Manufacturer registered with FDA
Dr. Jean Bausch GmbH & Co. KG
Cologne, Germany. Lists 3 dental device types with FDA across 1 registered establishment.
- Device types listed
- 3
- Brands and models
- 5
- 510(k) clearances
- 0as applicant
- Markets registered in
- 966 registrations outside the US
- Establishments
- 1Germany
Registered in 9 markets
Where regulators' registries name Dr. Jean Bausch 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 | Dr. Jean Bausch GmbH & Co. KG | 3 device types | — | Below |
| Brazil | ANVISA | Manufacturer | DR. JEAN BAUSCH GMBH & CO. KGDR. JEAN BAUSCH GMBH & CO · DR. JEAN. BAUSCH GMBH & CO. KG | 20 | 2009–2026 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | Dr. Jean Bausch GmbH & Co. KG | 18 | — | Pure Global AI |
| Serbia | ALIMS | Manufacturer | Dr. Jean Bausch GmbH & Co. KG | 7 | 2021–2021 | Pure Global AI |
| South Korea | MFDS | Manufacturer | Dr. Jean Bausch GmbH & Co. KGDr.Jean Bausch GmbH & Co.KG | 7 | 2011–2025 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | DR. JEAN BAUSCH GMBH & CO.KGDr. Jean Bausch GmbH & Co.KG | 6 | 2006–2021 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Dr. Jean Bausch GmbH & Co. KG | 6 | — | Pure Global AI |
| China | NMPA | Registration holder | 宝诗公司Dr. Jean Bausch GmbH&Co. KG | 1 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | Dr.Jean Bausch GmbH & Co. KG | 1 | — | 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 Dr. Jean Bausch 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 |
|---|---|---|---|---|
| Articulation PaperEFH · Class 1 | — | Maker | ARTICULATING PAPERSOccluSense | 1989 |
| Articulation Paper ForcepsEFK · Class 1 | Dental hand instruments | Maker | Bausch Arti-Fol ForcepsBausch Articulating Paper Forceps | 2013 |
| Intraoral Dental WaxEGD · Class 1 | — | Maker | Arti-Pink Bite Wax | 2024 |
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 |
|---|---|---|
| Dr. Jean Bausch GmbH & Co. KGFDA reg. 8010224 | COLOGNE North Rhine-Westphalia, Germany | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 8010224). 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.