# K063626: Duraflex

- Pathway: 510(k) (Traditional)
- Applicant: Cosmetic Dental Materials, Inc.
- Decided: Feb 8, 2007 after 64 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
No predicates in its family tree.
5 later devices descend from it; 4 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Lucitone FRS Flexible Dental Resin: named in the summary without a submission number

## Most influential descendants
- K250489: FP3D (2025), 1 descendant of its own
- K253365: LuxCreo Flexible Partial Denture Resin (2025), 0 descendants of its own
- K172407: Duracetal (2017), 0 descendants of its own
- K123396: I.Flex by TCS (2013), 0 descendants of its own
- K111709: Foundation Dental Resin (2011), 0 descendants of its own

## Indications for use
The DuraFlex thermoplastic resin is used for the fabrication of partial or full removable dentures, as well as occlusal splints and night guards.

Source page: https://510kreport.com/device/K063626
Methodology: https://510kreport.com/methodology