Medical Device Manufacturer · KR , Busan

Biotem Co., Ltd. - FDA 510(k) Cleared Devices

6 submissions · 6 cleared · Since 2017

Total

Cleared

Denied

Biotem Co., Ltd. has 6 FDA 510(k) cleared medical devices. Based in Busan, KR.

Last cleared in 2023. Active since 2017. Primary specialty: Dental.

Browse the FDA 510(k) cleared devices submitted by Biotem Co., Ltd. Filter by specialty or product code using the sidebar.

510(k) submissions have been managed by Provision Consulting Group, Inc. as regulatory consultant.

Biotem Co., Ltd. is one of 351 FDA 510(k) medical device manufacturers from South Korea in the dataset, ranked by real submission volume.

FDA 510(k) Regulatory Record - Biotem Co., Ltd.

6 devices

1-6 of 6

Data Source

Sourced from the FDA 510(k) public files . 175,450 total devices indexed.

Last updated: May 14, 2026