# K201563: PuRE PMMA Disc

- Pathway: 510(k) (Special)
- Applicant: Quest Dental USA Corp.
- Decided: Apr 9, 2021 after 303 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 K093708 (2010). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172281: PuRE PMMA Disc, Quest Dental USA Corp. (2017) Summary page 6.

## 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/K201563
Methodology: https://510kreport.com/methodology