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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 15 of 29

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    Class IIb EUDAMED Active

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Showing 701-750 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