# K081537: CFS Flexible

- Pathway: 510(k) (Traditional)
- Applicant: Comfort and Flexible Systems
- Decided: Jan 22, 2009 after 234 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.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K053006: Rossmax Digital Sphygmomanometer Mandaus II, Rossmax Internationl, Ltd. (2006). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Indications for use
CFS FLEXIBLE™ is a break resistant material used in the fabrication and repair of base plates for removable dental prosthetic appliances where superior flexibility and patient comfort for the lifetime of the prosthetic are significant concerns. This includes, but not limited to, full and partial dentures, orthodontic devices, occlusal splints, and night guards.

Source page: https://510kreport.com/device/K081537
Methodology: https://510kreport.com/methodology