# K113788: Deflex Acrilato

- Pathway: 510(k) (Traditional)
- Applicant: Nuxen S.R.L.
- Decided: Mar 16, 2012 after 85 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 K970522 (1997). 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)
- K053060: TCS Unbreakable, Thermoplastic Comfort Systems, Inc. (2006) Summary page 1.
- K102874: New Stetic Acrylics, New Stetic (2011) Summary page 1.

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

Source page: https://510kreport.com/device/K113788
Methodology: https://510kreport.com/methodology