510(k) · Cleared
ClearedNextDent Base
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 Oct 20, 2023 as substantially equivalent to K191497 (Vertex-Dental B.V., 2019) after a 161-day review. Its family tree reaches back 5 generations to 2001. 1 later device descends from it.
- Decided
- Oct 20, 2023
- Review
- 161 days
- Class
- Class II
- Product code
- EBI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K011560 (2001). 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK011560 Trubyte Denture Base Resin SystemDentsply Intl. · 2001
- 4 generations backK032892 Modification to Trubyte Denture Base Resin SystemDentsply Intl. · 2003
- 3 generations backK143033 Dentca Denture BaseDentca, Inc. · 2015
- 2 generations backK162572 NextDent Denture, E-DentureVertex-Dental B.V. · 2017
- 1 generation backK191497 NextDent Denture 3D+Vertex-Dental B.V. · 2019
- This deviceK231388 NextDent BaseVertex-Dental B.V. · 2023
- Descendant · cites it directly · 0 of its ownK241071 NextDent Jet Denture Base; NextDent Jet Denture TeethVertex-Dental B.V. · 2024
Most influential descendants
Showing 1 of 1 · See all- K241071NextDent Jet Denture Base; NextDent Jet Denture TeethVertex-Dental B.V. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K011560 | Trubyte Denture Base Resin System | Dentsply Intl. | 2001 | — |
| −4 | K032892 | Modification to Trubyte Denture Base Resin System | Dentsply Intl. | 2003 | — |
| −3 | K143033 | Dentca Denture Base | Dentca, Inc. | 2015 | — |
| −2 | K162572 | NextDent Denture, E-Denture | Vertex-Dental B.V. | 2017 | — |
| −1 | K191497 | NextDent Denture 3D+ | Vertex-Dental B.V. | 2019 | — |
| 0 (this device) | K231388 | NextDent Base | Vertex-Dental B.V. | 2023 | — |
| +1 | K241071 | NextDent Jet Denture Base; NextDent Jet Denture Teeth | Vertex-Dental B.V. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 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 |
|---|---|---|---|
| * | K191497 | NextDent Denture 3D+Summary page 5…Classification 21 CFR 872.3760 Regulation III. PREDICATE NextDent Denture 3D+, K191497 (Primary Predicate) DEVICE(s) IV. DEVICE DESCRIPTION Device Identification: Light-Cure Resin, provided in a container.… | 2019 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K241071 | NextDent Jet Denture Base; NextDent Jet Denture Teeth | 2024 | 0 |
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 22 years and passes through 3 companies; a new generation was cleared every 2.3 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K241071 (Vertex-Dental B.V., 2024) has gone furthest, with 0 descendants of its own.
- 5 other devices also cite its predicate K191497.
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. 2023, 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 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K231388 · printed Nov 6, 2026
Cite this page
510(k) Report. “K231388: NextDent Base.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K231388
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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