Manufacturer registered with FDA
CeramTec Schweiz GmbH
Spreitenbach, Switzerland. Lists 5 dental device types with FDA across 1 registered establishment.
- Device types listed
- 5
- Brands and models
- 5
- 510(k) clearances
- 0as applicant
- Markets registered in
- 479 registrations outside the US
- Establishments
- 1Switzerland
Registered in 4 markets
Where regulators' registries name CeramTec Schweiz GmbH as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | CeramTec Schweiz GmbH | 5 device types | — | Below |
| United Kingdom | MHRA | Manufacturer | CeramTec Schweiz GmbH | 44 | — | Pure Global AI |
| Australia | TGA | Manufacturer | CeramTec Schweiz GmbH | 20 | 2018–2025 | Pure Global AI |
| European Union | EUDAMED | Registration holder | CeramTec Schweiz GmbH | 15 | — | 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
Devices listed with FDA
What CeramTec Schweiz GmbH currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Root-Form Endosseous ImplantDZE · Class 2 | Dental implants | Maker | Zeramex Dental Implant System | 2016 |
| Endosseous Dental Implant AbutmentNHA · Class 2 | Implant abutments | Maker | Zeramex Dental Implant System | 2016 |
| Dental BurEJL · Class 1 | Dental burs & diamonds | Maker | Zeramex Dental Implant System | 2010 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | Zeramex Dental Implant System | 2016 |
| General Purpose Dental TrayOFX · Class 1 | — | Maker | Zeramex Dental Implant System | 2018 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Also lists devices cleared under other names
CeramTec Schweiz GmbH lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Dentalpoint AG (3).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 16 Nov 2018 | K180184 | Zeramex(R) XT Dental Implant System, NobelPearl Dental Implant System | Dentalpoint AG | NHA Endosseous Dental Implant Abutment |
| 30 Nov 2016 | K163043 | Zeramex P6 Dental Implant System | Dentalpoint AG | DZE Root-Form Endosseous Implant |
| 27 Jul 2016 | K152385 | Zeramex P6 Dental Implant System | Dentalpoint AG | DZE Root-Form Endosseous Implant |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| CeramTec Schweiz GmbHFDA reg. 3008388248 | Spreitenbach Aargau, Switzerland | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10032409). 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.