# K261626: UltraPrint Flexible Denture UV

- Pathway: 510(k) (Traditional)
- Applicant: Guangzhou Heygears IMC., Inc.
- Decided: Aug 13, 2026 after 90 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
UltraPrint Flexible Denture UV is indicated for the fabrication of partial removable dentures and intended for continuous use not to exceed 30 days and until the permanent denture is fabricated and placed. It is intended exclusively for professional dental work.

Source page: https://510kreport.com/device/K261626
Methodology: https://510kreport.com/methodology