# K162572: NextDent Denture, E-Denture

- Pathway: 510(k) (Traditional)
- Applicant: Vertex-Dental B.V.
- Decided: Jun 30, 2017 after 288 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: 3 generations back to K011560 (2001). 3 ancestors in all.
28 later devices descend from it; 5 cite it directly.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143033: Dentca Denture Base, Dentca, Inc. (2015) Summary page 4.

## Most influential descendants
- 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
- K200461: Freeprint denture (2020), 3 descendants of its own

## Indications for use
NextDent™ Denture / E-Denture is a light-cured resin indicated for the fabrication of denture bases fabricated in dental laboratories, including full and partial removable dentures. The material is an alternative to traditional heat cured and auto polymerization resins. NextDent™ Denture / E-Denture is intended exclusively for professional dental work. Fabrication of denture bases with NextDent™ Denture / E-Denture requires a computer-aided and manufacturing (CAD/CAM) system that includes the following; scanner, design software, additive printer, and post-cure unit. NextDent™ Denture / E-Denture is compatible with the following CAD/CAM systems components: Design: Brand Type Scanner 3Shape D900 Design software 3Shape Dental-System 2016-Premium Printing: Printer Brand Type Software EnvisionTEC DDDP 4 Perfactory Rapidshape D30 NetFabb Miicraft 125Y MiiUtility MiiController 3D systems Figure 4 3D Sprint Roland DG DWP-80S Ver1.1 Post-Curing: NextDent LC-3DPrint Box

Source page: https://510kreport.com/device/K162572
Methodology: https://510kreport.com/methodology