Identity
- Trade Name
- Ceramill A-Splint 98x20 EUDAMEDCeramill FDA UDI
- Generic Name
- Temporary dental crown/bridge FDA UDI
- Device Name
- Polymers temporary / Kunststoffe temporär EUDAMED
- Model / Reference
- 761086 EUDAMEDCeramill A-Splint 98x20 FDA UDI
Identifiers
- Catalog Number
- 761248 FDA UDI
- Primary DI / UDI-DI
- E4947610861 EUDAMEDFDA UDI
- Basic UDI-DI
- ++E494ASPLINT6D EUDAMED
- 510(k) Number
- K191836 FDA UDI
- FDA Product Code
- MQC FDA UDI
- EMDN Code
- Q010699 MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER EUDAMED
- GMDN Term
- Temporary dental crown/bridge FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDU FDA UDI
- Market of Registration
- Austria EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
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
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 U — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
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
- 10TEMP — UNION DENTAL SA · Class II
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- Pure PMMA Disc — QUEST DENTAL MATERIAL CORPORATION · Class II
Cleared under the same submission
K191836 also covers:
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class U | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class U | Pending data |
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Manufacturer
- Manufacturer
- Amann Girrbach AG
Sources (2)
- FDA UDI 9b96958d-788f-44e4-87d0-4b2c01e0db64 34 fields · synced Jun 18, 2026
- EUDAMED 5c00fa21-6d3c-459d-8b92-55be83b9eb22 61 fields · synced Jun 18, 2026