# K220979: SprintRay Denture Base

- Pathway: 510(k) (Traditional)
- Applicant: Sprintray, Inc.
- Decided: Sep 14, 2022 after 163 days
- Product code: EBI (Resin, Denture, Relining, Repairing, Rebasing)
- Device class: 2
- Regulation: 21 CFR 872.3760
- 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 K011560 (2001). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143033: Dentca Denture Base, Dentca, Inc. (2015) Summary page 4.

## Most influential descendants
- K260569: DB 4000 High Impact Denture Base (2026), 0 descendants of its own

## Indications for use
SprintRay Denture Base resin is a light-curable polymerizable resin intended to be used for the fabrication and repair, of full and partial removable dentures and baseplates. The material is an alternative to traditional denture base material. Fabrication of dental prosthetics with SprintRay Denture Base resin requires computer-aided design and manufacturing system that includes the following components not part of the device: oral casting impression, digital denture base file created in an optical impression system, 3D printer, and curing light equipment.

Source page: https://510kreport.com/device/K220979
Methodology: https://510kreport.com/methodology