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DENTCA Denture Base DENTCA Denture Base II

by Dentca, Inc. 3 variants

Ref 01304Model Denture Base II

DENTCA Denture Base DENTCA Denture Base II is a dental appliance fabrication material (EU MDD Class IIa; FDA Class II; FDA product code EBI, Resin, Denture, Relining, Repairing, Rebasing) made by Dentca, Inc., registered in EUDAMED on 9 Jun 2026 (Basic UDI-DI B-00856551007278) and listed in FDA GUDID since 26 Jun 2017 (UDI-DI 00856551007278), active as of 22 Oct 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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00856551007278 Basic UDI-DI 00856551007278UDI-DIDate9 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00856551007278 UDI-DI Date26 Jun 2017ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00856551007278 registered 9 Jun 2026 Active
  • FDA GUDID UDI-DI 00856551007278 listed 26 Jun 2017 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00856551007278
  2. Registered EUDAMED B-00856551007278

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  • Withdrawn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
DENTCA Denture Base II EUDAMED
DENTCA Denture Base GUDID
Generic name
Dental appliance fabrication material, resin
Model / reference
Denture Base II EUDAMED
01304 EUDAMED
DENTCA Denture Base II GUDID
Primary DI / UDI-DI
00856551007278
Basic UDI-DI
B-00856551007278
FDA product code
EBI
EMDN code
Q0102050102 Dental rebasing resins
GMDN term
Dental appliance fabrication material, resin
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
872.3760
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Size
Weight — 1 Kilogram

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
Denture Base II
01304
GUDID
DENTCA Denture Base II
Device classEUDAMED
Class IIa
GUDID
Class II

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, resin

Similar devices in this category

Other devices filed under DENTAL REBASING RESINS.

Other devices from Dentca, Inc.

See all devices from Dentca, Inc. →

Properties

  • Prescription use
  • Lot / batch number
  • Serial number
  • Expiration date
Other properties (19, all answered No)