Not currently registered with FDA under this name
Graftys
Aix En Provence, France. 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
- 925 registrations outside the US
- Establishments
- 0—
510(k) clearances per year, 2000–2026
Registered in 9 markets
Where regulators' registries name Graftys as the manufacturer or the registration holder of a device.
RegisteredHome: FranceOne marker per market
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Applicant | Graftys | 1 clearances | 2009–2009 | Below |
| Colombia | INVIMA | Manufacturer | GRAFTYS | 9 | — | Pure Global AI |
| European Union | EUDAMED | Manufacturer | Graftys | 4 | — | Pure Global AI |
| Canada | Health Canada | Registration holder | GRAFTYS | 3 | 2014–2016 | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | GRAFTYS | 3 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | GRAFTYS | 3 | 2009–2009 | Pure Global AI |
| Australia | TGA | Manufacturer | Graftys | 1 | 2016–2016 | Pure Global AI |
| Israel | AMAR | Manufacturer | GRAFTYS | 1 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | GRAFTYS | 1 | 2011–2011 | 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.