Manufacturer registered with FDA
BUSCH & CO. GmbH & Co. KG
ENGELSKIRCHEN, Germany. Lists 9 dental device types with FDA across 1 registered establishment.
- Device types listed
- 9
- Brands and models
- 16
- 510(k) clearances
- 0as applicant
- Markets registered in
- 653 registrations outside the US
- Establishments
- 1Germany
Registered in 6 markets
Where regulators' registries name BUSCH & CO. GmbH & Co. KG 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 | BUSCH & CO. GmbH & Co. KG | 9 device types | — | Below |
| Saudi Arabia | SFDA | Manufacturer | BUSCH & CO. GmbH & Co. KG | 41 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | BUSCH & CO. GmbH & Co. KGBUSCH & CO. GmbH & Co. Kg · BUSCH & Co. GmbH & Co. KG | 6 | 2014–2026 | Pure Global AI |
| Australia | TGA | Manufacturer | BUSCH & CO GmbH & Co KG | 4 | 2005–2021 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | BUSCH & CO. GmbH & Co. KG | 1 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | BUSCH & CO. GmbH & Co. KG | 1 | 2025–2025 | 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 BUSCH & CO. GmbH & Co. KG 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 Diamond InstrumentDZP · Class 1 | Dental burs & diamonds | Maker | DIAMONDS | 1979 |
| Abrasive DiskEHJ · Class 1 | Polishing & prophylaxis | Maker | ABRASIVE DEVICE AND ACCESSORIESUNMOUNTED WHEELS | 1979 |
| Abrasive PointEHL · Class 1 | Polishing & prophylaxis | Maker | ABRASIVE DEVICE AND ACESSORIESMOUNTED POINTS | 1979 |
| Dental BurEJL · Class 1 | Dental burs & diamonds | Maker | EXCAVATING BURRSFISSURE BURRSINLAY BURRSPLUG FINISHING AND BURNISHING BURRSVARIOUS TYPES OF EXCAVATING BURRS | 1979 |
| Operative Cutting InstrumentEKD · Class 1 | Dental hand instruments | Maker | SURGICAL BURSVARIOUS TYPES OF BONE CUTTERS | 1979 |
| Endodontic Pulp Canal ReamerEKP · Class 1 | Endodontic files | Maker | REAMER | 1979 |
| Root Canal Endodontic PreparerEKQ · Class 1 | Endodontic files | Maker | ROOT CANAL DRILLS | 1979 |
| Endodontic Root Canal PluggerEKR · Class 1 | Dental hand instruments | Maker | ROOT FILLERS | 1979 |
| Endodontic Pulp Canal FileEKS · Class 1 | Endodontic files | Maker | ROOT CANAL FILES | 1979 |
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 |
|---|---|---|
| BUSCH & CO. GmbH & Co. KGFDA reg. 9611611 | ENGELSKIRCHEN North Rhine-Westphalia, Germany | Contract manufacturer, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 8010426). 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.