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Celtra® Ceram

by Dentsply International 73 variants

Ref 615138Model Celtra Ceram Dentin - A4, 15G

Celtra® Ceram (615138) is a device classified as Class IIa in the EU and Class II in the US made by Dentsply International, registered in EUDAMED on 29 Oct 2026 (Basic UDI-DI B-D0016151381) and listed in FDA GUDID since 4 Nov 2016 (UDI-DI D0016151381), 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-D0016151381 Basic UDI-DI D0016151381UDI-DIDate29 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID NumberD0016151381 UDI-DI Date4 Nov 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-D0016151381 registered 29 Oct 2026 Active
  • FDA GUDID UDI-DI D0016151381 listed 4 Nov 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID D0016151381
  2. Registered EUDAMED B-D0016151381

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  • Withdrawn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® GUDID
Generic name
Dental appliance fabrication material, ceramic
Model / Ref / Catalog
Celtra Ceram Dentin - A4, 15G, 615138, Ceram
Primary DI / UDI-DI
D0016151381
Basic UDI-DI
B-D0016151381
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
Size
Weight — 15 Gram

Truth per registry

2 sources · 3 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
Celtra Ceram Dentin - A4, 15G
615138
GUDID
Ceram
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 PROSTHETIC DENTISTRY DEVICES - OTHER.

Other devices from Dentsply International

See all devices from Dentsply International →

Properties

  • Implantable YesEUDAMEDNoGUDID
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (20, all answered No)