Not currently registered with FDA under this name
Isotis NV
Bilthoven, Netherlands. Named as applicant on 3 dental 510(k) clearances between 2004 and 2006. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 32004–2006
- Markets registered in
- 21 registrations outside the US
- Establishments
- 0—
510(k) clearances per year, 2000–2026
Registered in 2 markets
Where regulators' registries name Isotis NV 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 | Isotis NV | 3 clearances | 2004–2006 | Below |
| South Korea | MFDS | Manufacturer | ISOTIS NV | 1 | 2005–2005 | 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 Isotis NV as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 29 Mar 2006 | K060332 | ORTHOBLAST II DBM DEMINERALIZED BONE MATRIX PASTE AND PUTTY | NUN Human Source Bone Grafting Material |
| 27 Mar 2006 | K060306 | ACCELL CONNEXUS DEMINERALIZED BONE MATRIX PUTTY | NUN Human Source Bone Grafting Material |
| 20 Aug 2004 | K031813 | OSSATURA DENTAL | LYC Synthetic Bone Grafting Material |
Some of these clearances are listed with FDA today by another company: Keystone Dental Inc. (2), SeaSpine Orthopedics Corporation (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.