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Celtra Ceram 650138

by Dentsply International

Ref 650138Model Celtra Ceram Dentin - A4, 50G

Celtra Ceram 650138 is a device classified as Class IIa in the EU and Class II in the US made by Dentsply International, registered in EUDAMED on 30 Oct 2026 (Basic UDI-DI B-D0016501381) and listed in FDA GUDID since 16 Oct 2024 (UDI-DI D0016501381), active as of 7 Nov 2026.

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

CE MDD

Valid until

No date given

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

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-D0016501381 Basic UDI-DI D0016501381UDI-DIDate30 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID NumberD0016501381 UDI-DI Date16 Oct 2024ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-D0016501381 registered 30 Oct 2026 Active
  • FDA GUDID UDI-DI D0016501381 listed 16 Oct 2024 Listed

Timeline

2 dated events

  1. Listed FDA GUDID D0016501381
  2. Registered EUDAMED B-D0016501381

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Celtra® Ceram EUDAMED
Celtra Ceram GUDID
Generic name
Dental appliance fabrication material, ceramic
Model / Ref / Catalog
650138, Celtra Ceram Dentin - A4, 50G
Primary DI / UDI-DI
D0016501381
Basic UDI-DI
B-D0016501381
FDA product code
EIH
EMDN code
Q010299 Prosthetic dentistry devices - other
GMDN term
Dental appliance fabrication material, ceramic
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
872.6660
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II
ImplantableEUDAMED
Yes
GUDID
No

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Dental appliance fabrication material, ceramic

Similar devices in this category

Other devices filed under DEVICES FOR PROSTHETIC DENTISTRY.

Other devices from Dentsply International

See all devices from Dentsply International →

Properties

  • Implantable YesEUDAMEDNoGUDID
  • Prescription use
  • Lot / batch number
Other properties (22, all answered No)