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Ceramill Sintron 98x20 F

by Amann Girrbach AG

Ref 767522

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number++E494SINTRONE3 Basic UDI-DI E4947675221UDI-DIDate4 Jun 2025RegisteredStatusActive
United StatesGUDID listing GUDID NumberE4947675221 UDI-DI Date30 Sep 2022ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Ceramill Sintron 98x20 F EUDAMED
Ceramill Sintron® GUDID
Generic Name
Dental casting non-noble alloy
Device Name
CoCr milling alloy
Model / Ref / Catalog
767522, Ceramill Sintron 98x20 F
Primary DI / UDI-DI
E4947675221
Basic UDI-DI
++E494SINTRONE3
FDA Product Code
EJH
EMDN Code
Q010601 Dental alloys
GMDN Term
Dental casting non-noble alloy
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
872.3710
EU market of registration
Austria
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 3 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
767522
GUDID
Ceramill Sintron 98x20 F
Device ClassEUDAMED
Class IIa
GUDID
Class II
ImplantableEUDAMED
Yes
GUDID
No

Manufacturer details

EUDAMED SRN
AT-MF-000000252

Related devices

Category: Dental casting non-noble alloy

Other devices from Amann Girrbach AG

See all devices from Amann Girrbach AG →

Properties

  • Implantable YesEUDAMEDNoGUDID
  • CMR Substance
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Serial Number
  • Expiration Date
  • Manufacturing Date

Other properties (16)

  • Sterile: No
  • Single Use: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No