# K992879: Ecusit Composite Repair

- Pathway: 510(k) (Traditional)
- Applicant: Dmg Hamburg
- Decided: Nov 9, 1999 after 75 days
- Product code: KLE (Agent, Tooth Bonding, Resin)
- Device class: 2
- Regulation: 21 CFR 872.3200
- 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 K974906 (1998). 1 ancestor in all.
2 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K974906: One Coat Bond Dentin/Enamel Adhesive System, Coltene/Whaledent, Inc. (1998) Summary page 1.

## Most influential descendants
- K041960: Composite/Compomer Repair Kit (2004), 1 descendant of its own
- K063444: Total Etch Bonding Agent (2007), 0 descendants of its own

## Indications for use
Ecusit Composite Repair is indicated for intra-oral repair of composite restorations.

Source page: https://510kreport.com/device/K992879
Methodology: https://510kreport.com/methodology