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3M™ 320-452

by 3M Unitek Corporation

Ref 320-452

3M™ 320-452 is a device classified as Class IIa in the EU and Class II in the US made by 3M Unitek Corporation, registered in EUDAMED on 29 Sep 2026 (Basic UDI-DI B-00652221069788) and listed in FDA GUDID since 4 Aug 2017 (UDI-DI 00652221069788), 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-00652221069788 Basic UDI-DI 00652221069788UDI-DIDate29 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00652221069788 UDI-DI Date4 Aug 2017ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00652221069788 registered 29 Sep 2026 Active
  • FDA GUDID UDI-DI 00652221069788 listed 4 Aug 2017 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00652221069788
  2. Registered EUDAMED B-00652221069788

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  • Withdrawn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™
Generic name
Orthodontic extraoral headgear
Device name
Unitek(TM) Series 5 Facebow, 320-452 Friction Stop Short .045 Diameter 1/EA
Model / Ref / Catalog
320-452
Primary DI / UDI-DI
00652221069788
Basic UDI-DI
B-00652221069788
FDA product code
DZB
EMDN code
Q010401 Orthodontic face bows
GMDN term
Orthodontic extraoral headgear
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
872.5500
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: Orthodontic extraoral headgear

Similar devices in this category

Other devices filed under ORTHODONTIC FACE BOWS.

Other devices from 3M Unitek Corporation

See all devices from 3M Unitek Corporation →

Properties

  • Prescription use
  • Premarket exempt
  • Lot / batch number
Other properties (22, all answered No)