510(k) · Cleared
ClearedDenture Base Resin V2
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Formlabs Ohio, Inc. · EBI Resin, Denture, Relining, Repairing, Rebasing
Cleared on Jul 8, 2026 as substantially equivalent to K231578 (Dentsply Sirona, 2023) after a 1-day review. Its family tree reaches back 7 generations to 2001.
- Decided
- Jul 8, 2026
- Review
- 1 day
- Class
- Class II
- Product code
- EBI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K011560 (2001). 10 ancestors in all, the oldest K924422 (1992). No later device cites it as a predicate yet.
- Root · 7 generations backK011560 Trubyte Denture Base Resin SystemDentsply Intl. · 2001
- 6 generations backK032892 Modification to Trubyte Denture Base Resin SystemDentsply Intl. · 2003
- 5 generations backK143033 Dentca Denture BaseDentca, Inc. · 2015
- 4 generations backK162572 NextDent Denture, E-DentureVertex-Dental B.V. · 2017
- 3 generations backK190043 Halley resinDentsply Sirona · 2019
- 2 generations backK191427 Halley resin systemDentsply Sirona · 2019
- 1 generation backK231578 Lucitone Digital Print Denture SystemDentsply Sirona · 2023
- This deviceK262300 Denture Base Resin V2Formlabs Ohio, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K011560 | Trubyte Denture Base Resin System | Dentsply Intl. | 2001 | — |
| −6 | K032892 | Modification to Trubyte Denture Base Resin System | Dentsply Intl. | 2003 | — |
| −5 | K143033 | Dentca Denture Base | Dentca, Inc. | 2015 | — |
| −4 | K162572 | NextDent Denture, E-Denture | Vertex-Dental B.V. | 2017 | — |
| −3 | K190043 | Halley resin | Dentsply Sirona | 2019 | — |
| −2 | K191427 | Halley resin system | Dentsply Sirona | 2019 | — |
| −1 | K231578 | Lucitone Digital Print Denture System | Dentsply Sirona | 2023 | — |
| 0 (this device) | K262300 | Denture Base Resin V2 | Formlabs Ohio, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1998 | 1 | 0 |
| 2005 | 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 |
|---|---|---|---|
| * | K231578 | Lucitone Digital Print Denture SystemSummary page 5…r 872.3760 Product Code(s) EBI | Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K231578 Lucitone Digital Print 3D Denture Base EBI Device Description Summary 21 CFR 807.92(a)(4) Denture Base Resin V2 is a light-curab… | 2023 |
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 25 years and passes through 5 companies; a new generation was cleared every 2.2 years on median.
- None of the 10 ancestors has a recall.
- 1 other device also cites its predicate K231578.
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. 2026, 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?
Denture Base Resin V2 is a light-curable resin indicated for the fabrication of denture bases, including full and partial removable dentures, implant overdentures, and other dental appliances. Denture Base Resin V2 is indicated to treat patients with complete or partial edentulism.
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/K262300 · printed Nov 6, 2026
Cite this page
510(k) Report. “K262300: Denture Base Resin V2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K262300
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026