# K140146: Comfortsoft Soft Denture Liner System

- Pathway: 510(k) (Traditional)
- Applicant: Whip Mix Corp.
- Decided: Apr 29, 2014 after 97 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: 2 generations back to K901621 (1990). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K964040: Trubyte Soft Reline System, Dentsply Intl. (1996) Summary page 2.

## Indications for use
The ComfortSoft' Soft Denture Liner System Is Intended for use as a long-term soft liner for removable dentures

Source page: https://510kreport.com/device/K140146
Methodology: https://510kreport.com/methodology