# K092501: Light-Activated Low-Stress Thiol-Ene Composite Restorative Material

- Pathway: 510(k) (Abbreviated)
- Applicant: Novocol, Inc.
- Decided: Nov 12, 2009 after 90 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
"Light-Activated Low-Stress Thiol-Ene Composite Restorative Material" is a light Cure restorative material indicated for direct esthetic restoration of anterior and posterior teeth. It provides easy esthetics since it is formulated in shades matching the VITA Lumin® Shade guide. This low stress nanohybrid composite can be used in all classes of direct dental restorations, Class 1,11, III, IV,and V. It may also be used for dental core build-ups

Source page: https://510kreport.com/device/K092501
Methodology: https://510kreport.com/methodology