# K990314: Multi-Cure Composite Cement

- Pathway: 510(k) (Traditional)
- Applicant: Medental Intl.
- Decided: Apr 2, 1999 after 60 days
- Product code: EBF (Material, Tooth Shade, Resin)
- Device class: 2
- Regulation: 21 CFR 872.3690
- 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
Multi-Cure composite cement is used as a luting cement for veneers, crowns, and bridges for anterior and posterior teeth. Composite restorative materials were developed by Dr. Raphael Bowen working for American Dental Research. The main innovation was Bisphenol A-Glycidyl Methacrylate (Bis-GMA), a dimethacrylate resin with silane coated filler (quartz) particles. These coated particles could bond chemically to the Bis~GMA resin. This is recommended for use for Classes III to V and for Class I when oclusal stress is not a problem and appearance is crucial. Although less durable than amalgam composite designed for Class II posterior applications, it is now used in about 20% of these restorations also. The base paste and catalyst paste when mixed together form an exothermic reaction. When a standard dental curing light in the visible wave-length range is used it will cause the camphorquinone and the liquid “A” dimethylaminoethyl methacrylate to accelerate this reaction.

Source page: https://510kreport.com/device/K990314
Methodology: https://510kreport.com/methodology