Class Class II
Copra Supreme (K233064)
Description
Copra Supreme by Whitepeaks Dental Solutions GmbH, an FDA 510(k) cleared dental device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK233064
Clearance Date2024-09-18
Clearance TypeTraditional
Product CodeEIH
Regulation Number872.6660
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K233064
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. Copra Supreme (K233064) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K213425 | BruxZir Esthetic | Prismatik Dentalcraft, Inc. | 2021 |
| K092496 | COPRAN ZR/ORIGIN YZ | White Peaks Dental Systems GmbH & C... | 2009 |
Trace the full predicate network for K233064
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.