Manufacturer registered with FDA
HGR Instrumente GmbH
TUTTLINGEN, Germany. Lists 7 dental device types with FDA across 1 registered establishment.
- Device types listed
- 7
- Brands and models
- 0
- 510(k) clearances
- 0as applicant
- Markets registered in
- 5131 registrations outside the US
- Establishments
- 1Germany
Registered in 5 markets
Where regulators' registries name HGR Instrumente 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 | HGR Instrumente GmbH | 7 device types | — | Below |
| Thailand | Thai FDA | Manufacturer | HGR INSTRUMENTE GMBH | 75 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | HGR Instrumente GmbHHGR Instrumente GMBH · HGR INSTRUMENTE GMBH | 51 | 1999–2026 | Pure Global AI |
| Australia | TGA | Manufacturer | HGR Instrumente GmbH | 3 | 2004–2004 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | HGR INSTRUMENTE GMBH | 2 | 2006–2017 | 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 HGR Instrumente 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 |
|---|---|---|---|---|
| All Types RetractorEIG · Class 1 | Dental hand instruments | Maker | — | 1999 |
| Dental Instrument HandleEJB · Class 1 | Dental hand instruments | Maker | — | 2020 |
| Operative BurnisherEKJ · Class 1 | Dental hand instruments | Maker | — | 2020 |
| Dental Surgical ElevatorEMJ · Class 1 | Dental hand instruments | Maker | — | 2023 |
| Dental Surgical CuretteEMK · Class 1 | Dental hand instruments | Maker | — | 2022 |
| Surgical Bone ChiselEML · Class 1 | Dental hand instruments | Maker | — | 2012 |
| Surgical Osteotome ChiselEMM · Class 1 | Dental hand instruments | Maker | — | 2013 |
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 |
|---|---|---|
| HGR INSTRUMENTE GMBHFDA reg. 8044098 | TUTTLINGEN Baden-Wurttemberg, Germany | Contract manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9067456). 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.