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Ok Real Resin Bracket

by Osstem Orthodontics Inc. 122 variants

Ref 620-503Model 620-503 OK BRACKET MBT 018

Withdrawn Withdrawn in European Union. No longer placed on the EU market.

Was authorized under CE MDD, withdrawn

Ended

Withdrawn

Date not published (CE MDD)

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-08800033403784 Basic UDI-DI 08800033403784UDI-DIDate17 Jul 2024RegisteredStatusWithdrawn No longer placed on the EU market

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

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDD Withdrawn

Specification

EUDAMED

Model / Reference
620-503 OK BRACKET MBT 018, 620-503
Primary DI / UDI-DI
08800033403784
Basic UDI-DI
B-08800033403784
EMDN Code
Q010403 Orthodontic brackets and buttons
Device Class
Class IIa

Manufacturer details

EUDAMED SRN
KR-MF-000021559
Authorised representative
AR Experts B.V. NL-AR-000023989

Related devices

Category: Orthodontic tube

Other devices from Osstem Orthodontics Inc.

See all devices from Osstem Orthodontics Inc. →

Properties

Other properties (11)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No