Identity
- Trade Name
- Ceramill Sintron 98x 14 N EUDAMEDCeramill Sintron® FDA UDI
- Generic Name
- Dental casting non-noble alloy FDA UDI
- Device Name
- CoCr milling alloy EUDAMED
- Model / Reference
- 761128 EUDAMEDSintron 98x 14 N FDA UDI
Identifiers
- Catalog Number
- 761128 FDA UDI
- Primary DI / UDI-DI
- E4947611281 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
Yes
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
Category: Dental casting non-noble alloy
Ceramill Sintron 98x 14 N by Amann Girrbach AG — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental casting non-noble alloy.
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- System Ti5-Blank 98, 5 x 25 mm — Adentatec GmbH Competence in Dental · Class II
- Magnum Solare — Mesa Italia S.r.l. · Class IIa
- NIRANIUM — CMP INDUSTRIES LLC · Class II
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 (3)
- EUDAMED 60b668d6-398f-482c-bac8-8087837939db 61 fields · synced Jul 11, 2026
- FDA UDI 956851b5-d6f3-41d2-9116-59683963bc7e 34 fields · synced May 30, 2026
- EUDAMED 049b2ded-651a-40ec-9e82-92457fadc6ca 61 fields · synced Jul 11, 2026