# K122025: Brightglass Brightglass M

- Pathway: 510(k) (Traditional)
- Applicant: Ktk Medical Supplies GmbH
- Decided: Oct 9, 2012 after 90 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: 2 generations back to K070991 (2007). 2 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 9 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.

## Most influential descendants
- K131664: Copra Temp Pmma-Disk (2013), 4 descendants of its own
- 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
BRIGHTGLASS Discs are milling blanks consisting of Polymethylmethacrylate (PMMA) and designed for the fabrication of long-term temporary crown and bridgework. They are machined with the CAD/CAM technique. BRIGHTGLASS Discs are recommended for manufactuing substructures of single tooth crowns and bridgework with up to two pontics.

Source page: https://510kreport.com/device/K122025
Methodology: https://510kreport.com/methodology