Not currently registered with FDA under this name
Vita Zahnfabrik H.Rauter GmbH Co.
Bad Sackingen, Germany. Named as applicant on 2 dental 510(k) clearances between 2016 and 2018. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 22016–2018
- Markets registered in
- 22 registrations outside the US
- Establishments
- 0—
510(k) clearances per year, 2007–2026
Registered in 2 markets
Where regulators' registries name Vita Zahnfabrik H.Rauter GmbH Co. 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 | Vita Zahnfabrik H.Rauter GmbH Co. | 2 clearances | 2016–2018 | Below |
| South Korea | MFDS | Manufacturer | VITA Zahnfabrik H.Rauter GmbH Co., KG | 2 | 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 Vita Zahnfabrik H.Rauter GmbH Co. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 1 Aug 2018 | K180703 | VITA YZ ST and VITA YZ XT | EIH Porcelain Powder |
| 30 Jun 2016 | K153645 | VITA ENAMIC Implant Solutions (IS) | NHA Endosseous Dental Implant Abutment |
Some of these clearances are listed with FDA today by another company: Vita Zahnfabrik H. Rauter GmbH & Co. Kg. (2), Dentsply Sirona, Inc. (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.