Not currently registered with FDA under this name
Bioalpha, Inc.
Seongnam, South Korea. Named as applicant on 1 dental 510(k) clearance between 2009 and 2009. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 12009–2009
- Markets registered in
- 1United States
- Establishments
- 0—
510(k) clearances per year, 2000–2026
510(k) clearances
Clearances on which FDA names Bioalpha, Inc. as the applicant.
Some of these clearances are listed with FDA today by another company: CG Bio Co., Ltd. (1).
Sources
FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record of the most recent filing, which can be a US agent.