Republic of Colombia

Ministry of Health and Social Protection

National Institute for Food and Drug Surveillance - INVIMA

RESOLUCIÓN No. 2018033029 DE 31 de Julio de 2018

By which a Sanitary Registration is granted
The Technical Director of Medical Devices and other Technologies of the National Institute for Drug Surveillance and
Alimentos INVIMA, en ejercicio de las facultades Legales conferidas en el Decreto 2078 de 2012, decreto
Regulatory 4725 of 2005, law 1437 of 2011 and law 962 of 2005

CONSIDERING

THEREFORE, THIS INSTITUTE HAS REQUESTED THE GRANTING OF AN AUTOMATIC HEALTH REGISTRATION BASED ON THE
VERIFICATION OF THE TECHNICAL LEGAL DOCUMENTATION SUBMITTED TO THE DIRECTORATE OF MEDICAL DEVICES AND OTHERS
TECHNOLOGIES, ISSUING A FAVORABLE CONCEPT FOR THE ISSUANCE OF THIS SANITARY REGISTRATION.
AS A RESULT OF THE ABOVE, IN ACCORDANCE WITH ARTICLE 57 OF LAW 962 OF 2005, INVIMA WILL CARRY OUT THE
CHECK POSTERIOR WITHIN FIFTEEN (15) DAYS FOLLOWING ITS ISSUANCE.

SOLVE

ARTICLE ONE.- GRANT SANITARY REGISTRATION FOR A TERM OF TEN (10) YEARS TO
PRODUCTO: LOW ROTATION PRECISION INSTRUMENTS
BRAND: W&H
SANITARY REGISTRATION NO.: INVIMA 2018DM-0018349
TYPE OF RECORD: IMPORT AND SELL
TITULAR(ES): EURODENT REPRESENTATIONS S.A.S WITH ADDRESS IN BOGOTA - D.C.
MANUFACTURER(S): W&H DENTALWERK BURMOOS GMBH WITH DOMICILE IN AUSTRIA
IMPORTADOR(ES): REPRESENTACIONES EURODENT S.A.S WITH ADDRESS IN BOGOTA - D.C.
ACONDICIONADOR(ES): REPRESENTACIONES EURODENT S.A.S WITH ADDRESS IN BOGOTA - D.C.
TYPE OF DEVICE INVASIVE
RISK: IIA
COMPOSITION:
PARTS THAT MAKE UP THE MEDICAL DEVICE
HANDPIECE: HANDPIECE TIP, RING FOR THE HOLDING SYSTEM, COVER
TOP OF STRAWBERRIES, SCREW PASSER.
ANGLE CONTRA: PRESS BUTTON, SPRAY NOZZLES, COMPACT GLASS ROD,
GRAB PROFILE, ADJUSTABLE TAB, NOZZLE CLEANER.

AIR MOTORS: ISO3964 CONNECTION, 2(3)WAY BORDEN CONNECTION, 4 STANDARD 6 WAYS

STANDARD PIPES, O-RING, SPEED REGULATING RING, HOLDER COVER
MOTOR COVER, LED RING, ELECTRICAL CONTACTS, EXTERNAL COOLANT PIPE

USES: DENTAL TREATMENT IN PATIENT FOR REMOVAL OF CARIES MATERIAL

PREPARATION OF CROWNS, FINISHING AND POLISHING OF DENTAL SURFACES
COMMERCIAL PRESENTATION: PER UNIT
OBSERVATIONS: THE PRESENT HEALTH REGISTER COVERS THE FOLLOWING REFERENCES:

Contra angle
30009 WG-56 LT Contra-angle
30010 WG-56 A Contra-angle
30011 WG-66 LT Contra-angle
30012 WG-66 A Contra-angle
30024 WK-93 LT Contra-angle
30025 WK-56 LT contra-angle
30026 WK-66 LT Contra-angle
30027 WK-86 LT Contra-angle
30013 HG-43A HANDPIECE
30028 HK-43 LT HANDPIECE
30084 WG-67 LT contra-angle
30085 WG-67 A contra-angle
30076 WG-69 LT Contra-angle
30077 WG-69 A Contra-angle
Alegra contra-angle
10255600 WE-56 LED G Contra-angle
10256600 WE-66 LED G Contra-angle
10256601 WE-66 A Contra-angle
 Republic of Colombia
Ministry of Health and Social Protection
National Institute for Food and Drug Monitoring - INVIMA

RESOLUTION No. 2018033029 OF July 31, 2018

By which a Sanitary Registration is granted
The Technical Director of Medical Devices and other Technologies of the National Institute for Drug Surveillance and
INVIMA Foods, in the exercise of the legal powers granted in Decree 2078 of 2012, decree
Regulatory 4725 of 2005, Law 1437 of 2011 and Law 962 of 2005

Contra-angle for endodontics

10217302 WD-73M Contra-angle
10217402 WD-74M Contra-angle
12227501 EB-75 Contra-angle
12227901 EB-79 Contra-angle
12226201 EB-62 Contra-angle

ENTRANCE
12923000 EB-300 ENTRAN COMPLETE
COMPOSED OF:
12820300 EB-3H HANDPIECE PROPULSIVE
ANTI-HELMET
12321601 EB-16
ANGLE
05338300 CHARGER
05451300 LI-ION 3.7 BATTERY
Contra-angle and handpiece for prophylaxis
10114403 HP-44 M HAND PIECE
10216403 WP-64 M Angle Contrar
10216443 WP-64 MU ANGLE CONTRA
SURGERY AGAINST ANGLES AND HANDPIECE
10207550 WI-75 E/KM ANGLE CONTRA
30032 WS-75 L G Contra-angle
30038 WS-56 Contra-angle
30039 WS-56 L G Angle contra
30041 WS-92 Contra-angle
30042 WS-92 L G Contra-angle
30047 WS-91 contra-angle
30048 WS-91 L G Contra-angle
30053 S-9 HANDPIECE
30054 S-9 L G HANDPIECE
30056 S-11 handpiece
30057 S-11 L G Handpiece
30059 S-10 HAND PIECE
30060 S-15 HANDPIECE
30061 S-12 HANDPIECE
SAW HANDPIECE
10100801 S-8R SAW HANDPIECE
10100802 S-8O SAW HANDPIECE
10100803 S-8S HANDPIECE SAW

ADAPTERS AND COUPLINGS

02039900 BORDEN 2-L SET COUPLING ADAPTER

02083500 MIDWEST - BOARD-3L COUPLING ADAPTER KPL

02752500 RM-6L>5L COUPLING ADAPTER KPL

 Republic of Colombia
Ministry of Health and Social Protection
National Institute of Food and Drug Surveillance - INVIMA

RESOLUCIÓN No. 2018033029 DE 31 de Julio de 2018

By which a Sanitary Registration is granted
The Technical Director of Medical Devices and other Technologies of the National Institute for Medicine Surveillance and
Food INVIMA, in exercising the legal powers granted in Decree 2078 of 2012, decree
Regulatory 4725 of 2005, law 1437 of 2011 and law 962 of 2005

TABLE TOP CONTROL.

10531600 EM-E6 TP CPL Control Unit
TO COPE WITH:
06339800 EM-E6 TP TABLE TOP BASIC
10532000 EA-2D SCREEN
06047801 VE-6 CONNECTING HOSE
DENTAL ELECTRIC MOTOR CONTROL
06845100 EM-C2 LED CONTROL WITH
10530601 EM-E6 DENTAL ELECTRIC MOTOR
06047601 VE-6 HOSE
ALTERNATIVE:
06047801 VE-6 Hose
ALTERNATIVE:
10530700 EM-E7 LED DENTAL ELECTRIC MOTOR
04636700 VE-9 HOSE
ALTERNATIVE:
05343701 VE-9 Hose
04109100 VE-9 Hose
10532000 EA-2 D SCREEN

06851800 EM-C3 CONTROL CON:

10530601 EM-E6 DENTAL ELECTRIC MOTOR
06047601 VE6 HOSE
ALTERNATIVE:
06047801 VE-6 HOSE
ALTERNATIVE:
06286500 EM-LED LED ELECTRONIC
10530700 EM-E7 LED DENTAL ELECTRIC MOTOR
ALTERNATIVE:
10530800 EM-E8 LED DENTAL ELECTRIC MOTOR
04636700 VE-9 HOSE
ALTERNATIVE:
05343701 VE-9 HOSE
04109100 VE-9 HOSE

contra angle, handpieces

30216 WK-93 LT S contra-angle
30217 WK-56 LT S Angle Attachment
30218 WK-66 LT S Contra-angle
30116 WE-56 Contra-angle
30117 WE-57 Contra-angle
30118 WE-66 Contra-angle
30120 WE-56T ANGLED CONTRA
30121 WE-57 T Contra-angle
30122 WE-66T contra-angle
30119 HE-43 HANDPIECE
 Republic of Colombia
Ministry of Health and Social Protection
National Institute of Food and Drug Surveillance - INVIMA

RESOLUCIÓN No. 2018033029 DE 31 de Julio de 2018

By which a Sanitary Registration is granted
The Technical Director of Medical Devices and other Technologies of the National Institute of Drug Monitoring and
Food INVIMA, in exercise of the legal powers granted in Decree 2078 of 2012, decree
Regulatory 4725 of 2005, law 1437 of 2011 and law 962 of 2005

30123 HE43 T HANDPIECE

AIR ENGINES
30102 AM-25 L RM AIR ENGINE
30103 AM-25 A RM AIR MOTOR
30104 AM-25 A BC AIR MOTOR
30105 AM-25 E RM AIR ENGINE
30106 AM-20 RM AIR MOTOR
30107 AM-20 and RM AIR ENGINE
30108 AM-25 RM AIR MOTOR
30109 AM-20 E BC AIR MOTOR
30111 AM-25 E BC AIR MOTOR
30112 AM-25 BC AIR MOTOR
30113 AM-20 BC AIR MOTOR

CONTROLS, HAND PIECES, ANGLES

30242 AF-100 CPL Control Unit

30241 MF-100 CPL CONTROL UNIT

30178 EM-12L DENTAL ELECTRIC MOTOR

30182 MC-2.0 E CONTROL
30180 VE-10 HOSE

30058 S-11L HANDPIECE

30040 WS-56L Contra Angle
30033 WS-75L Contra angle
30049 WS-91L contra angle
30043 WS-92L Contra angle

PROSTHETIC SCREWDRIVER
PROSTHETIC SCREWDRIVER
16934000 IA-400
CPL
16338001 IA-80 contra-angle
HANDPIECE OF
16834000 IA-40H
DRIVE
05338301 IA-400 CHARGING STATION

INCLUDES ACCESSORIES, SPARE PARTS, AND CONSUMABLES

LIFETIME: Handpieces and contra-angles 7 years, contra-angles for endodontics 7 years,
PROPHYLAXIS CONTRA ANGLES 7 YEARS, SURGICAL CONTRA ANGLES 7 YEARS, S SERIES -
8 to 10 years, adapters and couplings 7 years, electric dental motor control 5
YEARS, AIR ENGINES 7 YEARS.
FILE NO.: 20148419
CASE NUMBER: 20181149140
DATE OF FILING: 26 07 2018

SECOND ARTICLE.-ONLY THE RECOURSE OF REPOSITION PROCEEDS AGAINST THIS RESOLUTION, WHICH MUST
INTERPOSE BEFORE THE DIRECTOR OF MEDICAL DEVICES AND OTHER TECHNOLOGIES, WITHIN TEN (10) DAYS
FOLLOWING YOUR NOTIFICATION, UNDER THE TERMS STATED IN THE ADMINISTRATIVE PROCEDURE CODE AND OF THE
Administrative Litigation.
 Republic of Colombia
Ministry of Health and Social Protection
National Institute of Food and Drug Surveillance - INVIMA

RESOLUCIÓN No. 2018033029 DE 31 de Julio de 2018

By which a Sanitary Registration is granted
The Technical Director of Medical Devices and other Technologies of the National Institute of Medicine Surveillance and
Food INVIMA, in exercise of the legal powers conferred by Decree 2078 of 2012, decree
Regulatory 4725 of 2005, Law 1437 of 2011 and Law 962 of 2005

ARTICLE THREE.- THIS RESOLUTION TAKES EFFECT FROM THE DATE OF ISSUANCE.

ARTICLE FOURTH.- THE RIGHTS DERIVED FROM THIS RESOLUTION SHALL BE SUBJECT TO POSTERIOR CONTROL THAT
THE NATIONAL INSTITUTE OF MEDICINE AND FOOD VIGILANCE INVIMA MUST CARRY OUT IN ACCORDANCE WITH WHAT
CONTEMPLATED BY ARTICLE 22 OF DECREE 4725 OF 2005.

COMMUNICATE, NOTIFY AND COMPLY

GIVEN IN BOGOTÁ D.C. ON JULY 31, 2018

THIS SPACE, UNTIL SIGNED, IS CONSIDERED BLANK.

ELKIN HERNAN OTALVARO CIFUENTES

TECHNICAL DIRECTOR OF MEDICAL DEVICES AND OTHER TECHNOLOGIES
Proyecto: Legal: jmarinc, Técnico: msandovalc, Revisó: cordina_varios