Skip to content

3M™ SmartClip™APC™

by Solventum Orthodontics Corporation 4 variants

Ref 4004-432

Active European Union. Also listed in GUDID (US).

CE MDD

Valid until

Not listed

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

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00652221228222 Basic UDI-DI 00652221228222UDI-DIDate27 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00652221228222 UDI-DI Date7 May 2026ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

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  • Withdrawn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™ SmartClip™APC™ EUDAMED
3M™ SmartClip™ GUDID
Generic Name
Orthodontic bracket adhesive
Model / Ref / Catalog
4004-432 EUDAMED
4004--432 GUDID
Primary DI / UDI-DI
00652221228222
Basic UDI-DI
B-00652221228222
FDA Product Code
DYH, EJF
EMDN Code
Q010403 Orthodontic brackets and buttons
GMDN Term
Orthodontic bracket adhesive
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
872.3750, 872.5410
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
4004-432
GUDID
4004--432
Device ClassEUDAMED
Class IIa
GUDID
Class II

Manufacturer details

EUDAMED SRN
US-MF-000014059
Authorised representative
3M Deutschland GmbH (Orthodontic) DE-AR-000011643

Other devices from Solventum Orthodontics Corporation

See all devices from Solventum Orthodontics Corporation →

Properties

  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (19)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No