# K011560: Trubyte Denture Base Resin System

- Pathway: 510(k) (Traditional)
- Applicant: Dentsply Intl.
- Decided: Jul 12, 2001 after 52 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
No predicates in its family tree.
37 later devices descend from it; 3 cite it directly.
0 of 38 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K032892: Modification to Trubyte Denture Base Resin System (2003), 35 descendants of its own
- 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

Source page: https://510kreport.com/device/K011560
Methodology: https://510kreport.com/methodology