Manufacturer registered with FDA
OpInstruments GmbH
Rosbach vor der Hoehe, 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
- 262 registrations outside the US
- Establishments
- 1Germany
Registered in 2 markets
Where regulators' registries name OpInstruments 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 | OpInstruments GmbH | 1 device types | — | Below |
| South Korea | MFDS | Manufacturer | OpInstruments GmbHOpInstruments | 62 | 2019–2026 | 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 OpInstruments 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 |
|---|---|---|---|---|
| Surgical Headlight LightEBA · Class 1 | Dental operating lights | Maker | Medical Headlight | 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 |
|---|---|---|
| OPINSTRUMENTS GMBHFDA reg. 3014268446 | Rosbach vor der Hoehe Hesse, Germany | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10056684). 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.