# K013519: Simple

- Pathway: 510(k) (Traditional)
- Applicant: Bisco, Inc.
- Decided: Jan 17, 2002 after 86 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: 6 generations back to K931812 (1993). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K990040: Clearfil SE Bond, Kuraray Co. (1999) Summary page 1.

## Indications for use
1. Direct and Indirect Restorations: to etch enamel/dentin prior to bonding with ONE-Step and some other fifth generation adhesives for use with light-cured composite materials 2. Indirect Restorations: when used with an adhesive, to seal a preparation when using a light-cured composite cement. 3. Densensitization: when uscd in combination with adhesive, to treat hypemnsitive and/or exposed root surfaces.

Source page: https://510kreport.com/device/K013519
Methodology: https://510kreport.com/methodology