# K990056: Jeldent Multicryl

- Pathway: 510(k) (Traditional)
- Applicant: J.F. Jelenko & Co., Inc.
- Decided: Mar 25, 1999 after 77 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Multicryl is a dual technique resin for auto- and heat cure technique. It is used as multipurpose acrylic for pour- and presspack technique with one powder and two liquids: COLD for pour technique and HEAT for presspack technique. Cold curing: -upper and lower full dentures (pour technique) -completion of partial dentures -repairs Heat Cure: -upper and lower full dentures (presspack technique)

Source page: https://510kreport.com/device/K990056
Methodology: https://510kreport.com/methodology