Identity
- Trade Name
- ZERADRILL™ R14 (REGULAR 14mm) EUDAMEDFDA UDI
- Generic Name
- Steel dental bur, reusable FDA UDI
- Device Name
- Surgical drills EUDAMEDTools FDA UDI
- Model / Reference
- T36614 EUDAMEDFDA UDI
- Description
- Tools FDA UDI
Identifiers
- Catalog Number
- T36614 FDA UDI
- Primary DI / UDI-DI
- 07640161391406 EUDAMEDFDA UDI
- Basic UDI-DI
- 764016139T3XXXXKL2ASDR2 EUDAMED
- Direct Marketing DI
- 07640161391406 EUDAMED
- FDA Product Code
- NDP FDA UDI
- EMDN Code
- L1104 BITS FOR NEUROSURGERY DRILLS, REUSABLE EUDAMED
- GMDN Term
- Steel dental bur, 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
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
ZERADRILL™ R14 (REGULAR 14mm) 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 | 764016139T3XXXXKL2ASDR2 | 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-MF-000024169
- Authorised Representative
- CeramTec Dentalvertriebs GmbH DE-AR-000020220
Sources (2)
- EUDAMED 61ee63f8-3574-44ef-9fe3-f45699c5b0dc 61 fields · synced Jun 18, 2026
- FDA UDI 639320b1-3a33-4d87-8d85-57674315c94f 36 fields · synced May 30, 2026