Biotem Co., ltd

South Korea Last updated 22 Oct 2026

Devices: 1,418
Registries: EUDAMEDGUDIDFDA 510(k)FDA
FDA recalls: 0

Catalogue1,418

Page 29 of 29

Biotem SAAT55625N Ref SAAT55625N

Class II EUDAMEDFDA UDI Active
Biotem STFA5008 Ref STFA5008

Class II FDA UDI Active
Biotem HAB50603 Ref HAB50603

Class II EUDAMEDFDA UDI Active
Biotem CSB3501 Ref CSB3501

Class II EUDAMEDFDA UDI Active
Biotem SAAS65724 Ref SAAS65724

Class II EUDAMEDFDA UDI Active
Biotem SAAT65727 Ref SAAT65727

Class II EUDAMEDFDA UDI Active
Biotem SABT50635 Ref SABT50635

Class II EUDAMEDFDA UDI Active
Biotem TD42 Ref TD42

Class I FDA UDI Active
Biotem SAAT45524N Ref SAAT45524N

Class II EUDAMEDFDA UDI Active
Bone Cup BPC10D20 Ref BPC10D20

Class I FDA UDI Active
Biotem Bone Pen Air Kit BPAK Ref BPAK

Class I FDA UDI Active
Bone Pin BPP10D20 Ref BPP10D20

Class I FDA UDI Active
IR Type Implant System Ref K171185

Class II FDA 510(k) Active
AR_N Type Implant System Ref K171297

Class II FDA 510(k) Active
BR Type Implant System Ref K171179

Class II FDA 510(k) Active
BR SLA Type Implant System Ref K222142

Class II FDA 510(k) Active
AR_N SLA Type Implant System Ref K190641

Class II FDA 510(k) Active
IR SLA Type Implant System Ref K222144

Class II FDA 510(k) Active

Showing 1,401-1,418 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
Email: [email protected]
PRRC contact: Chang Kyu Hwang
EUDAMED SRN: KR-MF-000040891
DUNS number: 557793214

Catalogue1,418

Biotem SAAT55625N Ref SAAT55625N

Biotem STFA5008 Ref STFA5008

Biotem HAB50603 Ref HAB50603

Biotem CSB3501 Ref CSB3501

Biotem SAAS65724 Ref SAAS65724

Biotem SAAT65727 Ref SAAT65727

Biotem SABT50635 Ref SABT50635

Biotem TD42 Ref TD42

Biotem SAAT45524N Ref SAAT45524N

Bone Cup BPC10D20 Ref BPC10D20

Biotem Bone Pen Air Kit BPAK Ref BPAK

Bone Pin BPP10D20 Ref BPP10D20

IR Type Implant System Ref K171185

AR_N Type Implant System Ref K171297

BR Type Implant System Ref K171179

BR SLA Type Implant System Ref K222142

AR_N SLA Type Implant System Ref K190641

IR SLA Type Implant System Ref K222144

FDA establishments1

What Biotem Co., ltd makes

Information