# K233158: Copra Smile, Copra Supreme Hyperion

- Pathway: 510(k) (Traditional)
- Applicant: Whitepeaks Dental Solutions GmbH
- Decided: Jun 20, 2024 after 267 days
- Product code: EIH (Powder, Porcelain)
- Device class: 2
- Regulation: 21 CFR 872.6660
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K011394 (2001). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161922: XP202, 3M Deutschland GmbH (2016) Summary page 6.

## Indications for use
Copra Smile consists of machinable zirconia discs and blocks for preparation of single crowns, bridges with maximum of one pontic between two crowns and inlays, onlays and veneers. Copra Supreme Hyperion consists of machinable zirconia discs and blocks for the preparation of full ceramic crowns, onlays and 3- and 4-unit bridges and inlay bridges (anterior and molar).

Source page: https://510kreport.com/device/K233158
Methodology: https://510kreport.com/methodology