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3M™ Unitek™ 4297-981

by 3M Unitek Corporation

Ref 4297-981

3M™ Unitek™ 4297-981 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 3 Sep 2026 (Basic UDI-DI B-00652221081551) and listed in FDA GUDID since 8 Dec 2022 (UDI-DI 00652221081551), 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-00652221081551 Basic UDI-DI 00652221081551UDI-DIDate3 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00652221081551 UDI-DI Date8 Dec 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00652221081551 registered 3 Sep 2026 Active
  • FDA GUDID UDI-DI 00652221081551 listed 8 Dec 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00652221081551
  2. Registered EUDAMED B-00652221081551

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  • Withdrawn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™ Unitek™ OrthoForm™ EUDAMED
3M™ Unitek™ GUDID
Generic name
Orthodontic archwire
Model / Ref / Catalog
4297-981
Primary DI / UDI-DI
00652221081551
Basic UDI-DI
B-00652221081551
FDA product code
DZC
EMDN code
Q010405 Orthodontic wires
GMDN term
Orthodontic archwire
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 archwire

Similar devices in this category

Other devices filed under ORTHODONTIC WIRES.

Other devices from 3M Unitek Corporation

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Properties

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