Manufacturer registered with FDA
Julius Wirth
Northbrook, IL, United States. Lists 8 dental device types with FDA across 1 registered establishment.
- Device types listed
- 8
- Brands and models
- 5
- 510(k) clearances
- 0as applicant
- Markets registered in
- 21 registrations outside the US
- Establishments
- 1Germany
Registered in 2 markets
Where regulators' registries name Julius Wirth 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 | Julius Wirth | 8 device types | — | Below |
| Taiwan | TFDA | Manufacturer | JULIUS WIRTH LLC | 1 | 2024–2024 | 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 Julius Wirth currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Dental Dressing ForcepsEFL · Class 1 | Dental hand instruments | Maker | Hu-Friedy | 2023 |
| Dental Surgical Tissue ScissorsEGN · Class 1 | Dental hand instruments | Maker | — | 2018 |
| All Types RetractorEIG · Class 1 | Dental hand instruments | Maker | — | 2019 |
| Dental Instrument Depth GaugeEIL · Class 1 | Dental hand instruments | Maker | Hu-Friedy | 2023 |
| Rubber Dam Clamp ForcepsEJG · Class 1 | Rubber dam systems | Maker | Hu-Friedy | 2023 |
| Surgical HemostatEMD · Class 1 | Dental hand instruments | Maker | Hu-Friedy | 2023 |
| Surgical Tooth Extractor ForcepsEMG · Class 1 | Dental hand instruments | Maker | Hu-Friedy | 2023 |
| Dental Surgical ElevatorEMJ · Class 1 | Dental hand instruments | Maker | — | 2018 |
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 |
|---|---|---|
| JULIUS WIRTH LLCFDA reg. 4488 | Emmingen-Liptingen Baden-Wurttemberg, Germany | Contract manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10057651). 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.