Medical Device Manufacturer · US , Laguna Niguel , CA

Biotech One, Inc. - FDA 510(k) Cleared Devices

2 submissions · 2 cleared · Since 2004

Recent clearances: KORLEX-GR GINGIVAL RETRACTION PASTE, BONAMATES SERIES

View 2 510(k) Devices ↓

2

Total

2

Cleared

0

Denied

FDA 510(k) Regulatory Record - Biotech One, Inc. Dental ✕

2 devices

1-2 of 2

Cleared Feb 15, 2006

KORLEX-GR GINGIVAL RETRACTION PASTE

Cleared Jun 03, 2004

BONAMATES SERIES

Data Source

Sourced from the FDA 510(k) public files . 176,325 total devices indexed.

Last updated: Sep 27, 2026