# K120237: Bpa-Free Microhybid Composite

- Pathway: 510(k) (Abbreviated)
- Applicant: Novocol, Inc.
- Decided: Dec 11, 2012 after 320 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
Microhybid Composite is indicated for direct esthetic restoration in the anterior and posterior regions. This composite can be used in all direct dental restorations, Class I, 11, III, IV,and V, and diastema closure. Microhybrid Composite Is indicated for direct esthetic restoration in the anterior and posterior regions. This composite can be used in all direct dental restorations, Class 1,11, Ill, IV,and V, and diastema closure.

Source page: https://510kreport.com/device/K120237
Methodology: https://510kreport.com/methodology