# K994359: Bond 1 C & B

- Pathway: 510(k) (Traditional)
- Applicant: Jeneric/Pentron, Inc.
- Decided: Mar 21, 2000 after 85 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.
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)
- K973388: Dentin Conditioning and Adhesive (Bond 1), Jeneric/Pentron, Inc. (1997) Summary page 1.

## Most influential descendants
- K013543: Bond-1 C & B (2002), 1 descendant of its own
- K122522: Dentoetch Quickbond Bond Activator (2013), 0 descendants of its own

## Indications for use
Bond 1 C & B is used for adhesion to dentin and bonding of various polymeric filling materials (composites). Also, Bond 1 C & B is used 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/K994359
Methodology: https://510kreport.com/methodology