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28012

by Gebdi Dental-Products GmbH

Ref 28012

28012 is a device classified as Class IIa in the EU and Class II in the US made by Gebdi Dental-Products GmbH, registered in EUDAMED on 30 Jun 2026 (Basic UDI-DI B-+EGEB28012) and listed in FDA GUDID since 25 Oct 2016 (UDI-DI +EGEB28012), active as of 24 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 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-+EGEB28012 Basic UDI-DI +EGEB28012UDI-DIDate30 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number+EGEB28012 UDI-DI Date25 Oct 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-+EGEB28012 registered 30 Jun 2026 Active
  • FDA GUDID UDI-DI +EGEB28012 listed 25 Oct 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID +EGEB28012
  2. Registered EUDAMED B-+EGEB28012

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  • Withdrawn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
TRIBOS 501 Kunststoffzähne
Generic name
Partial denture
Device name
TRIBOS 501 Kunststoffzähne VT24-OK-C3
Model / reference
28012
Primary DI / UDI-DI
+EGEB28012 EUDAMED
EGEB280121 GUDID
Basic UDI-DI
B-+EGEB28012
FDA product code
ELM
EMDN code
Q01020601 Mobile dental prostheses
GMDN term
Partial denture
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
872.3590
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
Primary DI / UDI-DIEUDAMED
+EGEB28012
GUDID
EGEB280121
Device classEUDAMED
Class IIa
GUDID
Class II

The registries describe this device under different primary UDI-DIs (EUDAMED lists +EGEB28012; FDA GUDID lists EGEB280121), 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: Partial denture

Similar devices in this category

Other devices filed under DENTAL PROSTHESES (FOR DENTAL IMPLANTS SEE P010201).

Other devices from Gebdi Dental-Products GmbH

See all devices from Gebdi Dental-Products GmbH →

Properties

  • Single use
  • Lot / batch number
  • Expiration date
Other properties (20, all answered No)