# K252430: Freeprint® denture flex

- Pathway: 510(k) (Traditional)
- Applicant: Detax GmbH
- Decided: Oct 30, 2025 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: 5 generations back to K011560 (2001). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200461: Freeprint denture, Detax GmbH & Co. KG (2020) Summary page 5.

## Indications for use
The Freeprint® denture flex is a light-curable polymerizable resin intended to be used in conjunction with extra-oral curing light equipment. The Freeprint® denture flex is indicated for the fabrication, by additive manufacturing, of dental objects such as flexible partial removable dentures.

Source page: https://510kreport.com/device/K252430
Methodology: https://510kreport.com/methodology