Not currently registered with FDA under this name
Dentalpoint AG
Dundas, Canada. Named as applicant on 4 dental 510(k) clearances between 2014 and 2018. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 42014–2018
- Markets registered in
- 21 registrations outside the US
- Establishments
- 0—
510(k) clearances per year, 2007–2026
Registered in 2 markets
Where regulators' registries name Dentalpoint AG 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 | Dentalpoint AG | 4 clearances | 2014–2018 | Below |
| Australia | TGA | Manufacturer | Dentalpoint AG | 1 | 2018–2018 | 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 Dentalpoint AG as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 16 Nov 2018 | K180184 | Zeramex(R) XT Dental Implant System, NobelPearl Dental Implant System | NHA Endosseous Dental Implant Abutment |
| 30 Nov 2016 | K163043 | Zeramex P6 Dental Implant System | DZE Root-Form Endosseous Implant |
| 27 Jul 2016 | K152385 | Zeramex P6 Dental Implant System | DZE Root-Form Endosseous Implant |
| 12 Aug 2014 | K133255 | ZERAMEX T AND ZERAMEX PLUS DENTAL IMPLANT SYSTEMS | DZE Root-Form Endosseous Implant |
Some of these clearances are listed with FDA today by another company: CeramTec Schweiz GmbH (3), Nobel Biocare Services AG (1), SIC invent AG (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.