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Ceramco® 3 Dentin C1

by Dentsply International

Ref 301147Model Dentin C1

Ceramco® 3 Dentin C1 (301147) is a device classified as Class IIa in the EU and Class II in the US made by Dentsply International, registered in EUDAMED on 4 Nov 2026 (Basic UDI-DI B-D0013011470) and listed in FDA GUDID since 21 Sep 2016 (UDI-DI D0013011470), 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-D0013011470 Basic UDI-DI D0013011470UDI-DIDate4 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID NumberD0013011470 UDI-DI Date21 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-D0013011470 registered 4 Nov 2026 Active
  • FDA GUDID UDI-DI D0013011470 listed 21 Sep 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID D0013011470
  2. Registered EUDAMED B-D0013011470

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  • Withdrawn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 DENTIN C1 1oz EUDAMED
Ceramco® 3 GUDID
Generic name
Dental appliance fabrication material, ceramic
Model / Ref / Catalog
Dentin C1, 301147
Primary DI / UDI-DI
D0013011470 EUDAMED
D0013011471 GUDID
Basic UDI-DI
B-D0013011470
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 · 3 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
D0013011470
GUDID
D0013011471
Device classEUDAMED
Class IIa
GUDID
Class II
ImplantableEUDAMED
Yes
GUDID
No

The registries describe this device under different primary UDI-DIs (EUDAMED lists D0013011470; FDA GUDID lists D0013011471), so their flags are not compared. 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
  • Manufacturing date
Other properties (21, all answered No)