# K120767: ES Bond

- Pathway: 510(k) (Traditional)
- Applicant: Spident Co., Ltd.
- Decided: May 24, 2012 after 71 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 K945604 (1995). 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)
- K945604: Ecliptomer, Bisco, Inc. (1995) Summary page 1.

## Indications for use
All Direct Composite Restorations Directed Shrinkage Composite Restorations Desensitization of Crown Preparations Prior to Impression Making/Provisionalization Composite Core Build-Ups Composite to Composite (Repair) Composite to Metal/Set Amalgam (Direct Veneering) Root Desensitization

Source page: https://510kreport.com/device/K120767
Methodology: https://510kreport.com/methodology