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Ceramill A-Splint 98x16/10

by Amann Girrbach AG

Ref 761088

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

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID NumberE4947610881 UDI-DI Date21 Jan 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number++E494ASPLINT6D Basic UDI-DI E4947610881UDI-DIDate29 Apr 2025RegisteredStatusActive

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.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

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  • Withdrawn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 A-Splint 98x16/10 EUDAMED
Ceramill A-Splint GUDID
Generic Name
Temporary dental crown/bridge
Device Name
Polymers temporary / Kunststoffe temporär
Model / Ref / Catalog
761088, Ceramill A-Splint 98x16/10
Primary DI / UDI-DI
E4947610881
Basic UDI-DI
++E494ASPLINT6D
510(k) Number
FDA Product Code
MQC
EMDN Code
Q010699 Materials for the preparation of custom-made dental devices - other
GMDN Term
Temporary dental crown/bridge
Device Class
Class IIa EUDAMED
U GUDID
EU market of registration
Austria
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
761088
GUDID
Ceramill A-Splint 98x16/10
Device ClassEUDAMED
Class IIa
GUDID
U

Manufacturer details

EUDAMED SRN
AT-MF-000000252

Other devices from Amann Girrbach AG

See all devices from Amann Girrbach AG →

Properties

  • Prescription Use
  • Lot / Batch Number
  • Serial Number
  • Expiration Date
  • Manufacturing Date

Other properties (19)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: 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
  • Premarket Exempt: No