# K992518: Prime & Bond NT Dual Cure Universal Dental Adhesive System

- Pathway: 510(k) (Traditional)
- Applicant: Dentsply Intl.
- Decided: Sep 22, 1999 after 56 days
- Product code: EBC (Sealant, Pit And Fissure, And Conditioner)
- Device class: 2
- Regulation: 21 CFR 872.3765
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K931812 (1993). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982394: Prime & Bond NT Dual Cure Universal Dental Adhesive System, Dentsply Intl. (1998) Summary page 1.

## Indications for use
Addition of New Indication: To be used in conjunction with pit and fissure sealant Current Indications, K982394: Direct composite and compomer restorations Composite, ceramic and amalgam repairs Cavity vamish for use with fresh amalgam Indirect restorations: Dual Cure, inlays, onlays, veneers, crowns and bridges Endaodontic post cementation Adhesive bonding of direct amalgam restorations

Source page: https://510kreport.com/device/K992518
Methodology: https://510kreport.com/methodology