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Biocetec Co., Ltd.

Active in EUDAMED

South Koreafrom SRN EUDAMED SRN KR-MF-000045343

Devices
526
Registrations
EUDAMED

What Biocetec Co., Ltd. makes

Biocetec Co., Ltd. manufactures orthodontic ceramic brackets, including the C-Line, S-Line, and A-Line Advanced series, as well as orthodontic mini implants under the Bio-TackS brand. These products are designed for dental alignment and anchorage applications in orthodontic treatment.

The company’s portfolio is regulated under FDA Class II devices and requires 510(k) clearance in the United States. No additional registries or classifications are specified.

AI-generated from registry data, 2 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue526

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  • Bio-Tack Ref NCHH1410

    Active Regimes: CE MDD Registry: EUDAMED Class:IIb
  • Bio-Tack S Ref NBCH1406S

    Active Regimes: CE MDD Registry: EUDAMED Class:IIb
  • Bio-Tack Ref CHC1610

    Active Regimes: CE MDD Registry: EUDAMED Class:IIb
  • S-Line Ref SM22-4300H

    Active Regimes: CE MDD Registry: EUDAMED Class:IIa
  • Bio-Tack Ref BTH1810

    Active Regimes: CE MDD Registry: EUDAMED Class:IIb
  • S-Line Ref SM22-3106

    Active Regimes: CE MDD Registry: EUDAMED Class:IIa
  • Bio-Tack Ref NCHO1408

    Active Regimes: CE MDD Registry: EUDAMED Class:IIb
  • Bio-Tack Ref BSH1806

    Active Regimes: CE MDD Registry: EUDAMED Class:IIb
  • S-Line Ref SR18-3101R

    Active Regimes: CE MDD Registry: EUDAMED Class:IIa
  • S-Line Ref SR22-4522H

    Active Regimes: CE MDD Registry: EUDAMED Class:IIa
  • Bio-Tack S Ref NCHO1406S

    Active Regimes: CE MDD Registry: EUDAMED Class:IIb
  • Bio-Tack S Ref CHH1812S

    Active Regimes: CE MDD Registry: EUDAMED Class:IIb
  • C-Line Ref CR18-4522H

    Active Regimes: CE MDD Registry: EUDAMED Class:IIa
  • Bio-Tack Ref BTH1808

    Active Regimes: CE MDD Registry: EUDAMED Class:IIb
  • C-Line Ref CM22-1210

    Active Regimes: CE MDD Registry: EUDAMED Class:IIa
  • S-Line Ref SR18-4311H

    Active Regimes: CE MDD Registry: EUDAMED Class:IIa
  • Bio-Tack Ref CHO16064

    Active Regimes: CE MDD Registry: EUDAMED Class:IIb
  • Bio-Tack Ref NCHC1604

    Active Regimes: CE MDD Registry: EUDAMED Class:IIb
  • C-Line Ref CR22-3522H

    Active Regimes: CE MDD Registry: EUDAMED Class:IIa
  • Bio-Tack Ref NCHC1812

    Active Regimes: CE MDD Registry: EUDAMED Class:IIb
  • Bio-Tack Ref NCHC1410

    Active Regimes: CE MDD Registry: EUDAMED Class:IIb
  • C-Line Ref CR22-2208

    Active Regimes: CE MDD Registry: EUDAMED Class:IIa
  • C-Line Orthodontic Ceramic Bracket Ref K163467

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • S-Line Ref K182193

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • A-Line Advanced Ref K231635

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Bio-TackS Orthodontic Mini Implant Ref K190871

    Active Regimes: 510(k) Registry: 510(k) Class:II

Rows 501-526 of 526

Showing 501-526 of 526

Company details

EUDAMED SRN
KR-MF-000045343
EUDAMED status
Active
EUDAMED registered name
Biocetec Co., Ltd.
Registered address
108, Gasandigital 2-ro (RM1001-1002 New T Castle), 08506, Seoul, South Korea
Phone
+82 2 704 2876
PRRC contact
Heesue Jin(public in EUDAMED)