← Back to catalogue
ZERAMEX® XT Drill Stop, for WIDE Drill
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref XT37651
Identity
- Trade Name
- ZERAMEX® XT Drill Stop, for WIDE Drill EUDAMEDFDA UDI
- Generic Name
- Fixture/appliance dental drill bit, reusable FDA UDI
- Device Name
- Drill stop EUDAMEDTools FDA UDI
- Model / Reference
- XT37651 EUDAMEDFDA UDI
- Description
- Tools FDA UDI
Identifiers
- Catalog Number
- XT37651 FDA UDI
- Primary DI / UDI-DI
- 07640161392748 EUDAMEDFDA UDI
- Basic UDI-DI
- 764016139XT3X651KL2ADSF5 EUDAMED
- FDA Product Code
- NDP FDA UDI
- EMDN Code
- L0180 SHARP INSTRUMENTS, REUSABLE - ACCESSORIES EUDAMED
- GMDN Term
- Fixture/appliance dental drill bit, 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
No
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 Drill Stop, for WIDE Drill 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 | 764016139XT3X651KL2ADSF5 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | 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 0016f772-904f-4cf5-bff7-32dde94c1917 61 fields · synced Jun 20, 2026
- FDA UDI 15b595b0-a971-43d2-95ed-84b980f0969b 36 fields · synced May 30, 2026