Not currently registered with FDA under this name
Etex Corp.
Cambridge, MA, United States. Named as applicant on 5 dental 510(k) clearances between 1992 and 2010. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 51992–2010
- Markets registered in
- 46 registrations outside the US
- Establishments
- 0—
510(k) clearances per year, 1990–2026
Registered in 4 markets
Where regulators' registries name Etex Corp. 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 | Etex Corp. | 5 clearances | 1992–2010 | Below |
| Brazil | ANVISA | Manufacturer | ETEX CORPORATION | 4 | 2017–2021 | Pure Global AI |
| Israel | AMAR | Manufacturer | ETEX Corporation | 1 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | ETEX Corporation | 1 | 2017–2017 | 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 Etex Corp. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 21 Dec 2010 | K100883 | CARRIGEN | LYC Synthetic Bone Grafting Material |
| 3 Dec 2010 | K102812 | GAMMA-BSM; BETA-BSM; EQUIVABONE | LYC Synthetic Bone Grafting Material |
| 23 Dec 2009 | K091729 | ALPHA-BSM, BETA-BSM, GAMMA-BSM, EQUIVABONE | LYC Synthetic Bone Grafting Material |
| 5 Aug 1997 | K962548 | BSM BONE SUBSTITUTE MATERIAL KIT | LYC Synthetic Bone Grafting Material |
| 19 Feb 1992 | K913417 | ETEX DENTAL IMPLANT SYSTEM | DZE Root-Form Endosseous Implant |
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.