# K240112: Light Cure Composite

- Pathway: 510(k) (Traditional)
- Applicant: Sincera Technology (Changchun) Co., Ltd.
- Decided: Mar 15, 2024 after 59 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
Longest line of descent: 1 generation back to K042819 (2004). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042819: Tetric Evoceram, Ivoclar Vivadent, Inc. (2004) Summary page 5.

## Indications for use
Anterior restorations (Class III, IV) Class V restorations (cervical caries, root erosion, wedge-shaped defects) Restorations in the posterior region (Class I and II) Veneering of discolored anterior teeth Splinting of mobile teeth Repair of composite and ceramic veneers

Source page: https://510kreport.com/device/K240112
Methodology: https://510kreport.com/methodology