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3M™ 4006-158

by 3M Unitek Corporation

Ref 4006-158

3M 4006-158 is an orthodontic bracket (EU MDD Class IIa; FDA Class II; FDA product code NJM, Bracket, ceramic, orthodontic) made by 3M Unitek Corporation, registered in EUDAMED on 30 Oct 2026 (Basic UDI-DI B-00652221228093) and listed in FDA GUDID since 25 Apr 2026 (UDI-DI 00652221228093), 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-00652221228093 Basic UDI-DI 00652221228093UDI-DIDate30 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00652221228093 UDI-DI Date25 Apr 2026ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00652221228093 registered 30 Oct 2026 Active
  • FDA GUDID UDI-DI 00652221228093 listed 25 Apr 2026 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00652221228093
  2. Registered EUDAMED B-00652221228093

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  • Withdrawn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™ Clarity™ APC™ EUDAMED
3M™ GUDID
Generic name
Orthodontic bracket, ceramic
Device name
3M™ Clarity Advanced Ceramic Brackets Kit, High Torque, .022, U, 3x3, Cuspid Hk, APC™ Flash-Free, 4006-158, 6/Kit
Model / Ref / Catalog
4006-158
Description
4006-158 APC FF Clarity ADVANCED Hi TQ U Lt/Rt 3X3 CHk 022
Primary DI / UDI-DI
00652221228093
Basic UDI-DI
B-00652221228093
FDA product code
NJM
EMDN code
Q010403 Orthodontic brackets and buttons
GMDN term
Orthodontic bracket, ceramic
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
872.5470
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.

Similar devices in this category

Other devices filed under ORTHODONTIC BRACKETS AND BUTTONS.

Other devices from 3M Unitek Corporation

See all devices from 3M Unitek Corporation →

Properties

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