Not currently registered with FDA under this name
Byron Medical
Tucson, AZ, United States. Named as applicant on 1 dental 510(k) clearance between 1994 and 1994. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 11994–1994
- Markets registered in
- 760 registrations outside the US
- Establishments
- 0—
510(k) clearances per year, 1990–2026
Registered in 7 markets
Where regulators' registries name Byron Medical as the manufacturer or the registration holder of a device.
RegisteredHome: United StatesOne marker per market
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Applicant | Byron Medical | 1 clearances | 1994–1994 | Below |
| Canada | Health Canada | Registration holder | BYRON MEDICAL INC. | 44 | 2005–2006 | Pure Global AI |
| South Korea | MFDS | Manufacturer | Byron Medical, Inc.Byron Medical, Inc · Byron Medical | 7 | 2001–2008 | Pure Global AI |
| Australia | TGA | Registration holder | Byron Medical Pty Ltd | 6 | 2021–2026 | Pure Global AI |
| Colombia | INVIMA | Manufacturer | BYRON MEDICAL INC | 1 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | BYRON MEDICAL | 1 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | BYRON MEDICAL | 1 | 2007–2007 | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
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.