# K964040: Trubyte Soft Reline System

- Pathway: 510(k) (Traditional)
- Applicant: Dentsply Intl.
- Decided: Dec 6, 1996 after 59 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: 1 generation back to K901621 (1990). 2 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K901621: New Per-Fit (R) Improved, Dental Product Co. (1990) Summary page 1.
- K933468: Myerson's Permasoft Soft Reline Material, Austenal, Inc. (1994) Summary page 1.
- (no number) Molloplast B: named in the summary without a submission number

## Most influential descendants
- K140146: Comfortsoft Soft Denture Liner System (2014), 0 descendants of its own
- K983357: Mucopren Soft Relining System (1998), 0 descendants of its own

## Indications for use
The TRUBYTE® SOFT RELINE SYSTEM is for use as a long-term resilient lining material for removable dentures.

Source page: https://510kreport.com/device/K964040
Methodology: https://510kreport.com/methodology