# K123396: I.Flex by TCS

- Pathway: 510(k) (Traditional)
- Applicant: Thermoplastic Comfort Systems, Inc.
- Decided: Jan 10, 2013 after 66 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
i.flex by TCS is a thermoplastic resin used for the fabrication of partial or full removable dentures, as well as occlusal splints and night guards.

Source page: https://510kreport.com/device/K123396
Methodology: https://510kreport.com/methodology