# K221678: SprintRay High Impact Denture Base

- Pathway: 510(k) (Traditional)
- Applicant: Sprintray, Inc.
- Decided: Nov 10, 2022 after 154 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: 1 generation back to K162044 (2017). 1 ancestor in all.
5 later devices descend from it; 3 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162044: Dentca Denture Base II, Dentca, Inc. (2017) Summary page 4.

## Most influential descendants
- K230445: OnX Tough (2023), 2 descendants of its own
- K240688: RODIN Titan 3D Resin (2024), 1 descendant of its own
- K262681: NanoCeram Resin (2026), 0 descendants of its own
- K260376: Denture Base (2026), 0 descendants of its own
- K243103: Denture Base (2024), 0 descendants of its own

## Indications for use
The SprintRay High Impact 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.

Source page: https://510kreport.com/device/K221678
Methodology: https://510kreport.com/methodology