# K172281: PuRE PMMA Disc

- Pathway: 510(k) (Traditional)
- Applicant: Quest Dental USA Corp.
- Decided: Oct 19, 2017 after 83 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: 1 generation back to K093708 (2010). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093708: Telio Cad, Ivoclar Vivadent, Inc. (2010) Summary page 4.

## Most influential descendants
- K261456: Ruthinium Disc (2026), 0 descendants of its own
- K201563: PuRE PMMA Disc (2021), 0 descendants of its own

## Indications for use
PuRE PMMA Discs are polymethyl methacrylate blanks used to mill dental long-term temporary crowns and bridges in various CAD/CAM systems until permanent restorations can be delivered. Restorations are designed and manufactured by dental professionals and technicians using open CAD/CAM technology.

Source page: https://510kreport.com/device/K172281
Methodology: https://510kreport.com/methodology