510(k) · Cleared
ClearedJuell 3D Volo Base
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Park Dental Research Corporation · EBI Resin, Denture, Relining, Repairing, Rebasing
Cleared on Oct 12, 2018 as substantially equivalent to K162572 (Vertex-Dental B.V., 2017) after a 158-day review. Its family tree reaches back 4 generations to 2001.
- Decided
- Oct 12, 2018
- Review
- 158 days
- Class
- Class II
- Product code
- EBI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K011560 (2001). No later device cites it as a predicate yet.
- Root · 4 generations backK011560 Trubyte Denture Base Resin SystemDentsply Intl. · 2001
- 3 generations backK032892 Modification to Trubyte Denture Base Resin SystemDentsply Intl. · 2003
- 2 generations backK143033 Dentca Denture BaseDentca, Inc. · 2015
- 1 generation backK162572 NextDent Denture, E-DentureVertex-Dental B.V. · 2017
- This deviceK181220 Juell 3D Volo BasePark Dental Research Corporation · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K011560 | Trubyte Denture Base Resin System | Dentsply Intl. | 2001 | — |
| −3 | K032892 | Modification to Trubyte Denture Base Resin System | Dentsply Intl. | 2003 | — |
| −2 | K143033 | Dentca Denture Base | Dentca, Inc. | 2015 | — |
| −1 | K162572 | NextDent Denture, E-Denture | Vertex-Dental B.V. | 2017 | — |
| 0 (this device) | K181220 | Juell 3D Volo Base | Park Dental Research Corporation | 2018 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in EBI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new EBI device
- #1 K250617 Apex Flexscore 18.3 · 1 generation · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K162572 | NextDent Denture, E-DentureSummary page 4…olo Base Common Name: Denture Base Product Code: EBI Regulation No.: 872.3760 Denture Relining, Repairing or Rebasing Resin Classification: Class II Predicate 510k: K162572 NextDent Denture/E-Denture from Vertex-Dental BV Device Description: Juell 3D Volo Base 3D-printing material is a light-cured r… | 2017 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 17 years and passes through 4 companies; a new generation was cleared every 2.2 years on median.
- None of the 4 ancestors has a recall.
- 4 other devices also cite its predicate K162572.
How does its category compare?
All EBI devicesEBI Resin, Denture, Relining, Repairing, Rebasing: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · EBI
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EBI
79in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EBI
2in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EBI
34in 2025
MAUDE reports naming product code EBI, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 10 | 53 | 0 | 7 |
| 2008 | 6 | 124 | 0 | 2 |
| 2009 | 3 | 234 | 0 | 5 |
| 2010 | 4 | 95 | 0 | 4 |
| 2011 | 11 | 113 | 0 | 6 |
| 2012 | 3 | 85 | 0 | 9 |
| 2013 | 5 | 135 | 0 | 5 |
| 2014 | 5 | 102 | 0 | 9 |
| 2015 | 9 | 106 | 0 | 8 |
| 2016 | 7 | 147 | 0 | 9 |
| 2017 | 8 | 196 | 0 | 2 |
| 2018 | 5 | 158 | 2 | 2 |
| 2019 | 4 | 127 | 0 | 10 |
| 2020 | 6 | 283 | 0 | 8 |
| 2021 | 4 | 99 | 0 | 25 |
| 2022 | 11 | 154 | 2 | 2 |
| 2023 | 11 | 96 | 0 | 13 |
| 2024 | 9 | 90 | 0 | 1 |
| 2025 | 11 | 79 | 0 | 34 |
| 2026 | 7 | 87 | 0 | — |
What is it indicated for?
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…
Read the full statement (123 words)
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
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K181220 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181220: Juell 3D Volo Base.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181220
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026