Identity
- Trade Name
- Ceramill FDA UDI
- Generic Name
- Temporary dental crown/bridge FDA UDI
- Model / Reference
- Ceramill A-Temp ML A2/A3 98x20 FDA UDI
Identifiers
- Catalog Number
- 761060 FDA UDI
- Primary DI / UDI-DI
- E4947610601 FDA UDI
- 510(k) Number
- K191843 FDA UDI
- FDA Product Code
- POW FDA UDIEBG 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
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Temporary dental crown/bridge
Ceramill by Amann Girrbach AG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Temporary dental crown/bridge.
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- VIPI BLOCK — Vipi Indústria, Comércio, Exportação e Importação de Produtos Odontológicos Ltda. · Class II
- VIPI BLOCK — Vipi Indústria, Comércio, Exportação e Importação de Produtos Odontológicos Ltda. · Class II
- IDODENTINE — UNION DENTAL SA · Class II
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- Pure PMMA Disc — QUEST DENTAL MATERIAL CORPORATION · Class II
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Cleared under the same submission
K191843 also covers:
- Ceramill — Amann Girrbach AG
- Ceramill — Amann Girrbach AG
- Ceramill — Amann Girrbach AG
- Ceramill — Amann Girrbach AG
- Ceramill — Amann Girrbach AG
- Ceramill — Amann Girrbach AG
- Ceramill — Amann Girrbach AG
- Ceramill — Amann Girrbach AG
- Ceramill — Amann Girrbach AG
- Ceramill — Amann Girrbach AG
- Ceramill — Amann Girrbach AG
- Ceramill — Amann Girrbach AG
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 |
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Manufacturer
- Manufacturer
- Amann Girrbach AG
Sources (1)
- FDA UDI a4f753ca-569c-484d-a852-aee325a9a8cc 35 fields · synced May 31, 2026