Identity
- Trade Name
- ZERAMEX® T Tiefenlehre, 4pcs. EUDAMEDZERAMEX T depth gage FDA UDI
- Generic Name
- Dental implantation depth/angle gauge, reusable FDA UDI
- Device Name
- Depth gauge EUDAMEDTools FDA UDI
- Model / Reference
- T38650 EUDAMEDFDA UDI
- Description
- Tools FDA UDI
Identifiers
- Catalog Number
- T38650 FDA UDI
- Primary DI / UDI-DI
- 07640161391499 EUDAMEDFDA UDI
- Basic UDI-DI
- 764016139T38650KL2ADGST EUDAMED
- Direct Marketing DI
- 07640161391499 EUDAMED
- FDA Product Code
- NDP FDA UDI
- EMDN Code
- L0180 SHARP INSTRUMENTS, REUSABLE - ACCESSORIES EUDAMED
- GMDN Term
- Dental implantation depth/angle gauge, 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
ZERAMEX® T Tiefenlehre, 4pcs. 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 | 764016139T38650KL2ADGST | 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 d892f8df-68b1-4cd4-9795-d646587c6393 61 fields · synced Jul 19, 2026
- FDA UDI b713a932-efbc-45bb-bad5-e27cbb503565 36 fields · synced May 30, 2026