# K191497: NextDent Denture 3D+

- Pathway: 510(k) (Abbreviated)
- Applicant: Vertex-Dental B.V.
- Decided: Nov 1, 2019 after 149 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: 4 generations back to K011560 (2001). 4 ancestors in all.
13 later devices descend from it; 6 cite it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162572: NextDent Denture, E-Denture, Vertex-Dental B.V. (2017) Summary page 4.

## Most influential descendants
- K210298: GR-14 Resin System (2021), 3 descendants of its own
- K203641: E-Denture Pro (2021), 3 descendants of its own
- K241089: KeyPrint KeyDenture Base (2024), 2 descendants of its own
- K213765: Glidewell 3DP Denture Base Resin (2022), 2 descendants of its own
- K250489: FP3D (2025), 1 descendant of its own

## Indications for use
NextDent Denture 3D+ 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 3D+ is intended exclusively for professional dental work. Fabrication of denture bases with NextDent Denture 3D+ requires a computer-aided and manufacturing (CAD/CAM) system that includes the following scanner, design software, additive printer and post-cure unit: Design: Brand Type Software Scanner 3Shape D900 Design software 3Shape Dental-System 2016 Premium Printing: Brand Type Software Printer 3D Systems NextDent 5100 Figure4® 3D Sprint Post-curing: Brand Type Software Post-cure unit NextDent LC-3DPrint Box n.a.

Source page: https://510kreport.com/device/K191497
Methodology: https://510kreport.com/methodology