Identity
- Trade Name
- ZERAMEX® Prosthetic Key, 23mm EUDAMEDFDA UDI
- Generic Name
- Steel dental bur, reusable FDA UDI
- Device Name
- Prosthetic key EUDAMEDTools FDA UDI
- Model / Reference
- XT38623 EUDAMEDFDA UDI
- Description
- Tools FDA UDI
Identifiers
- Catalog Number
- XT38623 FDA UDI
- Primary DI / UDI-DI
- 07640161392625 EUDAMEDFDA UDI
- Basic UDI-DI
- 764016139XT3XXXXKL2APKG2 EUDAMED
- Direct Marketing DI
- 07640161392625 EUDAMED
- FDA Product Code
- NDP FDA UDI
- EMDN Code
- Z12019001 SURGICAL WIRE APPLICATION EQUIPMENT EUDAMED
- GMDN Term
- Steel dental bur, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 872.3980 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
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
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
ZERAMEX® Prosthetic Key, 23mm by CeramTec Schweiz GmbH — 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 | 764016139XT3XXXXKL2APKG2 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- CeramTec Schweiz GmbH
- EUDAMED SRN
- CH-MF-000024169
- Authorised Representative
- CeramTec Dentalvertriebs GmbH DE-AR-000020220
Sources (2)
- EUDAMED e1eb749a-7d23-4029-b5fc-721eaf81d4f1 61 fields · synced Jul 25, 2026
- FDA UDI 7d2ce058-dadd-4ab8-a30c-d8dcd6f22128 36 fields · synced May 30, 2026