# K101771: Reline-IT Model Reline-IT

- Pathway: 510(k) (Traditional)
- Applicant: Majestic Drug Co., Inc.
- Decided: Sep 20, 2010 after 88 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: 1 generation back to K790589 (1979). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K790589: Denture-Tight, Den-Mat Corp. (1979) Summary page 2.
- (no number) Acryline 2: named in the summary without a submission number
- (no number) Perma Soft II: named in the summary without a submission number

## Most influential descendants
- K121318: Prosoft (2012), 0 descendants of its own

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

Source page: https://510kreport.com/device/K101771
Methodology: https://510kreport.com/methodology