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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 17 of 29

  • BAAS4802 Ref BAAS4802

    Class IIb EUDAMED Active

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    Class IIb EUDAMED Active

  • ASTFA6007S Ref ASTFA6007S

    Class IIb EUDAMED Active

  • FXAR5010TS Ref FXAR5010TS

    Class IIb EUDAMED Active

  • HAA607TM Ref HAA607TM

    Class IIb EUDAMED Active

  • SAAS30624M Ref SAAS30624M

    Class IIb EUDAMED Active

  • AO553M Ref AO553M

    Class IIb EUDAMED Active

  • ABHS2508 Ref ABHS2508

    Class IIb EUDAMED Active

  • MAA553 Ref MAA553

    Class IIb EUDAMED Active

  • SAAS3434M Ref SAAS3434M

    Class IIb EUDAMED Active

  • HAA605T Ref HAA605T

    Class IIb EUDAMED Active

  • HAA403S Ref HAA403S

    Class IIb EUDAMED Active

  • ASTFA4515S Ref ASTFA4515S

    Class IIb EUDAMED Active

  • PXFI3308S Ref PXFI3308S

    Class IIb EUDAMED Active

  • HAP5808 Ref HAP5808

    Class IIb EUDAMED Active

  • SAAS3424M Ref SAAS3424M

    Class IIb EUDAMED Active

  • AO819T Ref AO819T

    Class IIb EUDAMED Active

  • FXBR4010TS Ref FXBR4010TS

    Class IIb EUDAMED Active

  • HAI35506 Ref HAI35506

    Class IIb EUDAMED Active

  • HAA48235 Ref HAA48235

    Class IIb EUDAMED Active

  • FXBR4515TS Ref FXBR4515TS

    Class IIb EUDAMED Active

  • AOHS2008 Ref AOHS2008

    Class IIb EUDAMED Active

  • SAAS40525 Ref SAAS40525

    Class IIb EUDAMED Active

  • HAI555 Ref HAI555

    Class IIb EUDAMED Active

  • FXIR4807S Ref FXIR4807S

    Class IIb EUDAMED Active

  • HAA58235 Ref HAA58235

    Class IIb EUDAMED Active

  • FXIR4813MS Ref FXIR4813MS

    Class IIb EUDAMED Active

  • FXIR4807MS Ref FXIR4807MS

    Class IIb EUDAMED Active

  • SAAS40535 Ref SAAS40535

    Class IIb EUDAMED Active

  • SAAS30625M Ref SAAS30625M

    Class IIb EUDAMED Active

  • MAA652 Ref MAA652

    Class IIb EUDAMED Active

  • HAA552M Ref HAA552M

    Class IIb EUDAMED Active

  • HAA409S Ref HAA409S

    Class IIb EUDAMED Active

  • HCA4504 Ref HCA4504

    Class IIb EUDAMED Active

  • FXBR6013RSS Ref FXBR6013RSS

    Class IIb EUDAMED Active

  • FXAR3715TS Ref FXAR3715TS

    Class IIb EUDAMED Active

  • HAA659S Ref HAA659S

    Class IIb EUDAMED Active

  • FXBR6008RSA Ref FXBR6008RSA

    Class IIb EUDAMED Active

  • SAAT50627 Ref SAAT50627

    Class IIb EUDAMED Active

  • BAAS4804 Ref BAAS4804

    Class IIb EUDAMED Active

  • FXBR3315TS Ref FXBR3315TS

    Class IIb EUDAMED Active

  • SAAT30515MN Ref SAAT30515MN

    Class IIb EUDAMED Active

  • FXBR3713TS Ref FXBR3713TS

    Class IIb EUDAMED Active

  • FXBR3710RS Ref FXBR3710RS

    Class IIb EUDAMED Active

  • SAAT30514MN Ref SAAT30514MN

    Class IIb EUDAMED Active

  • SAAT30644M Ref SAAT30644M

    Class IIb EUDAMED Active

  • HAA505TM Ref HAA505TM

    Class IIb EUDAMED Active

  • SAAS3435M Ref SAAS3435M

    Class IIb EUDAMED Active

  • FXTR5015TS Ref FXTR5015TS

    Class IIb EUDAMED Active

  • HAI35501 Ref HAI35501

    Class IIb EUDAMED Active

Showing 801-850 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