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ZERAMEX® XT Surgery Tray, fully equipped
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref XT48854Model Surgery Tray, fully equipped
Identity
- Trade Name
- ZERAMEX® XT Surgery Tray, fully equipped EUDAMEDZeramex XT Surgery Tray, fully equipped FDA UDI
- Generic Name
- Instrument tray, reusable FDA UDI
- Device Name
- Tools FDA UDI
- Model / Reference
- Surgery Tray, fully equipped EUDAMEDXT48854 EUDAMEDFDA UDI
- Description
- Tools FDA UDI
Identifiers
- Catalog Number
- XT48854 FDA UDI
- Primary DI / UDI-DI
- 07640161392809 EUDAMEDFDA UDI
- Basic UDI-DI
- 764016139XT48854KL22SKMN EUDAMED
- FDA Product Code
- NDP FDA UDI
- EMDN Code
- L159016 DENTAL SURGERY INSTRUMENT KITS, REUSABLE EUDAMED
- GMDN Term
- Instrument tray, 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
Category: Dental/maxillofacial surgical procedure kit, non-medicated, reusable
ZERAMEX® XT Surgery Tray, fully equipped by CeramTec Schweiz GmbH — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Also classified as Dental/maxillofacial surgical procedure kit, non-medicated, reusable.
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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 | 764016139XT48854KL22SKMN | 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 2454b127-f30e-45f3-8414-b8241a2d0b52 61 fields · synced Jul 27, 2026
- FDA UDI 7b760fad-d9c6-490d-a403-6767428458f1 36 fields · synced May 30, 2026