510(k) · Cleared
ClearedFP3D
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Keystone Industries · EBI Resin, Denture, Relining, Repairing, Rebasing
Cleared on May 20, 2025 as substantially equivalent to K241089 (Keystone Industries, 2024) and 1 other predicate after a 90-day review. Its family tree reaches back 7 generations to 2001. 1 later device descends from it.
- Decided
- May 20, 2025
- Review
- 90 days
- Class
- Class II
- Product code
- EBI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K011560 (2001). 8 ancestors in all. 1 later device descends from it, 1 citing it directly.
- 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 backK191497 NextDent Denture 3D+Vertex-Dental B.V. · 2019
- 2 generations backK203641 E-Denture ProEnvisiontec GmbH · 2021
- 1 generation backK241089 KeyPrint KeyDenture BaseKeystone Industries · 2024
- This deviceK250489 FP3DKeystone Industries · 2025
- Descendant · cites it directly · 0 of its ownK253365 LuxCreo Flexible Partial Denture ResinLuxCreo, Inc. · 2025
Most influential descendants
Showing 1 of 1 · See all- K253365LuxCreo Flexible Partial Denture ResinLuxCreo, Inc. · 2025 · cites it directly0descendants
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 | K191497 | NextDent Denture 3D+ | Vertex-Dental B.V. | 2019 | — |
| −2 | K203641 | E-Denture Pro | Envisiontec GmbH | 2021 | — |
| −1 | K241089 | KeyPrint KeyDenture Base | Keystone Industries | 2024 | — |
| 0 (this device) | K250489 | FP3D | Keystone Industries | 2025 | — |
| +1 | K253365 | LuxCreo Flexible Partial Denture Resin | LuxCreo, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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? (2)
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.
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 |
|---|---|---|---|
| K253365 | LuxCreo Flexible Partial Denture Resin | 2025 | 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 24 years and passes through 5 companies; a new generation was cleared every 2.2 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K253365 (LuxCreo, Inc., 2025) has gone furthest, with 0 descendants of its own.
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. 2025, 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?
FP3D is a dual cure resin indicated for the 3D printed fabrication of flexible partial dentures in dental laboratories.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K250489 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250489: FP3D.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K250489
Report an extraction error
Are you the manufacturer?
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