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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 16 of 29

  • SAAS30655M Ref SAAS30655M

    Class IIb EUDAMED Active

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    Class IIb EUDAMED Active

  • AO907T Ref AO907T

    Class IIb EUDAMED Active

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    Class IIb EUDAMED Active

  • ASTFA5007S Ref ASTFA5007S

    Class IIb EUDAMED Active

  • FXTR5011RS Ref FXTR5011RS

    Class IIb EUDAMED Active

  • HAA709T Ref HAA709T

    Class IIb EUDAMED Active

  • FXTR6013RS Ref FXTR6013RS

    Class IIb EUDAMED Active

  • SAAS65754 Ref SAAS65754

    Class IIb EUDAMED Active

  • HAA604TM Ref HAA604TM

    Class IIb EUDAMED Active

  • FXTR5018RS Ref FXTR5018RS

    Class IIb EUDAMED Active

  • PXFI3314S Ref PXFI3314S

    Class IIb EUDAMED Active

  • HAA553T Ref HAA553T

    Class IIb EUDAMED Active

  • SAAT50645 Ref SAAT50645

    Class IIb EUDAMED Active

  • SAAS30565M Ref SAAS30565M

    Class IIb EUDAMED Active

  • PXFI3312S Ref PXFI3312S

    Class IIb EUDAMED Active

  • SAAS50647 Ref SAAS50647

    Class IIb EUDAMED Active

  • SAAT30535MN Ref SAAT30535MN

    Class IIb EUDAMED Active

  • SAAT30517MN Ref SAAT30517MN

    Class IIb EUDAMED Active

  • Tibs-011M Ref Tibs-011M

    Class IIb EUDAMED Active

  • ASTFA3513S Ref ASTFA3513S

    Class IIb EUDAMED Active

  • PXFI4108NS Ref PXFI4108NS

    Class IIb EUDAMED Active

  • PXFI3308NS Ref PXFI3308NS

    Class IIb EUDAMED Active

  • OAO557M Ref OAO557M

    Class IIb EUDAMED Active

  • FXAR3410TS Ref FXAR3410TS

    Class IIb EUDAMED Active

  • ABHS1608 Ref ABHS1608

    Class IIb EUDAMED Active

  • FXIR4007MS Ref FXIR4007MS

    Class IIb EUDAMED Active

  • SAAS30635M Ref SAAS30635M

    Class IIb EUDAMED Active

  • FXAR4508TS Ref FXAR4508TS

    Class IIb EUDAMED Active

  • SAAS3454M Ref SAAS3454M

    Class IIb EUDAMED Active

  • FXBR4008RS Ref FXBR4008RS

    Class IIb EUDAMED Active

  • SAAS55654 Ref SAAS55654

    Class IIb EUDAMED Active

  • FXBR5008TS Ref FXBR5008TS

    Class IIb EUDAMED Active

  • SIC6005W Ref SIC6005W

    Class IIb EUDAMED Active

  • PXFI4110NS Ref PXFI4110NS

    Class IIb EUDAMED Active

  • SAAS30524M Ref SAAS30524M

    Class IIb EUDAMED Active

  • PXFI4814WS Ref PXFI4814WS

    Class IIb EUDAMED Active

  • FXAR4511TS Ref FXAR4511TS

    Class IIb EUDAMED Active

  • SABS4540M Ref SABS4540M

    Class IIb EUDAMED Active

  • HAA405S Ref HAA405S

    Class IIb EUDAMED Active

  • SAAS50645 Ref SAAS50645

    Class IIb EUDAMED Active

  • HAA604T Ref HAA604T

    Class IIb EUDAMED Active

  • SAAT50625N Ref SAAT50625N

    Class IIb EUDAMED Active

  • BS4 Ref BS4

    Class IIb EUDAMED Active

  • HAA452T Ref HAA452T

    Class IIb EUDAMED Active

  • MAA452M Ref MAA452M

    Class IIb EUDAMED Active

  • ASTFA4510S Ref ASTFA4510S

    Class IIb EUDAMED Active

  • SAAT45557 Ref SAAT45557

    Class IIb EUDAMED Active

  • SAAT30524MN Ref SAAT30524MN

    Class IIb EUDAMED Active

  • FXIR4815S Ref FXIR4815S

    Class IIb EUDAMED Active

Showing 751-800 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