Manufacturer registered with FDA
Dr. Wittmann GmbH & Co. KG
Zwingenberg, 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
- 711 registrations outside the US
- Establishments
- 1Germany
Registered in 7 markets
Where regulators' registries name Dr. Wittmann GmbH & Co. KG 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 | Dr. Wittmann GmbH & Co. KG | 1 device types | — | Below |
| South Korea | MFDS | Manufacturer | Dr. Wittmann GmbH & CO.KGDr.Wittmann GmbH & Co.KG · Dr. Wittmann Gmbh & Co.KG | 5 | 2008–2026 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | Dr. Wittmann GmbH & Co. KG | 2 | — | Pure Global AI |
| Australia | TGA | Manufacturer | Dr Wittmann GmbH & Co KG | 1 | 2017–2017 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | DR. WITTMANN GMBH & CO KG | 1 | 2020–2020 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | Dr. Wittmann GmbH & Co. KG | 1 | 2020–2020 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Dr. Wittmann GmbH & Co. KG | 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 Dr. Wittmann GmbH & Co. KG currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Oral Cavity Abrasive Polishing AgentEJR · Class 1 | Polishing & prophylaxis | Maker | Airflow Classic, Airflow Perio, Airflow Plus | 2024 |
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 |
|---|---|---|
| DR. WITTMANN GMBH & CO. KGFDA reg. 3006611932 | Zwingenberg Hesse, Germany | Contract manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10090864). 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.