Manufacturer registered with FDA
Dufner Instrumente GmbH
TUTTLINGEN, Germany. Lists 8 dental device types with FDA across 1 registered establishment.
- Device types listed
- 8
- Brands and models
- 8
- 510(k) clearances
- 0as applicant
- Markets registered in
- 657 registrations outside the US
- Establishments
- 1Germany
Registered in 6 markets
Where regulators' registries name Dufner 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 | Dufner Instrumente GmbH | 8 device types | — | Below |
| European Union | EUDAMED | Manufacturer | Dufner Instrumente GmbH | 24 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | DUFNER Instrumente GmbHDufner Instrumente GmbH · Dufner Instrumente · +1 | 21 | 2008–2026 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | DUFNER INSTRUMENTE GMBH | 7 | 2005–2020 | Pure Global AI |
| Australia | TGA | Manufacturer | Dufner Instrumente GmbH | 3 | 2026–2026 | Pure Global AI |
| Israel | AMAR | Manufacturer | Dufner Instrumente GmbH | 2 | — | 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 Dufner 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 |
|---|---|---|---|---|
| Mouth MirrorEAX · Class 1 | Dental hand instruments | Maker | MIRROR, MOUTH | 1994 |
| Retentive and Splinting Pin and Accessory InstrumentsEBL · Class 1 | — | Maker | PIN, RETENTIVE AND SPLINTING, AND ACCESSORY INSTRUMENTS | 1994 |
| Suction Operatory UnitEBR · Class 1 | Suction & evacuation units | Maker | SUCTION UNIT | 1994 |
| All Types RetractorEIG · Class 1 | Dental hand instruments | Maker | RETRACTOR, ALL TYPES | 1994 |
| Operative CuretteEKE · Class 1 | Dental hand instruments | Maker | CURETTE, OPERATIVE | 1994 |
| Surgical Rongeur ForcepsEMH · Class 1 | Dental hand instruments | Maker | FORCEPS, RONGEUR, SURGICAL | 1994 |
| Surgical Bone FileEMI · Class 1 | Dental hand instruments | Maker | FILE BONE, SURGICAL | 1994 |
| Surgical Bone ChiselEML · Class 1 | Dental hand instruments | Maker | BONE CHISELS | 1994 |
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 |
|---|---|---|
| DUFNER INSTRUMENTE GMBHFDA reg. 9612278 | TUTTLINGEN Baden-Wurttemberg, Germany | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 8010266). 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.