# K230445: OnX Tough

- Pathway: 510(k) (Traditional)
- Applicant: Sprintray, Inc.
- Decided: Jul 14, 2023 after 143 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: 6 generations back to K901789 (1990). 17 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 20 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 4.
- K151142: Ivobase Cad for Zenotec, Ivobase Cad Bond, Ivobase Cad Modelling Liquid, Wieland Dental + Technik GmbH & Co. KG (2015) Summary page 4.

## Most influential descendants
- K240688: RODIN Titan 3D Resin (2024), 1 descendant of its own
- K262681: NanoCeram Resin (2026), 0 descendants of its own

## Indications for use
SprintRay OnX Tough is a tooth shade ceramic-hybrid resin used for the fabrication of hybrid denture prosthetics, implant-supported denture prosthetics, monolithic full and partial removable dentures, and preformed denture teeth to be used in a denture.

Source page: https://510kreport.com/device/K230445
Methodology: https://510kreport.com/methodology