# K013542: Dentin Conditioning and Adhesive System (Bond-1)

- Pathway: 510(k) (Traditional)
- Applicant: Jeneric/Pentron, Inc.
- Decided: Feb 14, 2002 after 120 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 K973388 (1997). 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)
- K973388: Dentin Conditioning and Adhesive (Bond 1), Jeneric/Pentron, Inc. (1997) Summary page 1.

## Indications for use
Dentin Conditioning and Adhesive System (Bond-1) is used for adhesion to Dentin of various polymeric filling materials (composites) used with other conditioners or combination of conditioners for bonding of composite to metal including amalgam, gold, semi precious and non precious alloys, porcelain and glass and luting of same to dentin and enamel.

Source page: https://510kreport.com/device/K013542
Methodology: https://510kreport.com/methodology