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Mono Rapid Grinder FG
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref AL848.314.025Model 16670
Identity
- Trade Name
- Mono Rapid Grinder FG EUDAMEDEDENTA FDA UDI
- Generic Name
- Diamond dental bur, reusable FDA UDI
- Device Name
- Diamant Instrumente EUDAMEDMono Rapid Grinder FG FDA UDI
- Model / Reference
- 16670 EUDAMEDAL848.314.025 EUDAMEDFDA UDI
- Description
- Mono Rapid Grinder FG FDA UDI
Identifiers
- Primary DI / UDI-DI
- E312AL8483140251 EUDAMEDFDA UDI
- Basic UDI-DI
- ++E31216670EL EUDAMED
- Unit of Use DI
- E312AL848314025101 EUDAMED
- FDA Product Code
- DZP FDA UDI
- EMDN Code
- Z12110102 DENTAL DRILLS EUDAMED
- GMDN Term
- Diamond dental bur, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 872.4535 FDA UDI
- Market of Registration
- Liechtenstein 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
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Mono Rapid Grinder FG by Edenta Etablissement — 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 | ++E31216670EL | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Edenta Etablissement
- EUDAMED SRN
- LI-MF-000011937
Sources (2)
- EUDAMED 711af2ab-3f94-4afa-9484-d31b657ef1cf 61 fields · synced Jun 19, 2026
- FDA UDI 56c55a34-1ab4-4780-9593-8413a8d90e7b 33 fields · synced May 30, 2026