# K151619: Prime&Bond Elect Universal Dental Adhesive

- Pathway: 510(k) (Traditional)
- Applicant: Dentsply International, Inc.
- Decided: Oct 30, 2015 after 136 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: 7 generations back to K931812 (1993). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051463: Xeno Adhesive with Activator, Dentsply Intl. (2005) Summary page 4.

## Indications for use
1. Prime&Bond Elect® Universal Dental Adhesive (visible light cured): 1.1 Direct, light cured composite and compomer restorations 1.2 Indirect restorations; light cured, resin cemented veneers 1.3 Indirect restorations; acid-tolerant resin cement (dual cure or self-cure) cemented inlays, onlays, crown and bridge retainers 1.4 Composite, ceramic and amalgam repairs 1.5 Cavity varnish for use with fresh amalgam 2. Prime&Bond Elect® Universal Dental Adhesive mixed with Self-Cure Activator (dual cure or self-cure): 2.1 Direct, dual cure or self-cure composite restorations and core build-ups 2.2 Indirect restorations; dual cured and self-cured resin cemented inlays, onlays, crown and bridge retainers 2.3 Dual cured and self-cured resin cemented endodontic post cementation 3. Prime&Bond Elect® Universal Dental Adhesive mixed with Self-Cure Activator and Amalgam Bonding Base & Catalyst: 3.1 Adhesive bonding of direct amalgam restoration 4. Prime&Bond Elect® Universal Dental Adhesive (without Self-Cure Activator or adhesive curing): 4.1 Indirect restorations; acid-tolerant resin cement light-cured cementation; light transmissible inlays, onlays, crown and bridge retainers with light curing of cement 4.2 Indirect restorations; acid-tolerant resin cement dual cure or self-cure cementation; limited light/light opaque inlays, onlays, crown and bridge retainers and endodontic posts with total etch technique

Source page: https://510kreport.com/device/K151619
Methodology: https://510kreport.com/methodology