Manufacturer registered with FDA
Andreas Hettich GmbH
Tuttlingen, Germany. Lists 1 dental device type with FDA across 1 registered establishment.
- Device types listed
- 1
- Brands and models
- 1
- 510(k) clearances
- 0as applicant
- Markets registered in
- 837 registrations outside the US
- Establishments
- 1Germany
Registered in 8 markets
Where regulators' registries name Andreas Hettich 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 | Andreas Hettich GmbH | 1 device types | — | Below |
| European Union | EUDAMED | Manufacturer | Andreas Hettich GmbH | 24 | — | Pure Global AI |
| Canada | Health Canada | Registration holder | ANDREAS HETTICH GMBH | 4 | 2011–2017 | Pure Global AI |
| Israel | AMAR | Manufacturer | Andreas Hettich GmbH | 3 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | Andreas Hettich GmbHAndreas Hettich | 3 | 2025–2026 | Pure Global AI |
| Australia | TGA | Manufacturer | Andreas Hettich GmbH | 1 | 2025–2025 | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | Andreas Hettich GmbH | 1 | — | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Andreas Hettich GmbH | 1 | — | 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 Andreas Hettich 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 |
|---|---|---|---|---|
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | Intra-Spin System | 2021 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| ANDREAS HETTICH GMBHFDA reg. 3005990076 | TUTTLINGEN Baden-Wurttemberg, Germany | Contract manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9020624). 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.