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Biotem Co., ltd

South Korea Last updated 22 Oct 2026

Devices
1,418
Registries
EUDAMEDFDA
FDA recalls
0

Catalogue1,418

Page 13 of 29

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    Class IIb EUDAMED Active

  • SAAT50625 Ref SAAT50625

    Class IIb EUDAMED Active

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    Class IIb EUDAMED Active

  • FXBR3318RS Ref FXBR3318RS

    Class IIb EUDAMED Active

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    Class IIb EUDAMED Active

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    Class IIb EUDAMED Active

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    Class IIb EUDAMED Active

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    Class IIb EUDAMED Active

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    Class IIb EUDAMED Active

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    Class IIb EUDAMED Active

  • SAAS4044 Ref SAAS4044

    Class IIb EUDAMED Active

  • PXFI4806S Ref PXFI4806S

    Class IIb EUDAMED Active

  • FXBR3715RS Ref FXBR3715RS

    Class IIb EUDAMED Active

  • SAAT30644MN Ref SAAT30644MN

    Class IIb EUDAMED Active

  • BAIS4802 Ref BAIS4802

    Class IIb EUDAMED Active

  • FXIR4007S Ref FXIR4007S

    Class IIb EUDAMED Active

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    Class IIb EUDAMED Active

  • APHS1807 Ref APHS1807

    Class IIb EUDAMED Active

  • SAAS50624 Ref SAAS50624

    Class IIb EUDAMED Active

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    Class IIb EUDAMED Active

  • HAA509T Ref HAA509T

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  • SAAT50617 Ref SAAT50617

    Class IIb EUDAMED Active

  • HAB41603 Ref HAB41603

    Class IIb EUDAMED Active

  • SAAS50617 Ref SAAS50617

    Class IIb EUDAMED Active

  • FXBR3308RS Ref FXBR3308RS

    Class IIb EUDAMED Active

  • HAA504TM Ref HAA504TM

    Class IIb EUDAMED Active

  • FXAR4007TS Ref FXAR4007TS

    Class IIb EUDAMED Active

  • HAA609TM Ref HAA609TM

    Class IIb EUDAMED Active

  • HAA58350 Ref HAA58350

    Class IIb EUDAMED Active

  • FXBR4511RS Ref FXBR4511RS

    Class IIb EUDAMED Active

  • FXBR3710TS Ref FXBR3710TS

    Class IIb EUDAMED Active

  • SATA4010N Ref SATA4010N

    Class IIb EUDAMED Active

  • ASTFA5015S Ref ASTFA5015S

    Class IIb EUDAMED Active

  • SAAT50637 Ref SAAT50637

    Class IIb EUDAMED Active

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    Class IIb EUDAMED Active

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    Class IIb EUDAMED Active

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    Class IIb EUDAMED Active

  • FXBR6010TSA Ref FXBR6010TSA

    Class IIb EUDAMED Active

  • HCA4507 Ref HCA4507

    Class IIb EUDAMED Active

  • SAAS30654M Ref SAAS30654M

    Class IIb EUDAMED Active

  • AAHS2008B Ref AAHS2008B

    Class IIb EUDAMED Active

  • SAAS45567 Ref SAAS45567

    Class IIb EUDAMED Active

  • AO909T Ref AO909T

    Class IIb EUDAMED Active

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    Class IIb EUDAMED Active

  • SAAT50614 Ref SAAT50614

    Class IIb EUDAMED Active

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    Class IIb EUDAMED Active

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    Class IIb EUDAMED Active

  • SIC6004W Ref SIC6004W

    Class IIb EUDAMED Active

Showing 601-650 of 1,418

FDA establishments1

Registered with the FDA under this company group, matched by name.

  • Biotem Co., Ltd. Busan · KR FEI 3009611645

What Biotem Co., ltd makes

Biotem Co., Ltd manufactures dental implant systems, including components designed for osseointegration in oral and maxillofacial applications. Their portfolio also includes bone pins, which are used for internal fixation in surgical procedures. The devices are intended for use in dental and orthopedic settings, supporting structural stability and integration with bone tissue.

The company’s products are regulated under the FDA’s classification system, with devices falling into Class I and Class II categories. These are listed in the FDA’s Unique Device Identifier (UDI) database, ensuring traceability and compliance with U.S. medical device regulations. The manufacturer operates from the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Information

Address
422, Sasang-ro, Busan, South Korea
Website
naver.com
PRRC contact
Chang Kyu Hwang
EUDAMED SRN
KR-MF-000040891
DUNS number
557793214