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Ok Real Resin Bracket

EUDAMED

Class IIa (EU MDR)

Ref 670-33H-5Model 670-33H OK ROTH 022 #33H

by Osstem Orthodontics Inc.

Identity

Trade Name: OK REAL RESIN BRACKET EUDAMED
Model / Reference: 670-33H OK ROTH 022 #33H EUDAMED
670-33H-5 EUDAMED

Identifiers

Primary DI / UDI-DI: 08800033466291 EUDAMED
Basic UDI-DI: B-08800033466291 EUDAMED
EMDN Code: Q010403 ORTHODONTIC BRACKETS AND BUTTONS EUDAMED

Classification

Device Class: Class IIa EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Implantable

No

EUDAMED

Reusable

No

EUDAMED

Contains Latex

No

EUDAMED

Reprocessed

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Category: Orthodontic tube

Ok Real Resin Bracket by Osstem Orthodontics Inc. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS

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Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDD

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Manufacturer

Manufacturer: Osstem Orthodontics Inc.
EUDAMED SRN: KR-MF-000021559
Authorised Representative: AR Experts B.V. NL-AR-000023989

Sources (1)

EUDAMED 6304b797-b0c5-4d46-84f8-f0abf1ff12db 61 fields · synced Jun 18, 2026