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Transbond™ Plus 712-091

by 3M Unitek Corporation

Ref 712-091

Transbond Plus 712-091 is a dentine bonding agent/set (EU MDD Class IIa; FDA Class II; FDA product code KLE, Agent, Tooth Bonding, Resin) made by 3M Unitek Corporation, registered in EUDAMED on 30 Oct 2026 (Basic UDI-DI B-00652221109187) and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 00652221109187), 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-00652221109187 Basic UDI-DI 00652221109187UDI-DIDate30 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00652221109187 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00652221109187 registered 30 Oct 2026 Active
  • FDA GUDID UDI-DI 00652221109187 listed 24 Sep 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00652221109187
  2. Registered EUDAMED B-00652221109187

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  • Withdrawn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
3M™ Transbond™ EUDAMED
Transbond™ Plus GUDID
Generic name
Dentine bonding agent/set
Device name
3M™ Transbond™ Plus Self Etching Primer, 712-091, 20/Pk
Model / Ref / Catalog
712-091
Primary DI / UDI-DI
00652221109187
Basic UDI-DI
B-00652221109187
FDA product code
KLE
EMDN code
Q01010104 Dental bonding agents
GMDN term
Dentine bonding agent/set
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
872.3200
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
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: Dentine bonding agent/set

Similar devices in this category

Other devices filed under DENTAL BONDING AGENTS.

Other devices from 3M Unitek Corporation

See all devices from 3M Unitek Corporation →

Properties

  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (21, all answered No)