# K181220: Juell 3D Volo Base

- Pathway: 510(k) (Traditional)
- Applicant: Park Dental Research Corporation
- Decided: Oct 12, 2018 after 158 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.
No later device cites it as a predicate yet.
0 of 5 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.

## Indications for use
Juell 3D Volo Base 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. Juell 3D Volo Base is intended exclusively for professional dental work. Fabrication of denture bases with Juell 3D Volo Base requires a computer-aided and manufacturing (CAD/CAM) system that includes the following: scanner, design software, additive printer and post-cure unit. Juell 3D Volo Base is compatible with the following CAD/CAM systems components: Design Brand Type Scanner Dental Wings I series Design Software Dental Wings DWOS Printing Brand Type Software Printer Juell 3D DLP Flash OC Post-Curing Brand Type Post-Cure Unit ~ Juell 3D Cure Cube 360

Source page: https://510kreport.com/device/K181220
Methodology: https://510kreport.com/methodology