Identity
- Trade Name
- artBloc Temp FDA UDI
- Generic Name
- Temporary dental crown/bridge FDA UDI
- Device Name
- 10 artBloc Temp, PMMA-bloc 15,5x19,0x39,0mm shade D4 translucent FDA UDI
- Model / Reference
- 10 artBloc Temp, PMMA-bloc 15,5x19,0x39,0mm shade D4 translucent FDA UDI
- Description
- 10 artBloc Temp, PMMA-bloc 15,5x19,0x39,0mm shade D4 translucent FDA UDI
Identifiers
- Catalog Number
- 1017665 FDA UDI
- Primary DI / UDI-DI
- D7091017665 FDA UDI
- 510(k) Number
- K080556 FDA UDI
- FDA Product Code
- EBG FDA UDI
- GMDN Term
- Temporary dental crown/bridge FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3770 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA 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
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Temporary dental crown/bridge
artBloc Temp by Merz Dental GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K080556 also covers:
- artBloc Temp — Merz Dental GmbH
- artBloc Temp — Merz Dental GmbH
- artBloc Temp — Merz Dental GmbH
- artBloc Temp — Merz Dental GmbH
- artBloc Temp — Merz Dental GmbH
- artBloc Temp — Merz Dental GmbH
- artBloc Temp — Merz Dental GmbH
- artBloc Temp — Merz Dental GmbH
- artBloc Temp — Merz Dental GmbH
- artBloc Temp — Merz Dental GmbH
- artBloc Temp — Merz Dental GmbH
- artBloc Temp — Merz Dental GmbH
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Merz Dental GmbH
Sources (1)
- FDA UDI 7bed16a4-5c0f-46dd-ae86-5aebb917d0b1 36 fields · synced Jun 8, 2026