# K250617: Apex Flex

- Pathway: 510(k) (Traditional)
- Applicant: Sprintray, Inc.
- Decided: Apr 29, 2025 after 60 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 K053060 (2006). 2 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072402: Flex-Star V, Cmp Industries, LLC (2007) Summary page 5.
- K053060: TCS Unbreakable, Thermoplastic Comfort Systems, Inc. (2006) Summary page 5.

## Most influential descendants
- K261626: UltraPrint Flexible Denture UV (2026), 0 descendants of its own
- K261474: DENTCA Tru Flexible (2026), 0 descendants of its own
- K253365: LuxCreo Flexible Partial Denture Resin (2025), 0 descendants of its own

## Indications for use
SprintRay Apex Flex is an alternative to traditional thermoplastic material used for the fabrication and repair of partial dentures. It is intended exclusively for professional dental work.

Source page: https://510kreport.com/device/K250617
Methodology: https://510kreport.com/methodology