# K111709: Foundation Dental Resin

- Pathway: 510(k) (Traditional)
- Applicant: Unix-Japan Co., Ltd.
- Decided: Nov 18, 2011 after 151 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 K063626 (2007). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063626: Duraflex, Cosmetic Dental Materials, Inc. (2007) Summary page 1.

## Indications for use
Foundation Dental Resin is intended for use by a qualified/trained dentists or dental laboratory technicians on dental plates for dentures (false teeth), temporary crowns, artificial teeth and orthodontic devices.

Source page: https://510kreport.com/device/K111709
Methodology: https://510kreport.com/methodology