# K110428: ESCOM 100

- Pathway: 510(k) (Traditional)
- Applicant: Spident Co., Ltd.
- Decided: Feb 25, 2011 after 11 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: 3 generations back to K002863 (2001). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080940: Estelite Sigma Quick, Tokuyama Dental Corporation (2008) Summary page 1.

## Indications for use
EsCom 100 is a light curing, radiopaque composite filling material for use in anterior and posterior restorations and is indicated for all carious classes.

Source page: https://510kreport.com/device/K110428
Methodology: https://510kreport.com/methodology