# K973388: Dentin Conditioning and Adhesive (Bond 1)

- Pathway: 510(k) (Traditional)
- Applicant: Jeneric/Pentron, Inc.
- Decided: Sep 12, 1997 after 3 days
- Product code: KLE (Agent, Tooth Bonding, Resin)
- Device class: 2
- Regulation: 21 CFR 872.3200
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
6 later devices descend from it; 4 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K994359: Bond 1 C & B (2000), 2 descendants of its own
- K013543: Bond-1 C & B (2002), 1 descendant of its own
- K122522: Dentoetch Quickbond Bond Activator (2013), 0 descendants of its own
- K111431: B1P Adhesive (2011), 0 descendants of its own
- K013542: Dentin Conditioning and Adhesive System (Bond-1) (2002), 0 descendants of its own

## Recalls of this device
- May 27, 2010 · Not classified · Z-1142-2012: The recall was initiated because Pentron Clinical has confirmed that various lots of Bond-1 Primer/Adhesive have been found to have gelled and therefore becomes unusable.
- Aug 24, 2009 · Not classified · Z-1150-2010: Some of the material has been found to be gelled and therefore becomes unusable.

## Indications for use
Adhesion to Dentin and 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/K973388
Methodology: https://510kreport.com/methodology