Identity
- Trade Name
- Ceramill Sintron 98x10 F EUDAMEDCeramill Sintron® FDA UDI
- Generic Name
- Dental casting non-noble alloy FDA UDI
- Device Name
- CoCr milling alloy EUDAMED
- Model / Reference
- 767517 EUDAMEDCeramill Sintron 98x10 F FDA UDI
Identifiers
- Catalog Number
- 767517 FDA UDI
- Primary DI / UDI-DI
- E4947675171 EUDAMEDFDA UDI
- Basic UDI-DI
- ++E494SINTRONE3 EUDAMED
- FDA Product Code
- EJH FDA UDI
- EMDN Code
- Q010601 DENTAL ALLOYS EUDAMED
- GMDN Term
- Dental casting non-noble alloy FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3710 FDA UDI
- Market of Registration
- Austria EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
Yes
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
Yes
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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Ceramill Sintron 98x10 F by Amann Girrbach AG — 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 | ++E494SINTRONE3 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Amann Girrbach AG
- EUDAMED SRN
- AT-MF-000000252
Sources (2)
- EUDAMED ff2d137a-d98a-423c-9a33-d6992da77bc4 61 fields · synced Jun 20, 2026
- FDA UDI 602526e1-5fe1-4023-b340-b10f6cee5d7f 34 fields · synced May 30, 2026