# K032892: Modification to Trubyte Denture Base Resin System

- Pathway: 510(k) (Special)
- Applicant: Dentsply Intl.
- Decided: Sep 26, 2003 after 9 days
- Product code: EBI (Resin, Denture, Relining, Repairing, Rebasing)
- Device class: 2
- Regulation: 21 CFR 872.3760
- 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 K011560 (2001). 1 ancestor in all.
35 later devices descend from it; 3 cite it directly.
0 of 37 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011560: Trubyte Denture Base Resin System, Dentsply Intl. (2001)

## Most influential descendants
- K143033: Dentca Denture Base (2015), 30 descendants of its own
- K162572: NextDent Denture, E-Denture (2017), 28 descendants of its own
- K191497: NextDent Denture 3D+ (2019), 13 descendants of its own
- K190043: Halley resin (2019), 7 descendants of its own
- K210298: GR-14 Resin System (2021), 3 descendants of its own

## Indications for use
The TrubyteO Denture Base Resin System is indicated for: 1. Fabrication of dentures. appliances and prostheses 2. Repair of dentures. appliances and prostheses 3. Relining of denture surfaces

Source page: https://510kreport.com/device/K032892
Methodology: https://510kreport.com/methodology