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Clarity™ APC™ MBT™

by Solventum Orthodontics Corporation 11 variants

Ref 003-358

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

CE MDR

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number00197998366871 UDI-DI Date6 Aug 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number01979988401020000000105NH Basic UDI-DI 00197998366871UDI-DIDate19 Jun 2026RegisteredStatusActive

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  • Withdrawn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/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Clarity™ APC™ MBT™ EUDAMED
Clarity™ GUDID
Generic Name
Orthodontic bracket, ceramic
Device Name
Clarity™ Ultra Self-Ligating Ceramic Brakcets
Model / Ref / Catalog
003-358
Primary DI / UDI-DI
00197998366871
Basic UDI-DI
01979988401020000000105NH
Unit of Use DI
00197998105913
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 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

Manufacturer details

EUDAMED SRN
US-MF-000014059
Authorised representative
Solventum Germany GmbH DE-AR-000043541

Other devices from Solventum Orthodontics Corporation

See all devices from Solventum Orthodontics Corporation →

Properties

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

Other properties (20)

  • 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
  • Expiration Date: No