# K951864: Prime & Bond Direct Composite Bonding Agent

- Pathway: 510(k) (Traditional)
- Applicant: Dentsply Intl.
- Decided: May 23, 1995 after 32 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
No predicates in its family tree.
129 later devices descend from it; 2 cite it directly.
0 of 130 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K960823: Prime & Bond 2.0 Multipurpose Dentin/Enamel Bonding Agent (1996), 90 descendants of its own
- 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

Source page: https://510kreport.com/device/K951864
Methodology: https://510kreport.com/methodology