Not currently registered with FDA under this name
White Peaks Dental Systems GmbH & Co. KG
Essen, Germany. Named as applicant on 2 dental 510(k) clearances between 2009 and 2013. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 22009–2013
- Markets registered in
- 21 registrations outside the US
- Establishments
- 0—
510(k) clearances per year, 2000–2026
Registered in 2 markets
Where regulators' registries name White Peaks Dental Systems 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 | Applicant | White Peaks Dental Systems GmbH & Co. KG | 2 clearances | 2009–2013 | Below |
| Taiwan | TFDA | Manufacturer | WHITE PEAKS DENTAL SYSTEMS GMBH & CO. KG | 1 | 2013–2013 | 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
510(k) clearances
Clearances on which FDA names White Peaks Dental Systems GmbH & Co. KG as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 21 Feb 2013 | K123680 | COPRANCOLOR | EIH Porcelain Powder |
| 18 Sep 2009 | K092496 | COPRAN ZR/ORIGIN YZ | EIH Porcelain Powder |
Some of these clearances are listed with FDA today by another company: Whitepeaks Dental Solutions GmbH (2).
Sources
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 of the most recent filing, which can be a US agent.