# K143033: Dentca Denture Base

- Pathway: 510(k) (Traditional)
- Applicant: Dentca, Inc.
- Decided: Jul 21, 2015 after 272 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: 2 generations back to K011560 (2001). 2 ancestors in all.
30 later devices descend from it; 2 cite it directly.
0 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032892: Modification to Trubyte Denture Base Resin System, Dentsply Intl. (2003) Summary page 4.

## Most influential descendants
- 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
- K203641: E-Denture Pro (2021), 3 descendants of its own

## Indications for use
Dentca Denture Base is a light-cured resin indicated for fabrication and repair of full and partial removable dentures and baseplates. The material is an alternative to traditional heat-cured and auto polymerizing resins. Fabrication of dental prosthetics with Dentca Denture Base requires a computer-aided design and manufacturing (CAD/CAM) system that includes the following components not part of the device: oral casting impression, digital denture base file created in an optical impression system, stereolithographic additive printer, and curing light equipment.

Source page: https://510kreport.com/device/K143033
Methodology: https://510kreport.com/methodology