# K242559: Digital Temp

- Pathway: 510(k) (Traditional)
- Applicant: Sprintray, Inc.
- Decided: Nov 26, 2024 after 90 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: 3 generations back to K070991 (2007). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K211101: E-Temp, Envisiontec GmbH (2021) Summary page 5.

## Indications for use
SprintRay Digital Temp is a light-curable resin indicated for the fabrication of individual and fixed temporary full single crowns, temporary partial crowns, and temporary bridges. The material is an alternative to traditional restorative dental material.

Source page: https://510kreport.com/device/K242559
Methodology: https://510kreport.com/methodology