# K242897: Partial Flex

- Pathway: 510(k) (Traditional)
- Applicant: Clemde SA DE CV
- Decided: Jun 3, 2025 after 253 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.
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)
- K053060: TCS Unbreakable, Thermoplastic Comfort Systems, Inc. (2006) Summary page 5.

## Indications for use
Partial Flex® is indicated for the fabrication of partial or full removable dentures, as well oclusional

Source page: https://510kreport.com/device/K242897
Methodology: https://510kreport.com/methodology