# K983357: Mucopren Soft Relining System

- Pathway: 510(k) (Traditional)
- Applicant: Roydent Dental Products, Inc.
- Decided: Nov 13, 1998 after 50 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). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 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 1.
- K953589: Tokuyama Soft Relining, Tokuyama America, Inc. (1996) Summary page 1.
- K963736: Soft Denture Rebasing Resin, Sybron Dental Specialties, Inc. (1996) Summary page 1.
- K954810: Myerson IR Denture Base, Austenal, Inc. (1995) Summary page 1.

## Indications for use
Intended for use as a long-term resilient lining material for removable dentures, to reline, repair, or rebase dentures.

Source page: https://510kreport.com/device/K983357
Methodology: https://510kreport.com/methodology