# K050386: Prime & Bond NT Dual Cure Nano-Technology Universal Dental Adhesive System

- Pathway: 510(k) (Special)
- Applicant: Dentsply International
- Decided: Feb 23, 2005 after 8 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.
4 later devices descend from it; 3 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

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

## Most influential descendants
- K051463: Xeno Adhesive with Activator (2005), 1 descendant of its own
- K151619: Prime&Bond Elect Universal Dental Adhesive (2015), 0 descendants of its own
- K131430: Clearfil DC Activator; Clearfil DC Activator Trial (2013), 0 descendants of its own
- K070538: XP Bond Dual Cure Universal Total Etch Adhesive (2007), 0 descendants of its own

Source page: https://510kreport.com/device/K050386
Methodology: https://510kreport.com/methodology