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Ceramco® 3 Powder Opaque A4

by Dentsply International

Ref 301008Model Powder Opaque A4

Ceramco® 3 Powder Opaque A4 (301008) is a device classified as Class IIa in the EU and Class II in the US made by Dentsply International, registered in EUDAMED on 2 Nov 2026 (Basic UDI-DI B-D0013010081) and listed in FDA GUDID since 21 Sep 2016 (UDI-DI D0013010081), 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-D0013010081 Basic UDI-DI D0013010081UDI-DIDate2 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID NumberD0013010081 UDI-DI Date21 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-D0013010081 registered 2 Nov 2026 Active
  • FDA GUDID UDI-DI D0013010081 listed 21 Sep 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID D0013010081
  2. Registered EUDAMED B-D0013010081

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  • Withdrawn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
C3 POWDER OPAQUE A4 1oz EUDAMED
Ceramco® 3 GUDID
Generic name
Dental appliance fabrication material, ceramic
Model / Ref / Catalog
Powder Opaque A4, 301008
Primary DI / UDI-DI
D0013010081
Basic UDI-DI
B-D0013010081
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 — 28.4 Gram

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.

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Properties

  • Implantable YesEUDAMEDNoGUDID
  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (21, all answered No)