Manufacturer registered with FDA
Whitepeaks Dental Solutions GmbH
Hamminkeln, Germany. Lists 3 dental device types with FDA across 1 registered establishment, and holds 3 510(k) clearances as applicant.
- Device types listed
- 3
- Brands and models
- 8
- 510(k) clearances
- 32024–2024
- Markets registered in
- 614 registrations outside the US
- Establishments
- 1Germany
510(k) clearances per year, 2007–2026
Registered in 6 markets
Where regulators' registries name Whitepeaks Dental Solutions 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 | Whitepeaks Dental Solutions GmbH | 3 clearances | 2024–2024 | Below |
| United Kingdom | MHRA | Manufacturer | Whitepeaks Dental Solutions GmbH | 5 | — | Pure Global AI |
| Australia | TGA | Manufacturer | Whitepeaks Dental Solutions GmbH | 3 | 2023–2024 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | Whitepeaks Dental Solutions GmbH | 3 | 2021–2026 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | Whitepeaks Dental Solutions GmbH | 2 | — | Pure Global AI |
| Serbia | ALIMS | Manufacturer | Whitepeaks Dental Solutions GmbH | 1 | 2023–2023 | 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 Whitepeaks Dental Solutions 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 |
|---|---|---|---|---|
| Porcelain PowderEIH · Class 2 | Dental ceramics & zirconia | Maker | Copran ColorCopran Zr | 2014 |
| Resin Temporary Crown and BridgeEBG · Class 2 | Temporary crown & bridge materials | Maker | CopraTemp | 2016 |
| Base Metal AlloyEJH · Class 2 | Dental alloys | Maker | Copra Ti-2Copra Ti-4Copra Ti-5CopraBond KCopraSintek K | 2014 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Also lists devices cleared under other names
Whitepeaks Dental Solutions GmbH 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: White Peaks Dental Systems GmbH & Co. KG (2), White Peaks Dental Systems GmbH & Co. KG (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 18 Dec 2013 | K131664 | COPRA TEMP PMMA-DISK | White Peaks Dental Systems GmbH & Co. KG | EBG Resin Temporary Crown and Bridge |
| 21 Feb 2013 | K123680 | COPRANCOLOR | White Peaks Dental Systems GmbH & Co. KG | EIH Porcelain Powder |
| 18 Sep 2009 | K092496 | COPRAN ZR/ORIGIN YZ | White Peaks Dental Systems GmbH & Co. KG | EIH Porcelain Powder |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| WHITEPEAKS DENTAL SOLUTIONS GMBHFDA reg. 3009409473 | Hamminkeln North Rhine-Westphalia, Germany | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10047737). 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.