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ZERAMEX® XT Prosthetic Tray, incl. Ratchet
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref XT48865Model Prosthetic Tray, incl. Ratchet
Identity
- Trade Name
- ZERAMEX® XT Prosthetic Tray, incl. Ratchet EUDAMEDZeramex XT Prosthetic Tray, incl. Ratchet FDA UDI
- Generic Name
- Dental/maxillofacial surgical procedure kit, non-medicated, reusable FDA UDI
- Device Name
- Tools FDA UDI
- Model / Reference
- Prosthetic Tray, incl. Ratchet EUDAMEDXT48865 EUDAMEDFDA UDI
- Description
- Tools FDA UDI
Identifiers
- Catalog Number
- XT48865 FDA UDI
- Primary DI / UDI-DI
- 07640161392830 EUDAMEDFDA UDI
- Basic UDI-DI
- 764016139XT48865KL22PKNH EUDAMED
- FDA Product Code
- NDP FDA UDI
- EMDN Code
- L159099 ODONTOSTOMATOLOGY INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Dental/maxillofacial surgical procedure kit, non-medicated, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 872.3980 FDA UDI
- Medical Purpose
- The kits are intended to enable the placing and/or restoration of dental implants EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
ZERAMEX® XT Prosthetic Tray, incl. Ratchet 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 | 764016139XT48865KL22PKNH | 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-PR-000042804
Sources (2)
- EUDAMED 9d323210-6534-4408-865c-ec39d7181bb6 61 fields · synced Jun 18, 2026
- FDA UDI b83ff14c-dc2b-4094-92cf-af2e6f821cf5 36 fields · synced May 30, 2026