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CERALOG® PL Implant Re-Set
EUDAMEDFDA UDIClass I (EU MDR)
Ref HP5900.2000Model Rescue-Set
Identity
- Trade Name
- CERALOG® PL Implant Re-Set EUDAMEDFDA UDI
- Generic Name
- Dental/maxillofacial surgical procedure kit, non-medicated, reusable FDA UDI
- Model / Reference
- Rescue-Set EUDAMEDHP5900.2000 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- HP5900.2000 FDA UDI
- Primary DI / UDI-DI
- 07640161397132 EUDAMEDFDA UDI
- Basic UDI-DI
- 764016139R98000KL22RKNE EUDAMED
- FDA Product Code
- NDP FDA UDI
- EMDN Code
- P01020180 DENTAL IMPLANTS - ACCESSORIES EUDAMED
- GMDN Term
- Dental/maxillofacial surgical procedure kit, non-medicated, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA 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
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
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
CERALOG® PL Implant Re-Set by CeramTec Schweiz GmbH — Class I — 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 | 764016139R98000KL22RKNE | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- CeramTec Schweiz GmbH
- EUDAMED SRN
- CH-PR-000042804
Sources (2)
- EUDAMED 42db5cf9-abdd-45f1-bb09-209748e1d179 61 fields · synced Jul 14, 2026
- FDA UDI 55ca949c-09fa-4607-a164-1f1066458e32 34 fields · synced May 26, 2026