Skip to content

3M™ Victory Series™ 905-127

by 3M Unitek Corporation

Ref 905-127

3M™ Victory Series™ 905-127 is a device classified as Class IIa in the EU and Class I in the US made by 3M Unitek Corporation, registered in EUDAMED on 29 Sep 2026 (Basic UDI-DI B-00652221112804) and listed in FDA GUDID since 8 Dec 2022 (UDI-DI 00652221112804), 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-00652221112804 Basic UDI-DI 00652221112804UDI-DIDate29 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00652221112804 UDI-DI Date8 Dec 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00652221112804 registered 29 Sep 2026 Active
  • FDA GUDID UDI-DI 00652221112804 listed 8 Dec 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00652221112804
  2. Registered EUDAMED B-00652221112804

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  • Withdrawn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™ Victory Series™
Generic name
Orthodontic bracket, metal
Model / Ref / Catalog
905-127
Primary DI / UDI-DI
00652221112804
Basic UDI-DI
B-00652221112804
FDA product code
ECM
EMDN code
Q010402 Orthodontic bands
GMDN term
Orthodontic bracket, metal
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
872.5410
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 I

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class I in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Orthodontic bracket, metal

Similar devices in this category

Other devices filed under ORTHODONTIC BANDS.

Other devices from 3M Unitek Corporation

See all devices from 3M Unitek Corporation →

Properties

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