Manufacturer registered with FDA
Rudolf Storz GmbH
EMMINGEN, Germany. Lists 6 dental device types with FDA across 1 registered establishment.
- Device types listed
- 6
- Brands and models
- 0
- 510(k) clearances
- 0as applicant
- Markets registered in
- 672 registrations outside the US
- Establishments
- 1Germany
Registered in 6 markets
Where regulators' registries name Rudolf Storz 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 | Rudolf Storz GmbH | 6 device types | — | Below |
| South Korea | MFDS | Manufacturer | Rudolf Storz GmbHRUDOLF STORZ GMBH · Rudolf Storz GMBH · +2 | 60 | 1999–2026 | Pure Global AI |
| Australia | TGA | Manufacturer | Rudolf Storz GmbH | 6 | 2004–2017 | Pure Global AI |
| Colombia | INVIMA | Manufacturer | RUDOLF STORZ GMBH | 4 | — | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | RUDOLF STORZ GMBH | 1 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | RUDOLF STORZ GMBH | 1 | 2017–2017 | 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 Rudolf Storz 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 |
|---|---|---|---|---|
| Retentive and Splinting Pin and Accessory InstrumentsEBL · Class 1 | — | Maker | — | 1986 |
| Dental Instrument Depth GaugeEIL · Class 1 | Dental hand instruments | Maker | — | 2021 |
| Operative CuretteEKE · Class 1 | Dental hand instruments | Maker | — | 1998 |
| Surgical Rongeur ForcepsEMH · Class 1 | Dental hand instruments | Maker | — | 2013 |
| Surgical Bone FileEMI · Class 1 | Dental hand instruments | Maker | — | 2013 |
| Surgical Bone ChiselEML · Class 1 | Dental hand instruments | Maker | — | 1986 |
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 |
|---|---|---|
| RUDOLF STORZ GMBHFDA reg. 9611274 | EMMINGEN Baden-Wurttemberg, Germany | Contract manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 8010286). 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.