Manufacturer registered with FDA
bredent GmbH & Co. KG
Senden, Germany. Lists 13 dental device types with FDA across 1 registered establishment, and holds 3 510(k) clearances as applicant.
- Device types listed
- 13
- Brands and models
- 6
- 510(k) clearances
- 32010–2024
- Markets registered in
- 11427 registrations outside the US
- Establishments
- 1Germany
510(k) clearances per year, 2007–2026
Registered in 11 markets
Where regulators' registries name bredent 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 | bredent GmbH & Co. KG | 3 clearances | 2010–2024 | Below |
| Canada | Health Canada | Registration holder | BREDENT GMBH & CO. KG | 180 | 1999–2026 | Pure Global AI |
| South Korea | MFDS | Manufacturer | Bredent GmbH & Co. KGbredent GmbH & Co. KG · bredent GmbH & Co.KG | 55 | 1998–2019 | Pure Global AI |
| European Union | EUDAMED | Registration holder | bredent GmbH & Co. KG | 46 | — | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | bredent GmbH & Co.KG | 43 | — | Pure Global AI |
| Serbia | ALIMS | Manufacturer | bredent GmbH & Co. KG | 35 | 2024–2025 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | BREDENT GMBH & CO. KGbredent GmbH & Co. KG · Bredent GmbH & Co. KG | 33 | 2007–2020 | Pure Global AI |
| Australia | TGA | Manufacturer | Bredent GmbH & Co KG | 18 | 2017–2022 | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | bredent GmbH & Co. KG | 14 | — | Pure Global AI |
| China | NMPA | Registration holder | 倍德恩股份有限公司bredent GmbH & Co. KG | 2 | — | Pure Global AI |
| Peru | DIGEMID | Manufacturer | BREDENT GmbH & Co. KG. | 1 | 2024–2024 | 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 bredent GmbH & Co. KG currently lists, by FDA device type, with the brand and model names on the listing.
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names bredent GmbH & Co. KG as the applicant.
Also lists devices cleared under other names
bredent GmbH & Co. KG lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Bredent-Products For the Dental Technician Laborat (2).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 21 Dec 2005 | K052780 | DENTAPLAST HOT, MODEL 16-XXX | Bredent-Products For the Dental Technician Laborat | EBI Rebasing Repairing Relining Denture Resin |
| 20 Dec 2005 | K052779 | BRECOMP | Bredent-Products For the Dental Technician Laborat | EBF Resin Tooth Shade Material |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| BREDENT GMBH & CO.KGFDA reg. 1000303432 | SENDEN Bavaria, Germany | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9027334). 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.