Manufacturer registered with FDA
Tontarra Medizintechnik GmbH
WURMLINGEN, Germany. Lists 22 dental device types with FDA across 1 registered establishment.
- Device types listed
- 22
- Brands and models
- 14
- 510(k) clearances
- 0as applicant
- Markets registered in
- 153,333 registrations outside the US
- Establishments
- 1Germany
Registered in 15 markets
Where regulators' registries name Tontarra Medizintechnik 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 | Tontarra Medizintechnik GmbH | 22 device types | — | Below |
| Thailand | Thai FDA | Manufacturer | TONTARRA MEDIZINTECHNIK GMBH | 2,821 | — | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | TONTARRA Medizintechnik GmbH | 227 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | TONTARRA Medizintechnik GmbHTontarra Medizintechnik GmbH · TONTARRA MEDIZINTECHNIK GMBH | 96 | 2004–2026 | Pure Global AI |
| Peru | DIGEMID | Manufacturer | TONTARRA MEDIZINTECHNIK GmbHTONTARRA MEDIZINTECHNIK GMBH | 53 | 2019–2026 | Pure Global AI |
| Canada | Health Canada | Registration holder | TONTARRA MEDIZINTECHNIK GMBH | 37 | 2021–2026 | Pure Global AI |
| Australia | TGA | Manufacturer | Tontarra Medizintechnik GmbH | 30 | 2006–2026 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | TONTARRA MEDIZINTECHNIK GMBH | 18 | 2010–2020 | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | TONTARRA Medizintechnik GmbHTontarra Medizintechnik | 18 | — | Pure Global AI |
| Colombia | INVIMA | Manufacturer | TONTARRA MEDIZINTECHNIK GMBH | 8 | — | Pure Global AI |
| Egypt | EDA | Manufacturer | TONTARRA Medizintechnik GmbH, | 8 | 2026–2026 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | TONTARRA MEDIZINTECHNIK GMBH | 7 | 2005–2024 | Pure Global AI |
| Israel | AMAR | Manufacturer | Tontarra Medizintechnik GmbH | 5 | — | Pure Global AI |
| China | NMPA | Registration holder | 通特纳医疗器械有限公司Tontarra Medizintechnik GmbH | 3 | — | Pure Global AI |
| European Union | EUDAMED | Manufacturer | Tontarra Medizintechnik GmbH | 2 | — | 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 Tontarra Medizintechnik GmbH currently lists, by FDA device type, with the brand and model names on the listing.
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 |
|---|---|---|
| TONTARRA MEDIZINTECHNIK GMBHFDA reg. 9680515 | WURMLINGEN Baden-Wurttemberg, Germany | Contract manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9009570). 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.