# K982191: Chemical Cure Composite with Enamel Bond

- Pathway: 510(k) (Traditional)
- Applicant: Medental Intl.
- Decided: Sep 14, 1998 after 84 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
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. Enamel bonding is usually performed when composite restoration is required. The surfaces are acid-etched to allow the resin to penetrate into the microporosity, polymerized, and form resin “tags” that are mechanically bonded to the enamel.

Source page: https://510kreport.com/device/K982191
Methodology: https://510kreport.com/methodology