Data / Medical devices / Germany / Whitepeaks Dental Solutions GMBH
Whitepeaks Dental Solutions GMBH: FDA-registered device maker in Hamminkeln North Rhine-Westphalia, Germany, 3 510(k) clearances
Whitepeaks Dental Solutions GMBH is registered with the FDA (registration 3009409473) in Hamminkeln North Rhine-Westphalia, Germany. It lists 3 device types. The FDA files 3 510(k) clearances under its listings, the newest dated December 18, 2013. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3009409473
- Address
- Weikenrott 17, Hamminkeln North Rhine-Westphalia, Germany, 46499
- Owner or operator
- Whitepeaks Dental Solutions GmbH (10047737)
- Roles
- Manufacturer
- First device listed
- October 26, 2014
- Registered through
- 2026
- Brand names listed
- Copra Ti-2, Copra Ti-4, Copra Ti-5, CopraBond K, CopraSintek K, CopraTemp, Copran Color, Copran Zr
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Alloy, Metal, Base | EJH | 2 | Manufacturer | accessdata.fda.gov |
| Crown And Bridge, Temporary, Resin | EBG | 2 | Manufacturer | accessdata.fda.gov |
| Powder, Porcelain | EIH | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 18, 2013 | K131664 | COPRA TEMP PMMA-DISK | EBG | Substantially Equivalent | White Peaks Dental Systems GmbH & Co. KG | accessdata.fda.gov |
| February 21, 2013 | K123680 | COPRANCOLOR | EIH | Substantially Equivalent | White Peaks Dental Systems GmbH & Co. KG | accessdata.fda.gov |
| September 18, 2009 | K092496 | COPRAN ZR/ORIGIN YZ | EIH | Substantially Equivalent | White Peaks Dental Systems GmbH & Co. KG | accessdata.fda.gov |
Compare with other makers
- All makers of Powder, Porcelain
- All makers of Alloy, Metal, Base
- All makers of Crown And Bridge, Temporary, Resin
Updated December 18, 2013. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.