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Light Motor
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 1601247-001Model Electric Micromtors
Identity
- Trade Name
- LIGHT MOTOR EUDAMEDFDA UDI
- Generic Name
- Dental surgical power tool motor, electric FDA UDI
- Device Name
- Electric Micromtors EUDAMEDThe ELECTRIC MICROMOTORS transforms an electrical power into mechanical rotation movement, to define speed and torque to a dedicated bur fixed to an adequate contra-angle or straight handpiece for different clinical applications. The micromotor connected to a cable or a hose depending on the type (the hose integrates water and air connection) is driven using an electronic control either integrated in a dental console or a dental unit. FDA UDI
- Model / Reference
- Electric Micromtors EUDAMED1601247-001 EUDAMEDFDA UDI
- Description
- The ELECTRIC MICROMOTORS transforms an electrical power into mechanical rotation movement, to define speed and torque to a dedicated bur fixed to an adequate contra-angle or straight handpiece for different clinical applications. The micromotor connected to a cable or a hose depending on the type (the hose integrates water and air connection) is driven using an electronic control either integrated in a dental console or a dental unit. FDA UDI
Identifiers
- Primary DI / UDI-DI
- J00716012470011 EUDAMEDFDA UDI
- Basic UDI-DI
- ++J007EMOT0001UH EUDAMED
- Direct Marketing DI
- J00716012470011 EUDAMED
- FDA Product Code
- EFB FDA UDI
- EMDN Code
- Z12110199 INSTRUMENTS FOR DENTAL TREATMENT UNITS - OTHER EUDAMED
- GMDN Term
- Dental surgical power tool motor, electric FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 872.4200 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Light Motor by Bien-Air Dental SA — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | ++J007EMOT0001UH | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Bien-Air Dental SA
- EUDAMED SRN
- CH-MF-000014661
- Authorised Representative
- Bien-Air Europe Sàrl FR-AR-000011942
Sources (2)
- EUDAMED a67edf84-2377-40bc-8c13-bed19e988f73 61 fields · synced Jun 20, 2026
- FDA UDI 92079299-9752-4340-9f35-3fe4e3d35449 34 fields · synced May 30, 2026