# Whitepeaks Dental Solutions GmbH

- Location (FDA's records): Essen, DE
- FDA decisions: 3 (2024–2024): 3 510(k) clearances
- Product codes: EIH (3)
- 510(k) review time since 2016: median 277 days, against 89 for FDA's reviews in the same codes and years (0 of 3 faster)
- Predicates its devices cite: 3 (0 its own); citations of its devices by later devices: 0 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Ivoclar Vivadent, Inc.: 1 (https://510kreport.com/company/ivoclar-vivadent)
- Prismatik Dentalcraft, Inc.: 1 (https://510kreport.com/company/prismatik-dentalcraft)
- 3M Deutschland GmbH: 1 (https://510kreport.com/company/3m-deutschland)

## Recent decisions
- K233064: Copra Supreme (Sep 18, 2024)
- K232952: Copran Zri (Jun 24, 2024)
- K233158: Copra Smile, Copra Supreme Hyperion (Jun 20, 2024)

Source page: https://510kreport.com/company/whitepeaks-dental-solutions