510(k) · Cleared
ClearedNextDent Denture, E-Denture
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vertex-Dental B.V. · EBI Resin, Denture, Relining, Repairing, Rebasing
Cleared on Jun 30, 2017 as substantially equivalent to K143033 (Dentca, Inc., 2015) after a 288-day review. Its family tree reaches back 3 generations to 2001. 28 later devices descend from it.
- Decided
- Jun 30, 2017
- Review
- 288 days
- Class
- Class II
- Product code
- EBI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K011560 (2001). 28 later devices descend from it, 5 citing it directly.
- Root · 3 generations backK011560 Trubyte Denture Base Resin SystemDentsply Intl. · 2001
- 2 generations backK032892 Modification to Trubyte Denture Base Resin SystemDentsply Intl. · 2003
- 1 generation backK143033 Dentca Denture BaseDentca, Inc. · 2015
- This deviceK162572 NextDent Denture, E-DentureVertex-Dental B.V. · 2017
- Descendant · cites it directly · 13 of its ownK191497 NextDent Denture 3D+Vertex-Dental B.V. · 2019
- Descendant · cites it directly · 7 of its ownK190043 Halley resinDentsply Sirona · 2019
- Descendant · 2 generations on · 3 of its ownK210298 GR-14 Resin SystemPro3Dure Medical GmbH · 2021
- Descendant · 2 generations on · 3 of its ownK203641 E-Denture ProEnvisiontec GmbH · 2021
- Descendant · cites it directly · 3 of its ownK200461 Freeprint dentureDetax GmbH & Co. KG · 2020
Showing 5 of 28 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 28 · See all- K191497NextDent Denture 3D+Vertex-Dental B.V. · 2019 · cites it directly13descendants
- K190043Halley resinDentsply Sirona · 2019 · cites it directly7descendants
- K210298GR-14 Resin SystemPro3Dure Medical GmbH · 2021 · 2 generations on3descendants
- K203641E-Denture ProEnvisiontec GmbH · 2021 · 2 generations on3descendants
- K200461Freeprint dentureDetax GmbH & Co. KG · 2020 · cites it directly3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K011560 | Trubyte Denture Base Resin System | Dentsply Intl. | 2001 | — |
| −2 | K032892 | Modification to Trubyte Denture Base Resin System | Dentsply Intl. | 2003 | — |
| −1 | K143033 | Dentca Denture Base | Dentca, Inc. | 2015 | — |
| 0 (this device) | K162572 | NextDent Denture, E-Denture | Vertex-Dental B.V. | 2017 | — |
| +1 | K191497 | NextDent Denture 3D+ | Vertex-Dental B.V. | 2019 | — |
| +1 | K190043 | Halley resin | Dentsply Sirona | 2019 | — |
| +2 | K210298 | GR-14 Resin System | Pro3Dure Medical GmbH | 2021 | — |
| +2 | K203641 | E-Denture Pro | Envisiontec GmbH | 2021 | — |
| +1 | K200461 | Freeprint denture | Detax GmbH & Co. KG | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2019 | 3 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 4 | 0 |
| 2024 | 5 | 0 |
| 2025 | 6 | 0 |
| 2026 | 4 | 0 |
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 |
|---|---|---|---|
| * | K143033 | Dentca Denture BaseSummary page 4…sification #: 21 CFR 872.3760 Product Code EBI Regulatory Class 2 III. PREDICATE DEVICE(s) Dentca Denture Base, K143033 No reference devices were used in this submission. IV. DEVICE DESCRIPTION Device I… | 2015 |
What descends from it? (28)
See all 285 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 16 years and passes through 3 companies; a new generation was cleared every 2.2 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K191497 (Vertex-Dental B.V., 2019) has gone furthest, with 13 descendants of its own.
- 1 other device also cites its predicate K143033.
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. 2017, 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?
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…
Read the full statement (130 words)
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
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/K162572 · printed Nov 5, 2026
Cite this page
510(k) Report. “K162572: NextDent Denture, E-Denture.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K162572
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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