partner Flemming Dental Tec GmbH.

2 3
1. INFORMATION ABOUT THE MATERIAL AND al printers, the cleaning quality with various cleaning

THE MANUFACTURING PROCESS

methods, the surface quality and mechanical stability
during post-exposure by the differing types of post
exposure equipment.

FREEPRINT® CROWN is a light-curing formulation for FREEPRINT® CROWN also allows performing process- Figs. 2 and 3 show two height comparison images of
the generative production of permanent crowns, inlays, ing and post-exposure with other equipment, such as a crown in occlusal and intracoronal view, respectively.
onlays, veneers and denture teeth, as well as long-term parameter-controlled cleaning in a fully automated This is a surface comparison between the surface of
temporary bridges of medical device class IIa using DLP cleaning unit or post-exposure in an LED post-exposure the printed crown recorded by means of an optical laser
3D printing. Optimum adaptation of the material to the unit under vacuum. scanner and the original design file before printing. The
patient is ensured by a wide range of esthetically pleas- height differences are displayed in color, whereby the
ing shades in accordance with the VITA classical A1–D4 The influence of incorrectly performed processing can green color stands for very high accuracy of fit and
shade scheme, which are not affected by environmental be seen in Figure 1. The chalking that occurs, the ex- the red and blue colors for stronger deviations into
influences thanks to low water absorption. In addition posure of pigments on the surface due to loss of the the positive or negative range, respectively. The height
to its perfectly matched transparency and opacity, the organic resin matrix, during the cleaning process, is differences are by default all in a range between -20 µm Fig. 2: Surface comparison: occlusal view

material has optimum dimensional stability thanks to due to too long or aggressive cleaning. In the case of and 30 µm. Larger deviations of more than ±50 µm can
maximum flexural strength and abrasion resistance. imperfectly adjusted formulations, this can be circum- be measured only selectively and cannot be completely
To achieve these excellent characteristics, the max- ruled out in generative manufacturing processes due to
imum achievable quality and patient satisfaction, a the pixel size of the projectors and the layer thickness
completely secured and validated process is necessary. during printing, or due to artifacts during scanning.
That is why it is important to always and without excep-
tion follow the instructions for use during manufacture, Based on these comparison images, it is possible to
processing and finishing. easily and accurately check the building accuracy of
the 3D printers, as well as the quality of the cleaning
The following quick reference guide outlines the se- process.
quence of processing and finishing, which is intended
to serve as the basis for all tests and measurements
performed in this study. For more detailed information
Fig. 1: Comparison of surface conditions after cleaning
on production and finishing, please refer to the instruc-
tions for use. vented only by tedious manual cleaning, e.g. dabbing
Fig. 3: Surface comparison: intracoronal view
with cotton swabs or cloths soaked in isopropanol.
The restorations are printed in a 3D printer according to However, here special attention must be paid to the
the instructions for use and then processed as follows: fit, as this manual cleaning step does not allow easy
After removing the objects from the building plate, they and reproducible removal of the excess resin, which
are first freed from most of the excess resin with a light can lead to fitting problems in hard-to-reach areas that
stream of compressed air before being cleaned in an can be corrected only by subtractive removal of the
ultrasonic bath with isopropanol for one minute. The surface particles. These processes are not automated
support structures are then removed, and the printed and controlled, which is why automated cleaning in CERTIFIED

PROCESS VALIDATION PRINTERS VALIDATED

CERTIFIED VALIDATED BIOCOMPATIBLE
LATEST

objects are once again cleaned of excess resin and an ultrasonic bath or in a cleaning device has distinct
VERSION
RELIABLE WWW.DETAX.COM

385 nm 405 nm

Qualification
Done

support residues using compressed air. Further cleaning advantages.

In process
ASIGA ASIGA ASIGA ASIGA MICROLAY Miicraft Miicraft Miicraft Rapid shape Rapid shape Rapid shape Rapid shape Straumann W2P Flashforge Microlay Moonray Phrozen Prusa Research Shining 3D Shining 3D Sprintray Dentsply Sirona
On request Max / Mini Pico2 PRO2 PRO 4K Versus Prime / Ultra Series Profession / D10 / D20 Series D30 / D40 Series D70 /D90 Series D100 P series Hunter Eve Pro S100 Sonic 4K / XL MEDICAL ONE Accu-Fab D1s Accu-Fab L4D Pro S Primeprint
Hyper Series Advance Series

temp

crown

Q3/22

(one minute) in a separate vessel with isopropanol and

denture

ortho

FREEPRINT®
MED
splint 2.0

supersplint

final drying with compressed air is followed by a drying The processes described here and documented in the
Q3/22

IBT

tray 2.0

tryin

phase for 30 minutes at room temperature. Post-expo- FREEPRINT® CROWN user manual have been carefully
Q2/22

PDF DOWNLOAD
model

model 2.0

FREEPRINT®
model T

sure is performed in a xenon flash unit with 2 × 2000 checked and validated. Tests were conducted to check Validation and

TEC
model WW

gingiva

cast 2.0

flashes in an inert gas atmosphere (nitrogen 4.0). the building accuracy of the material on the individu- compatibility overview
PRIMEPRINT
MED & TEC
Primeprint
(made by
DETAX)

edition: 10.05.22

4 5
2. CHEWING SIMULATION – OBJECTIVE RESULTS
The measurement of the breaking load followed the

PERMANENT CROWNS Permanent crowns are exposed to high stresses during

their wearing periods. Therefore, it is important to de-
All test specimens survived the chewing simula-
tion with thermal load cycling without cracks or
termine whether the printed components can be safely abnormalities. The initial average breaking load
worn by the patient throughout the life cycle of the was 2380 N before the chewing simulation, and the
respective application. For this purpose, it is recom- average breaking load after a load-bearing period
mendable to perform a chewing simulation to test the of ten years was 2180 N. Statistically, however, the
longevity of FREEPRINT® CROWN as a crown material. results before and after the chewing simulation
The aim of the chewing simulation with thermal load cy- are not significantly different, suggesting a barely
cling is to artificially age the permanent crowns in order detectable degradation, which means that material
to mimic the wearing time in the patient’s mouth. In this fatigue can be ruled out.
process, the breaking load of the crowns is determined
before and after the chewing simulation with thermal The measured values are well above the human
load cycling in order to precisely check the behavior of chewing forces, which can reach a maximum value
the material in a typical environment. of approx. 800 N and on average a value of ap-
prox. 500 N. Due to the very good breaking load

METHOD AND MATERIAL

values, it can be assumed that the risk of damage
to the correctly bonded crowns is very low over
this wear period.
The test design used (Fig. 4), consisting of crown and
stump, was designed and produced in an idealized
manner with the following dimensions: The minimum Crowns before Crowns after
chewing simu- chewing simu-
occlusal thickness was 1.5 mm, circularly 1.5 mm and
lation lation
cervically 1.0 mm. Average breaking
load in N 2380 2180

The printed crowns made of FREEPRINT® CROWN Standard deviation

in N 88.6 198
were cemented with the self-adhesive composite luting
cement RelyXTM Unicem 2 by 3MTM onto specially milled
stumps made of the glass-fiber-reinforced high-per- chewing simulation and was carried out in the compres-
formance material Trinia TM
by Bicon Europe Ltd. This sion test (Figure 5). The test specimens were loaded
material was specifically selected because it has an with a universal testing machine and a loading attach-
elastic modulus of 18.8 GPa , equal to that of natural
1
ment with steel ball (diameter: 5 mm) until fracture at
dentin. A steatite ball (diameter: 6 mm) served as an- a loading rate of 1 mm/min, and the results were com-
tagonist in the chewing simulation, which periodically pared with the initial values without chewing simulation.
impinged onto the occlusal surface of the crown with
a force of 50 N, thus simulating chewing. In addition, µCT analysis of the test specimens before
and after the chewing simulation was performed to
Here the thermal load cycling between 5 °C and 55 °C detect any defects (cracks, inclusions, bubbles) caused
reflects the temperature fluctuations in the oral cavity by the printing process or the chewing simulation.
caused by eating and drinking. During the chewing Special attention should also be paid to cementation
Fig. 4 and 5: simulation, the permanent crowns were loaded with (see Chapter 4).
Test specimens and test 2.5 million cycles, corresponding to a simulation of
setup of the chewing
simulation for permanent 10 years of wear.
crowns

1
TDS Trinia (https://www.bicon.com/downloads/pdf/TRINIA_Brochure_DE.pdf)
7
3. CHEWING SIMULATION – OBJECTIVE RESULTS
LONG-TERM TEMPORARY BRIDGES Similar to the requirements for a crown, bridges are also
exposed to high forces and special loads during their
All the test specimens survived the chewing sim-
ulation over one year of wearing without cracks
service life. The force that a bridge must withstand, or abnormalities. The initial average breaking load
especially at the free pontics, is very high. This force was 931 N before the chewing simulation, and
must be deflected via the connectors to the bridge the average breaking load after a wearing period
abutments, which require sufficiently stable connection of one year was 842 N. Statistically, however, the
cross sections for this purpose. results before and after the chewing simulation
are not significantly different.
In order to be able to assess and map these forces
more precisely, once more a chewing simulation is Accordingly, the degradation of the breaking load
suitable. Due to the high forces involved, it was decided by the chewing simulation is not significant, which
to test the application of the three-unit bridge with one means that material fatigue can be ruled out. In
pontic only as a long-term temporary restoration with this measurement, too, the measured values are
a wearing time of one year. also significantly above the values of human chew-
ing forces.

METHOD AND MATERIAL Bridges before Bridges after

chewing simu- chewing simu-
The chewing simulation with thermal load cycling of lation lation
Average breaking
the long-term temporary bridge was performed in a way load in N 931 842
similar to the chewing simulation of the crowns (see
Standard deviation
Chapter 2). The test design used (Fig. 8), consisting of a in N 145 169
three-unit bridge with one pontic and double stump, was
designed and produced in an idealized manner with the
following dimensions: The minimum occlusal thickness In addition, a µCT analysis of the test specimens before
was 1.5 mm, circularly 1.5 mm and cervically 1.0 mm. and after the chewing simulation was performed here,
too, in order to identify any defects (see Chapter 4).
The connection cross-sections of the connectors of the
pontic of the bridge were 16 mm². During the chewing
simulation with thermal load cycling, the bridges were
loaded with 250,000 cycles each, corresponding to a
simulation of slightly more than one year of wear.

The measurement of the breaking load followed the

chewing simulation and was carried out in a com-
pression test comparable to the measurement of the
crowns. The bridges were loaded to failure on the cen-
tral pontic at a loading rate of 1 mm/min.

The results were compared with the baseline values

without chewing simulation in order to exclude possible
degradation. Fig. 8: Test specimen geometry for the chewing simulation

Fig. 6 and 7: Experimental setup of the chewing simulation for long-term temporary bridges

9
4. MARGINAL-GAP TIGHTNESS 5. ABRASION RESISTANCE

OBJECTIVE RESULTS OBJECTIVE RESULTS

A restoration must blend smoothly into the tooth stump No abnormalities were found in the µCT analy- Abrasion resistance is an important property for a crown During the measurement, the height loss of the
without any marginal gap. The marginal gap is a criti- ses on the permanent crowns and the long-term and bridge material, especially for long-term use in the individual specimens was measured and recorded,
cal point that occurs due to the technically inevitable temporary bridges. No cracks or inclusions, such patient’s mouth. FREEPRINT® CROWN comprises spe- resulting in the wear curves of the test specimens.
inaccuracy in the fit between the tooth and the resto- as bubbles, could be detected either before or cial fillers that reduce abrasion and thus counteract the The height loss of the individual test specimens
ration and forms a site of attack for bacteria, which especially after the respective chewing simula- wear of the restorations. In the abrasion resistance test, is shown in the table. It can be seen that there
can then cause tooth decay again (secondary caries). tion. Of particular interest in this examination was lateral movement performed in addition to the vertical are differences between the individual production
With a perfectly adjusted material/printer combination, the cementation between the restoration and the chewing simulation acts on the crowns, exerting more techniques of the crowns, with the fabricated
the production of restorations using the generative stump (Figure 9). This can be seen as a uniform stress on the surface of the crowns and thus possibly teeth in particular attracting negative attention.
process is so accurate that the marginal gap is very layer in the images taken, which suggests that the eroding particles from the surface. It should be noted that FREEPRINT® CROWN,
small. µCT analysis can be used to monitor whether cementation was perfect. with these low height loss values, can be used
the marginal gap changes during artificial aging. As al-
METHOD AND MATERIAL
to produce very stable and abrasion-resistant
ready mentioned for the chewing simulation, the printed restorations, some of which have significantly
objects are also checked for defects before and after higher abrasion resistance than the other ma-
the chewing simulation, such as cracks or inclusions. For determination of the abrasion resistance, various terials tested have, thus enabling production of
crowns were produced and appropriately cemented in long-lasting restorations.
a fixture, and then encapsulated with PMMA. The ma-
METHOD AND MATERIAL terials used for testing consisted of the FREEPRINT®
CROWN, two other generatively processed materials, Test specimen Height loss in mm

To analyze the printed restorations bonded to the two subtractively processed materials, and one fabricat- 1 0.32
Figure 9: µCT image of the cemented bridge after chewing
stumps, the test specimens were irradiated with X-rays, simulation ed material. A steel cone (30° tip angle, tip radius R1), 2 0.46
and the attenuation upon passage through the test which periodically impinges on the occlusal surface of 3 0.72
specimen was recorded. The test specimens were the crown with a vertical force of 50 N, served as the 4 0.39
gradually rotated, and the individual sectional images antagonist for the measurement. The lateral path of 5 0.62
were reassembled to form a solid model. 1.5 mm was traversed at a lateral velocity of 20 mm/s.
6 1.14
During the test, the crowns were loaded with 1.2 million
cycles at a temperature
Chewing cycles
of 37 °C, which corre- 0 240,000 480,000 720,000 960,000 1,200,000
0
Figure 10: µCT image (sectional view) of the cemented sponds to a simulation
bridge after the chewing simulation
of 5 years of wear. -0.2
FREEPRINT® CROWN

-0.4 printed tooth

Wear in mm
printed tooth
-0.6
milled tooth

-0.8 milled tooth

fabricated tooth
-1

Fig. 11: Comparative µCT image (sectional view) of a cemented crown before (left) and after (right) the chewing simulation -1.2

10 11
6. COLOR UNIFORMITY AND COLORFASTNESS 7. CURING DEPTH

OBJECTIVE RESULTS OBJECTIVE RESULTS

FREEPRINT® CROWN, as a permanent or long-term No color changes could be detected upon inspec- For perfect biocompatibility and in order to achieve Measurement of the exposed side showed an
temporary material, has an attractive and suitable tion of the test specimens. Neither the color uni- the outstanding properties of a permanent crown ma- average value of 23.50 HV 0.5 in the Vickers hard-
color for every patient, which does not change due to formity test of the individual batches of the same terial, it is absolutely essential for the material to have ness test. For the side not exposed directly, an
environmental influences either. The material is cur- color nor the colorfastness test of three different sufficient curing depth. Here it is important to perfect- average hardness of 20.31 HV 0.5 could be deter-
rently available in eight colors: A1, A2, A3, B1, B3, C2, colors showed any differences in color. ly adjust the natural appearance of the teeth, i.e. the mined. The ratios of the measured values of the
D3 and BL, based on the Vita classical A1–D4 color relationship between color, opacity and transparency, Vickers hardness test were all well above the limit
scheme (Figure 12). To this end, FREEPRINT CROWN ®
as well as translucency. Measurement of the curing of 70 % mandated by the standard, on average:
was tested for color uniformity, two batches of the depth according to section 5.2 of the standard DIN EN 86.4 %. This ensures that the FREEPRINT ®
same color, and for colorfastness, three different col- ISO 10477:2020 was carried out by means of a Vickers CROWN material is sufficiently cured, and com-
ors, in accordance with sections 5.8 and 5.9 of the hardness test in the HV 0.5 method according to the plete residual polymerization takes place during
DIN EN ISO 10477:2020 standard, as specified in specification of DIN EN ISO 6507:2018. This allows post-exposure. Especially since the temporaries
ISO 7491:2000. determining whether sufficient light can penetrate and, are flipped during post exposure, or post-exposed
more importantly, whether the light used can penetrate from all sides, respectively.
deep enough into the pre-polymerized material during
METHOD AND MATERIAL the post-exposure process to ensure the necessary Curing depth
complete curing during the residual polymerization of
The test specimens used complied with the standard, the objects.
having a height of 1 mm and a diameter of 15 mm, and
were preconditioned and stored in accordance with the 70 %
specifications after polishing to a high gloss. Several METHOD AND MATERIAL
sets of specimens were formed from the various ma-
terials of differing colors: For this purpose, three circular test specimens with a
height of 1 mm and a diameter of 15 mm each were
Set 1 (reference): dark, dry, (23 ± 2) °C, 7 d printed, cleaned and exposed from only one side accord-
Set 2 (water): dark, dist. water, (37 ± 1) °C, 7 d ing to the standard. The top side was facing the light
Set 3 (irradiation): source; the bottom side was facing away from the light
1) dark, dry, (37 ± 1) °C, 24 h source. To comply with the standard, the opposite side
2) irradiation: half covered with aluminum foil, dist. (bottom side) must have at least 70 % of the hardness 0
water, (37 ± 1) °C, 24 h of the facing side (top side). 1 2 3 Ø

3) dark, dry, (37 ± 1) °C, 5 d Measurements according to DIN EN ISO 10477

with minimum value
Three measurements were made on each of three test
The colors FREEPRINT CROWN A1, A2 and A3 were
®
specimens, and the mean values were calculated.
used and submitted to visual testing after seven days.
Storage and external influences must not cause the Fig. 12: Currently available tooth shades
color to deviate from that of the reference specimens.

12 13
8. BOND STRENGTH WITH LUTING CEMENTS 9. FLEXURAL STRENGTH

OBJECTIVE RESULTS OBJECTIVE RESULTS

Determination of the bond strength between All test specimens of both cements met the Determination of flexural strength is one of the classic FREEPRINT ® CROWN achieves values in the
FREEPRINT CROWN and a dental luting cement is
®
specifications of a bond strength of more than mechanical tests for resins and composites. Here, range of 110 MPa to 120 MPa with an elastic
an important test for the selection of the latter when 5 MPa according to the standard. The average essential bending and fracture characteristics are de- modulus of 3400 MPa to 3700 MPa and is thus
bonding the restorations. bond strength of FREEPRINT CROWN to RelyX
® TM termined, which allows statements to be made about well above the specification of the standard, which
Unicem 2 by 3M TM
was 22.1 MPa, and to Variolink ® the maximum bending stress and the elastic modulus defines a minimum requirement of > 50 MPa.
This is a question not only of the adhesive effect Esthetic DC by Ivoclar 21.4 MPa. Both cements of a material. The test was carried out for FREEPRINT ®

between the materials, but also of the margin- are suitable for luting FREEPRINT CROWN res-
® CROWN according to section 5.4 of the standard Flexural strength in MPa
al-gap tightness mentioned in Chapter 4. The bond torations and are listed in the Instructions for Use. DIN EN ISO 10477:2020.
strength between FREEPRINT® CROWN and two lut-
100
ing cements was tested according to section 5.5 of
METHOD AND MATERIAL
3M RelyX Ivoclar
DIN EN ISO 10477:2020. Unicem 2 Automix Variolink Esthetic DC
Bond Bond
Test spec- Test spec-
strength in strength in
imen imen The test specimens to be used (dimension:
METHOD AND MATERIAL
MPa MPa

FREEPRINT® CROWN
1 23.1 1 24.7
2 × 2 × 25 mm) were produced directly on a suit-
able printer and processed and post-exposed ac-
2 21.0 2 24.0
50
To this end, the two cements Variolink Esthetic DC
®
cording to instructions. Conditioning consisted of
3 19.7 3 15.8
by Ivoclar and RelyXTM Unicem 2 by 3MTM were tested water immersion for 24 hours at 37 °C to simu-
4 23.7 4 19.4

COMPETITOR

COMPETITOR
in combination with printed test specimens made of late the environment characterizing the oral cavity.
5 23.0 5 23.0
FREEPRINT CROWN. The cements were applied to the
®
Subsequently, the test specimens are loaded to failure
Ø 22.1 Ø 21.4
printed test specimens in a cylindrical geometry, and in a quasi-stationary three-point bending test at a cross-
light-cured according to the manufacturer’s instructions head speed of 1 mm/min and a gap width of 20 mm
(Fig. 13). Conditioning was performed according to the (Figure 14). The measured force is converted into the 0
standard: Dry storage of test specimens for 24 hours at corresponding flexural strength via the cross-section 1 2 3
(23 ± 2) °C followed by artificial aging in a water bath of the test specimens.
with thermal load cycling between 5 °C and 55 °C for
5000 cycles. The test specimens were loaded to failure
in the following shear test using a universal testing
machine at a constant crosshead speed of 1 mm/min.

The bond strength was determined from the measured

forces and the bonding area, and the test is considered
passed if the bond strength is not less than 5 MPa.

Fig. 13: Test specimen for determination of bond strength

Fig. 14: Determination of the flexural strength

14 15
10. WATER ABSORPTION 11. INFORMATION DENTURE TEETH/
AND SOLUBILITY DENTURE MANUFACTURE
OBJECTIVE RESULTS Production of a complete denture is a time-consuming
and complicated process when using the classical pro-
Minimum water absorption and solubility is an import- The average measured values for the water ab- duction method with powder/monomer mixtures. With
ant basis for the permanent application of FREEPRINT ®
sorption of FREEPRINT CROWN are in the range
® the denture tooth application of FREEPRINT® CROWN,
CROWN. The examination, carried out in accordance from 14 µg/mm³ to 16 µg/mm³ and thus well the dental technician now has the possibility to plan
with section 5.6 and 5.7 of the DIN EN ISO 10477:2020 below the standard specification of < 40 µg/mm³. and manufacture a denture completely digitally, which
standard, provides important findings with regard to It can be assumed that this low water absorp- has a great savings potential in terms of manufacturing
oral stability. Conclusions can be drawn about the ten- tion also exerts significantly positive effects on time. In the manufacture of the denture, it is particularly
dency to discoloration via water absorption, and about the tendency to discoloration, so that no severe important to ensure that the materials used are not
structural integrity and biocompatibility via solubility. discoloration of the objects should be evident in post-exposed after the printing and cleaning process,
the everyday life of the restorations. This has an but remain in their green state.
impact on the esthetics and color stability of the
METHOD AND MATERIAL
Fig. 15: Application of the liquid FREEPRINT® DENTURE material
incorporated restorations, which thus retain the The green state describes the state of a printed object into the cavities under yellow light

desired colors for longer. between printing and post-exposure in which polym-
For the examination, the test specimens having a height erization is not completely finished yet and functional
of 1 mm and diameter of 15 mm each were produced The resulting solubility values for FREEPRINT ® groups are still present on the surface for further reac-
according to the standard, polished to high gloss and CROWN range from 0.1 µg/mm³ to 0.4 µg/mm³ tion. This means that bonding can be carried out using
dried in a desiccator at 37 °C to constant weight. The and are thus also well below the standard speci- the liquid FREEPRINT® DENTURE material without
weight of each test specimen is recorded, and the fication, here < 7.5 µg/mm³. These excellent solu- further chemicals, such as primers or bonders, being
specimens are stored in a water bath at 37 °C for one bility values are an important indication that only required. In addition, it is possible to model the papillae
week. The second weight determination of the test a very small proportion of substances are leached and the transition to the denture teeth when bonding
specimens follows. Subsequently, the test specimens from the restorations, which could potentially have with the liquid material, which leads to further stabili-
were dried again to constant weight and balanced. The a negative impact on the structural integrity of the zation of the bond (Figs. 15–17).
calculated differences from the measured masses of material and its biocompatibility.
the individual test specimens were then related to the For more detailed manufacturing information, please
volumes of the test specimens in order to determine refer to the instructions for use. The high green strength Fig. 16: Insertion of the denture teeth and filling of possible flaws

water absorption and solubility. of the two materials, FREEPRINT ® CROWN and
DENTURE, makes this step possible, since thanks
to the high strength in this state the distortion of the
printed objects is very minimal. Production of the den-
ture teeth as a complete dental arch supports and sim-
plifies the entire process, as the two parts match each
other optimally and thus no fitting problems can occur.

Fig. 17: Removal of the excess with a brush

16 17
12. BOND STRENGTH –
13. BIOCOMPATIBILITY
DENTURE TOOTH AND PROSTHESIS
For a material for crowns and bridges intended for long- In accordance with the MDR, not only freshly produced
OBJECTIVE RESULTS term use in the mouth, accordingly various biocompat- batches of material were used for printing the test spec-
ibility tests must be carried out pursuant to the DIN EN imens and all the tests, but also aged, repeatedly used
For the application as denture teeth, it is important to The bond strength of the measured test speci- ISO 10933-1:2020 standard, which is fundamental for and artificially stressed batches were, in order to ensure
investigate the suitable connection between the ma- mens averaged 40.6 MPa. The resulting fractures determining the biocompatibility of medical devices. stability of the formulation even during and after natural
terials used, FREEPRINT CROWN and FREEPRINT
® ®
could be ascribed to a cohesive fracture within the The indication of FREEPRINT CROWN clearly defines
®
use in production.
DENTURE as denture base material. For this purpose, denture base material. More specifically, the bond according to the standard that it is a medical device
the bonding between the two materials was examined, between FREEPRINT CROWN and FREEPRINT
® ® with a contact duration of more than 30 days (long-term The various printing systems and post-exposure devic-
which was conclusively tested in a shear test according DENTURE, bonded with the liquid FREEPRINT ® contact), which has contact with the mucosa and must es validated for FREEPRINT® CROWN have also been
to section 5.5 of DIN EN ISO 10477:2020. DENTURE, was capable of tearing portions out be tested accordingly. appropriately reviewed to offer customers the widest
of the base plate. The bond between the denture possible variety of systems and process reliability.
tooth and the denture shows a high bond strength. The evaluation begins with a chemical analysis to
METHOD AND MATERIAL identify the substances that can potentially be elut-
ed from the objects, in order to have a toxicologist
Printed cylinders made of FREEPRINT CROWN with
®
evaluate what testing is needed for the material.
a height of 2.5 mm and a diameter of 5 mm each were Test specimen Bond strength in MPa
used as test specimens, which were glued onto likewise
1 43.3
printed platelets made of FREEPRINT® DENTURE.
2 51.7
Liquid FREEPRINT® DENTURE served as the bonding
agent. Conditioning was performed according to the 3 46.9 Biocompatibility tests have been performed
standard: Dry storage of test specimens for 24 hours for FREEPRINT® CROWN in accordance with
4 29.2
the relevant standards.
at (23 ± 2) °C and artificial aging in a water bath with Acute systemic
5 31.7 toxicity for determination
thermal load cycling between 5 °C and 55 °C for 5000
Ø 40.6 of toxicity
cycles. The test specimens were then placed in a uni- (ISO 10993-11)
versal testing machine and loaded to failure with con-
Cytotoxicity for Sensitization for
tact on the cylinders at
determination of cell determination of
a constant crosshead toxicity contact sensitization
speed of 1 mm/min. (ISO 10993-5) (ISO 10993-10)

The fracture pattern

was analyzed for the Chemical
analysis
type of fracture (cohe-
sive or adhesive), and Genotoxicity
the bond strength was Irritation for the for determination
determination of the of the mutation potential
determined from the
irritation potential of genes or
measured forces. (ISO 10993-10) chromosomes
(ISO 10993-3)

Fig. 18: Test set-up for measuring the bond strength between denture and denture tooth

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