# K960823: Prime & Bond 2.0 Multipurpose Dentin/Enamel Bonding Agent

- Pathway: 510(k) (Traditional)
- Applicant: Dentsply Intl.
- Decided: Apr 26, 1996 after 57 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 K931812 (1993). 2 ancestors in all.
90 later devices descend from it; 2 cite it directly.
0 of 93 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K931812: New Dentine Adhesive, Dentsply Intl. (1993) Summary page 1.
- K951864: Prime & Bond Direct Composite Bonding Agent, Dentsply Intl. (1995) Summary page 1.

## Most influential descendants
- K962348: Prime & Bond 2.1 Multipurpose Dentin/Enamel Bonding Agent (1996), 89 descendants of its own
- K964525: Prime & Bond 2.1 M.P. Dentin/Enamel Bonding Agent W/Activator (1997), 86 descendants of its own
- K974486: Clearfil Liner Bond  2V (1998), 67 descendants of its own
- K990040: Clearfil SE Bond (1999), 64 descendants of its own
- K012442: Modification to Clearfil SE Bond (2001), 60 descendants of its own

## Indications for use
PRIME & BOND™ 2.0 MULTIPURPOSE DENTIN/ENAMEL BONDING AGENT is a self-priming bonding agent for use in direct and indirect restorative procedures, for adhesive repairs of amalgams, porcelain/metal and composite, and for an adhesive cavity varnish.

Source page: https://510kreport.com/device/K960823
Methodology: https://510kreport.com/methodology