# K131664: Copra Temp Pmma-Disk

- Pathway: 510(k) (Traditional)
- Applicant: White Peaks Dental Systems GmbH & Co. KG
- Decided: Dec 18, 2013 after 194 days
- Product code: EBG (Crown And Bridge, Temporary, Resin)
- Device class: 2
- Regulation: 21 CFR 872.3770
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K070991 (2007). 3 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080182: Zeno Pmma Disc, Wieland Dental + Technik GmbH & Co. KG (2008) Summary page 1.
- K122025: Brightglass Brightglass M, Ktk Medical Supplies GmbH (2012) Summary page 1.

## Most influential descendants
- K141421: Pmma Block (2015), 2 descendants of its own
- K190217: Aidite PMMA (2020), 1 descendant of its own
- K223477: PMMA Blocks for Dental Use (2023), 0 descendants of its own
- K152443: Vericore Gradient Temporary Disc (2016), 0 descendants of its own

## Indications for use
White Peaks Copra Temp is a device made from PMMA (polymethylmethacrylate) for the fabrication of temporary crowns and bridges and is intended for use in the oral cavity for up to six (6) months while awaiting a permanent restoration. Restorations are designed and manufactured by a dental Professional (Technician) using CAD technology.

Source page: https://510kreport.com/device/K131664
Methodology: https://510kreport.com/methodology
