# K113608: Deflex

- Pathway: 510(k) (Traditional)
- Applicant: Nuxen S.R.L.
- Decided: Apr 10, 2012 after 126 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). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053060: TCS Unbreakable, Thermoplastic Comfort Systems, Inc. (2006) Summary page 1.

## Most influential descendants
- K190790: Flex Fit (2020), 0 descendants of its own

## Indications for use
This product is indicated for the manufacturing of bases of partial or full removable dentures, occiusal splints and night guards through heating and pneumatic injection of the material, following the Instructions of Use that come with the product.

Source page: https://510kreport.com/device/K113608
Methodology: https://510kreport.com/methodology