# K261474: DENTCA Tru Flexible

- Pathway: 510(k) (Traditional)
- Applicant: Dentca, Inc.
- Decided: Jul 1, 2026 after 58 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 K053060 (2006). 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)
- K250617: Apex Flex, Sprintray, Inc. (2025) Summary page 5.

## Indications for use
DENTCA Tru Flexible is a light-curable resin indicated for the fabrication of removable flexible full and partial denture bases in dental laboratories or dental office. The material is also indicated for fabrication of try-in dentures for clinical evaluation and as an aid for bonding denture teeth to denture bases.

Source page: https://510kreport.com/device/K261474
Methodology: https://510kreport.com/methodology