# K121318: Prosoft

- Pathway: 510(k) (Traditional)
- Applicant: Perma Laboratories
- Decided: Jun 6, 2012 after 35 days
- Product code: EBP (Reliner, Denture, Over The Counter)
- Device class: 2
- Regulation: 21 CFR 872.3560
- 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 K790589 (1979). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101771: Reline-IT Model Reline-IT, Majestic Drug Co., Inc. (2010) Summary page 1.

## Indications for use
An over the counter temporary Denture Reliner, intended to replace a worn denture lining.

Source page: https://510kreport.com/device/K121318
Methodology: https://510kreport.com/methodology