Not currently registered with FDA under this name
Biomatlante
Vigneux De Bretagne, France. Named as applicant on 3 dental 510(k) clearances between 2005 and 2010. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 32005–2010
- Markets registered in
- 955 registrations outside the US
- Establishments
- 0—
510(k) clearances per year, 2000–2026
Registered in 9 markets
Where regulators' registries name Biomatlante as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Applicant | Biomatlante | 3 clearances | 2005–2010 | Below |
| Colombia | INVIMA | Manufacturer | BIOMATLANTEBIOMATLANTE S.A.S · BIOMATLANTE SA | 14 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | BIOMATLANTEBiomatlante SA | 12 | 2002–2015 | Pure Global AI |
| South Korea | MFDS | Manufacturer | BiomatlanteBIOMATLANTE · Biomatlante SA | 8 | 2002–2022 | Pure Global AI |
| Australia | TGA | Manufacturer | Biomatlante SA | 7 | 2007–2026 | Pure Global AI |
| Israel | AMAR | Manufacturer | BiomatlanteBiomatlante SA | 6 | — | Pure Global AI |
| Peru | DIGEMID | Manufacturer | BIOMATLANTEBIOMATLANTE SA | 4 | 2015–2021 | Pure Global AI |
| Egypt | EDA | Manufacturer | Biomatlante SA,Biomatlante sa, | 2 | 2025–2025 | Pure Global AI |
| Hong Kong | MDD | Manufacturer | Biomatlante SA | 2 | 2026–2026 | 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
510(k) clearances
Clearances on which FDA names Biomatlante as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 15 Mar 2010 | K093122 | MBCP+ | LYC Synthetic Bone Grafting Material |
| 2 Jun 2006 | K060732 | MBCP GEL | LYC Synthetic Bone Grafting Material |
| 16 Sep 2005 | K051885 | MBCP | LYC Synthetic Bone Grafting Material |
Some of these clearances are listed with FDA today by another company: Advanced Medical Solutions Group PLC (3), Young Innovations Inc (1), Dentsply Sirona, Inc. (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.