Identity
- Trade Name
- ZERAMEX® XT Rescue Instrument 28mm EUDAMEDZERAMEX XT Rescue Instrument 28mm FDA UDI
- Generic Name
- Dental implant extractor FDA UDI
- Device Name
- Rescue Instrument EUDAMEDTools FDA UDI
- Model / Reference
- R98130 EUDAMEDFDA UDI
- Description
- Tools FDA UDI
Identifiers
- Catalog Number
- R98130 FDA UDI
- Primary DI / UDI-DI
- 07640161397279 EUDAMEDFDA UDI
- Basic UDI-DI
- 764016139R98130K01RI2A EUDAMED
- Direct Marketing DI
- 07640161397279 EUDAMED
- FDA Product Code
- NDP FDA UDI
- EMDN Code
- Q010599 DENTAL INSTRUMENTS, SINGLE-USE - OTHER EUDAMED
- GMDN Term
- Dental implant extractor FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA 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
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
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® XT Rescue Instrument 28mm 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 | 764016139R98130K01RI2A | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- CeramTec Schweiz GmbH
- EUDAMED SRN
- CH-MF-000024169
- Authorised Representative
- CeramTec Dentalvertriebs GmbH DE-AR-000020220
Sources (2)
- EUDAMED 3bef1ed1-8de7-4f17-a8ae-b0843a228e37 61 fields · synced Jul 31, 2026
- FDA UDI ca7b2aa1-1596-48a8-a35d-0655eae1223c 36 fields · synced May 30, 2026