# K982007: Trubyte Denture Bond Denture Bonding Agent

- Pathway: 510(k) (Traditional)
- Applicant: Dentsply Intl.
- Decided: Jul 22, 1998 after 44 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: 1 generation back to K924422 (1992). 1 ancestor in all.
5 later devices descend from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K924422: Palabond, Heraeus Kulzer, Inc. (1992) Summary page 1.

## Most influential descendants
- K051707: Eclipse Bonding Agent (2005), 4 descendants of its own
- K231578: Lucitone Digital Print Denture System (2023), 2 descendants of its own
- K262300: Denture Base Resin V2 (2026), 0 descendants of its own
- K243336: Lucitone Digital Print Denture™ System (2024), 0 descendants of its own
- K180917: GC Acrylic Primer (2018), 0 descendants of its own

## Indications for use
TRUBYTE® DENTURE BOND Denture Bonding Agent is used to bond plastic denture teeth and denture reline materials to acrylic denture bases.

Source page: https://510kreport.com/device/K982007
Methodology: https://510kreport.com/methodology