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Bohrer für Pin und Head Master
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 6325-3Model 16202
Identity
- Trade Name
- Bohrer für Pin und Head Master EUDAMEDEDENTA FDA UDI
- Generic Name
- Pin/post dental drill bit FDA UDI
- Device Name
- Wurzelstifte EUDAMEDDrill for Pin end Head Master FDA UDI
- Model / Reference
- 16202 EUDAMED6325-3 EUDAMEDFDA UDI
- Description
- Drill for Pin end Head Master FDA UDI
Identifiers
- Primary DI / UDI-DI
- E312632531 EUDAMEDFDA UDI
- Basic UDI-DI
- ++E31216202DF EUDAMED
- Unit of Use DI
- E31263253101 EUDAMED
- FDA Product Code
- DZA FDA UDI
- EMDN Code
- Q010105 RECONSTRUCTION ENDODONTIC PINS EUDAMED
- GMDN Term
- Pin/post dental drill bit FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 872.4130 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
Bohrer für Pin und Head Master 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 | ++E31216202DF | 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 9c9c8c89-c393-4334-bb5b-bd1111e39e72 61 fields · synced Jul 9, 2026
- FDA UDI ee4870c4-60f9-4cd7-8a43-39ff4078f268 33 fields · synced May 30, 2026