# K243103: Denture Base

- Pathway: 510(k) (Traditional)
- Applicant: Riton 3D Technology Co., Ltd.
- Decided: Dec 23, 2024 after 84 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: 2 generations back to K162044 (2017). 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)
- K221678: SprintRay High Impact Denture Base, Sprintray, Inc. (2022) Summary page 5.

## Indications for use
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/K243103
Methodology: https://510kreport.com/methodology