# K982394: Prime & Bond NT Dual Cure Universal Dental Adhesive System

- Pathway: 510(k) (Traditional)
- Applicant: Dentsply Intl.
- Decided: Sep 21, 1998 after 74 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: 4 generations back to K931812 (1993). 7 ancestors in all.
22 later devices descend from it; 8 cite it directly.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K962348: Prime & Bond 2.1 Multipurpose Dentin/Enamel Bonding Agent, Dentsply Intl. (1996) Summary page 1.
- K964525: Prime & Bond 2.1 M.P. Dentin/Enamel Bonding Agent W/Activator, Dentsply Intl. (1997) Summary page 1.

## Most influential descendants
- K992822: Seal & Protect Protective Sealant for Exposed Dentine (1999), 9 descendants of its own
- K021805: Seal & Protect Protective Sealant (2002), 4 descendants of its own
- K023842: Clearfil SE Bond Plus (2003), 3 descendants of its own
- K023776: Xeno Iii Dental Adhesive (2003), 3 descendants of its own
- K003482: Proclude-Sensitive (2001), 3 descendants of its own

## Indications for use
Direct composite and compomer restorations Composite, ceramic and amalgam repairs Cavity varnish for use with fresh amalgam Indirect restorations: Dual Cure, inlays, onlays, veneers, crowns and bridges Endodontic post cementation Adhesive bonding of direct amalgam restorations

Source page: https://510kreport.com/device/K982394
Methodology: https://510kreport.com/methodology