# K231388: NextDent Base

- Pathway: 510(k) (Abbreviated)
- Applicant: Vertex-Dental B.V.
- Decided: Oct 20, 2023 after 161 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: 5 generations back to K011560 (2001). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191497: NextDent Denture 3D+, Vertex-Dental B.V. (2019) Summary page 5.

## Most influential descendants
- K241071: NextDent Jet Denture Base; NextDent Jet Denture Teeth (2024), 0 descendants of its own

## Indications for use
NextDent Base is for dental professional use only and intended for the manufacturing of denture bases to support artificial teeth to form full or partial removable dentures.

Source page: https://510kreport.com/device/K231388
Methodology: https://510kreport.com/methodology