Manufacturer registered with FDA
Karl Hammacher GmbH
SOLINGEN, Germany. Lists 13 dental device types with FDA across 1 registered establishment.
- Device types listed
- 13
- Brands and models
- 15
- 510(k) clearances
- 0as applicant
- Markets registered in
- 6180 registrations outside the US
- Establishments
- 1Germany
Registered in 6 markets
Where regulators' registries name Karl Hammacher 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 | Karl Hammacher GmbH | 13 device types | — | Below |
| South Korea | MFDS | Manufacturer | Karl Hammacher GmbHKARL HAMMACHER GMBH · Karl Hammacher GmbH. · +1 | 125 | 1999–2026 | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | Karl Hammacher GmbH. | 25 | — | Pure Global AI |
| European Union | EUDAMED | Manufacturer | Karl Hammacher GmbH | 12 | — | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Karl Hammacher GmbH | 10 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | KARL HAMMACHER GMBH | 8 | 2006–2019 | 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 Karl Hammacher 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 |
|---|---|---|---|---|
| Dental Hand InstrumentsDZN · Class 1 | Dental hand instruments | Maker | Choking Rescue DeviceFluid Fighter Suction Mat; Suction Mat; Suction Ring; Suction Ring With Tubing; Apparatus Suction; Suction CatheterKarl Hammacher GmbH | 1988 |
| Orthodontic Ligature Tucking InstrumentECP · Class 1 | Dental hand instruments | Maker | Karl Hammacher GmbH | 1978 |
| Orthodontic Band SetterECR · Class 1 | Dental hand instruments | Maker | Karl Hammacher GmbH | 1978 |
| Orthodontic Band PusherECS · Class 1 | Dental hand instruments | Maker | Karl Hammacher GmbH | 1978 |
| Rubber Dam ClampEEF · Class 1 | Rubber dam systems | Maker | Karl Hammacher GmbH | 1978 |
| Dental Surgical Tissue ScissorsEGN · Class 1 | Dental hand instruments | Maker | Karl Hammacher GmbH | 1978 |
| All Types RetractorEIG · Class 1 | Dental hand instruments | Maker | Karl Hammacher GmbH | 1978 |
| Collar and Crown ScissorsEIR · Class 1 | Dental hand instruments | Maker | Karl Hammacher GmbH | 1978 |
| Dental Plastic Filling InstrumentEIY · Class 1 | Dental hand instruments | Maker | Karl Hammacher GmbH | 1978 |
| Operative Dental ExcavatorEKC · Class 1 | Dental hand instruments | Maker | Karl Hammacher GmbH | 1978 |
| Surgical Rongeur ForcepsEMH · Class 1 | Dental hand instruments | Maker | Karl Hammacher GmbH | 1978 |
| Dental Surgical ElevatorEMJ · Class 1 | Dental hand instruments | Maker | Karl Hammacher GmbH | 1978 |
| Orthodontic PlierJEX · Class 1 | Dental hand instruments | Maker | Karl Hammacher GmbH | 1978 |
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 |
|---|---|---|
| KARL HAMMACHER GMBHFDA reg. 9610809 | SOLINGEN North Rhine-Westphalia, Germany | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 8010170). 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.