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Fastbraces® CLASSIC Clear Bracket Kit

by Orthoworld LLC

Ref 99K-345-22-01

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

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 22 Oct 2026

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/MDR EUDAMED Number850048985BRACKETS55 Basic UDI-DI 00850048985049UDI-DIDate24 Jul 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number00850048985049 UDI-DI Date14 May 2024ListedStatusListed 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.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

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  • Withdrawn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

Generic Name
Orthodontic bracket, ceramic
Device Name
Orthodontic Brackets
Model / Ref / Catalog
99K-345-22-01, Clear Bracket Kit
Primary DI / UDI-DI
00850048985049
Basic UDI-DI
850048985BRACKETS55
510(k) Number
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 · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
99K-345-22-01
GUDID
Clear Bracket Kit
Device ClassEUDAMED
Class IIa
GUDID
Class II

Manufacturer details

EUDAMED SRN
US-MF-000037185
Authorised representative
MDSS GmbH DE-AR-000005430

Related devices

Category: Orthodontic tube

Other devices from Orthoworld LLC

See all devices from Orthoworld LLC →

Properties

  • Single Use
  • Prescription Use
  • Convenience Kit
  • Lot / Batch Number
  • 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
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No