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Osstem Orthodontics Inc.

Active in EUDAMED

South Koreafrom SRN EUDAMED FDA SRN KR-MF-000021559 FEI 3006946041

Osstem Orthodontics Inc. is a medical device manufacturer based in South Korea, with 721 devices listed in EUDAMED (EU Class IIa and I) as of 12 Nov 2026.

Devices
721
Registrations
EUDAMEDFDA
FDA recalls
0

Registry facts

Counted by deviCERTS from registry records, 12 Nov 2026

Registries
  • EUDAMED 721
Device classes
  • EU Class IIa 715
  • EU Class I 6
Top EMDN categories
Sites and related companies
Identifiers
  • EUDAMED SRN KR-MF-000021559
  • FDA FEI 3006946041

At a glance

Counted by deviCERTS from registry records

Market reach

European Union
EUDAMED actor
United States
FDA FEI
Authorised rep.
AR Experts B.V.NL

What Osstem Orthodontics Inc. makes

Osstem Orthodontics Inc. manufactures orthodontic tubes, including adhesive brackets, wax, and resin brackets designed for dental alignment treatments. Their product line includes bonded brackets (e.g., OK REAL RESIN BRACKET), self-ligating tubes (e.g., SM TUBE), and orthodontic wax (e.g., ANAPER WAX). Some devices are tailored for aesthetic purposes, such as clear brackets (e.g., PERFECT CLEAR II). The company also produces metal-free self-ligating systems (e.g., MAJESTY-SLM) for reduced friction in braces.

Orthodontic tubes and brackets from Osstem Orthodontics Inc. are classified as Class I or Class IIa under EU regulations, with relevant devices listed in the EU’s eudamed database. The company is based in South Korea. No other regulatory registries or jurisdictions are specified for these products.

AI-generated from registry data, 3 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue721

Newest first, rows 1-50 of 721

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  • Anaper Wax Ref 801-20

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Perfect Ref 712-11-10

    Withdrawn Regimes: CE MDD, withdrawn Registry: EUDAMED Class:IIa

  • Perfect Clear Ref 340-551K

    Withdrawn Regimes: CE MDD, withdrawn Registry: EUDAMED Class:IIa

  • Sm Tube Ref 575-47-10

    Withdrawn Regimes: CE MDD, withdrawn Registry: EUDAMED Class:IIa

  • Perfect Clear Ii Ref 220-503

    Active Regimes: CE MDD Registry: EUDAMED Class:IIa

  • Sm Tube Ref 501-36-10

    Withdrawn Regimes: CE MDD, withdrawn Registry: EUDAMED Class:IIa

  • Majesty-Slm Ref 107-14H-5

    Withdrawn Regimes: CE MDD, withdrawn Registry: EUDAMED Class:IIa

  • Sm Tube Ref 565-27-10

    Withdrawn Regimes: CE MDD, withdrawn Registry: EUDAMED Class:IIa

  • Sm Tube Ref 531-37-10

    Withdrawn Regimes: CE MDD, withdrawn Registry: EUDAMED Class:IIa

  • Ok Real Resin Bracket Ref 650-13H-5

    Active Regimes: CE MDD Registry: EUDAMED Class:IIa

  • Majesty-Slc Ref M-100-33H-5

    Withdrawn Regimes: CE MDD, withdrawn Registry: EUDAMED Class:IIa

  • Perfect Ref 703-21-10

    Active Regimes: CE MDD Registry: EUDAMED Class:IIa

  • Ok Real Resin Bracket Ref 620-43H-5

    Withdrawn Regimes: CE MDD, withdrawn Registry: EUDAMED Class:IIa

  • Perfect Clear Ref 330-300

    Withdrawn Regimes: CE MDD, withdrawn Registry: EUDAMED Class:IIa

  • Perfect Clear Ii Ref 220-331

    Active Regimes: CE MDD Registry: EUDAMED Class:IIa

  • Majesty-Slm Ref 117-031

    Withdrawn Regimes: CE MDD, withdrawn Registry: EUDAMED Class:IIa

  • Perfect Clear Ii Ref 220-21-5

    Withdrawn Regimes: CE MDD, withdrawn Registry: EUDAMED Class:IIa

  • Sm Tube Ref 512-26-10

    Active Regimes: CE MDD Registry: EUDAMED Class:IIa

  • Perfect Clear Ref 320-053A

    Withdrawn Regimes: CE MDD, withdrawn Registry: EUDAMED Class:IIa

  • Perfect Clear Ref 330-553

    Active Regimes: CE MDD Registry: EUDAMED Class:IIa

  • Perfect Clear Ii Ref 200-14-5

    Active Regimes: CE MDD Registry: EUDAMED Class:IIa

  • Perfect Clear Ii Ref 250-11-5

    Withdrawn Regimes: CE MDD, withdrawn Registry: EUDAMED Class:IIa

  • Sm Tube Ref 511-27-10

    Withdrawn Regimes: CE MDD, withdrawn Registry: EUDAMED Class:IIa

  • Perfect Clear Ref 350-31-5

    Active Regimes: CE MDD Registry: EUDAMED Class:IIa

  • Perfect Clear Ref 310-030

    Withdrawn Regimes: CE MDD, withdrawn Registry: EUDAMED Class:IIa

  • Perfect Clear Ref 340-33-5

    Withdrawn Regimes: CE MDD, withdrawn Registry: EUDAMED Class:IIa

  • Perfect Clear Ref 320-11-5

    Active Regimes: CE MDD Registry: EUDAMED Class:IIa

  • Ok Real Resin Bracket Ref 630-31-5

    Active Regimes: CE MDD Registry: EUDAMED Class:IIa

  • Perfect Clear Ref 300-21-5

    Active Regimes: CE MDD Registry: EUDAMED Class:IIa

  • Ok Real Resin Bracket Ref 610-43H-5

    Active Regimes: CE MDD Registry: EUDAMED Class:IIa

  • Perfect Clear Ii Ref 220-32-5

    Withdrawn Regimes: CE MDD, withdrawn Registry: EUDAMED Class:IIa

  • Majesty-Slc Ref M-110-31-5

    Active Regimes: CE MDD Registry: EUDAMED Class:IIa

  • Perfect Clear Ref 320-550A

    Withdrawn Regimes: CE MDD, withdrawn Registry: EUDAMED Class:IIa

  • Ok Real Resin Bracket Ref 690-35H-5

    Active Regimes: CE MDD Registry: EUDAMED Class:IIa

  • Perfect Clear Ii Ref 210-44H-5

    Withdrawn Regimes: CE MDD, withdrawn Registry: EUDAMED Class:IIa

  • Ok Real Resin Bracket Ref 640-301

    Withdrawn Regimes: CE MDD, withdrawn Registry: EUDAMED Class:IIa

  • Perfect Clear Ii Ref 210-14H-5

    Active Regimes: CE MDD Registry: EUDAMED Class:IIa

  • Ok Real Resin Bracket Ref 610-11-5

    Active Regimes: CE MDD Registry: EUDAMED Class:IIa

  • Perfect Clear Ii Ref 240-031T

    Withdrawn Regimes: CE MDD, withdrawn Registry: EUDAMED Class:IIa

  • Sm Tube Ref 560-47-10

    Withdrawn Regimes: CE MDD, withdrawn Registry: EUDAMED Class:IIa

  • Perfect Clear Ref 330-14H-5

    Active Regimes: CE MDD Registry: EUDAMED Class:IIa

  • Ok Real Resin Bracket Ref 600-34-5

    Active Regimes: CE MDD Registry: EUDAMED Class:IIa

  • Sm Tube Ref 530-200

    Withdrawn Regimes: CE MDD, withdrawn Registry: EUDAMED Class:IIa

  • Perfect Clear Ref 350-500

    Withdrawn Regimes: CE MDD, withdrawn Registry: EUDAMED Class:IIa

  • Perfect Clear Ref 350-330

    Withdrawn Regimes: CE MDD, withdrawn Registry: EUDAMED Class:IIa

  • Ok Real Resin Bracket Ref 600-43H-5

    Active Regimes: CE MDD Registry: EUDAMED Class:IIa

  • Perfect Clear Ii Ref 200-23-5

    Withdrawn Regimes: CE MDD, withdrawn Registry: EUDAMED Class:IIa

  • Perfect Clear Ref 320-330K

    Withdrawn Regimes: CE MDD, withdrawn Registry: EUDAMED Class:IIa

  • Sm Tube Ref 503-26-10

    Active Regimes: CE MDD Registry: EUDAMED Class:IIa

  • Perfect Clear Ii Ref 200-33H-5

    Active Regimes: CE MDD Registry: EUDAMED Class:IIa

Rows 1-50 of 721

Showing 1-50 of 721

Company details

EUDAMED record synced 7 Nov 2026

EUDAMED SRN
KR-MF-000021559
FDA FEI number
3006946041
EU VAT number
135-81-76877
EUDAMED status
Active
EUDAMED registered name
Osstem Orthodontics Inc.
Registered address
13, Ojeongongeop-gil, 16072, Uiwang-si, South Korea
Phone
+82 31 477 9902
PRRC contact
Beom Seok Seo(public in EUDAMED)

Frequently asked questions

How many devices does Osstem Orthodontics Inc. have in the registry?

The registry currently lists 721 devices for Osstem Orthodontics Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Osstem Orthodontics Inc.'s devices?

Among its 50 most recently registered devices, Osstem Orthodontics Inc. has devices listed in EUDAMED (50 devices).

What risk classes do Osstem Orthodontics Inc.'s devices fall under?

Among its 50 most recently registered devices, the classes recorded for Osstem Orthodontics Inc.'s devices are Class I and Class IIa. Each device page shows its own class and authorisation.

What are the newest devices from Osstem Orthodontics Inc. in the registry?

The most recently registered devices listed for Osstem Orthodontics Inc. include ANAPER WAX, PERFECT, PERFECT CLEAR and SM TUBE.

Generated automatically from registry data and not verified by a human reviewer.