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Ok Real Resin Bracket

by Osstem Orthodontics Inc. 122 variants

Ref 640-301Model 640-301 OK BRACKET STD 018

Ok Real Resin Bracket (640-301) is a Class IIa device made by Osstem Orthodontics Inc., registered in EUDAMED on 17 Jul 2024 (Basic UDI-DI B-08800033403883), withdrawn as of 22 Oct 2026.

Withdrawn Withdrawn in European Union.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Was authorized under CE MDD, withdrawn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Withdrawn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

Source EUDAMED, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-08800033403883 Basic UDI-DI 08800033403883UDI-DIDate17 Jul 2024RegisteredStatusWithdrawn No longer placed on the EU market

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDD Withdrawn

Specification

EUDAMED

Model / reference
640-301 OK BRACKET STD 018, 640-301
Primary DI / UDI-DI
08800033403883
Basic UDI-DI
B-08800033403883
EMDN code
Q010403 Orthodontic brackets and buttons
Device class
Class IIa
EU registration type
Legacy device (under a directive)

Manufacturer details

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

Related devices

Category: Orthodontic tube

Similar devices in this category

Other devices filed under ORTHODONTIC BRACKETS AND BUTTONS.

Other devices from Osstem Orthodontics Inc.

See all devices from Osstem Orthodontics Inc. →

Properties

Other properties (12, all answered No)