Manufacturer registered with FDA
Gunmed Technik AG
Welschenrohr, Switzerland. Lists 2 dental device types with FDA across 1 registered establishment.
- Device types listed
- 2
- Brands and models
- 2
- 510(k) clearances
- 0as applicant
- Markets registered in
- 43 registrations outside the US
- Establishments
- 1Switzerland
Registered in 4 markets
Where regulators' registries name Gunmed Technik AG 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 | Gunmed Technik AG | 2 device types | — | Below |
| Colombia | INVIMA | Manufacturer | GUNMED TECHNIK AG | 1 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | Gunmed Technik AG | 1 | 2013–2013 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | GUNMED TECHNIK AG | 1 | 2006–2006 | 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 Gunmed Technik AG currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Orthodontic Extraoral HeadgearDZB · Class 2 | Retainers, expanders & headgear | Maker | HOOD GEAR (TM) BREAKAWAY HEADGEAR WITH NECK STRAP | 2022 |
| Dental Instrument Depth GaugeEIL · Class 1 | Dental hand instruments | Maker | Model No. 801-0000 | 2019 |
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 |
|---|---|---|
| GUNMED TECHNIK AGFDA reg. 3001778198 | WELSCHENROHR Solothurn, Switzerland | Contract manufacturer, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9050706). 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.