510(k) · Cleared
ClearedLuxCreo Flexible Partial Denture Resin
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
LuxCreo, Inc. · EBI Resin, Denture, Relining, Repairing, Rebasing
Cleared on Nov 25, 2025 as substantially equivalent to K250617 (Sprintray, Inc., 2025) and 1 other predicate after a 56-day review. Its family tree reaches back 8 generations to 2001.
- Decided
- Nov 25, 2025
- Review
- 56 days
- Class
- Class II
- Product code
- EBI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K011560 (2001). 12 ancestors in all. No later device cites it as a predicate yet.
- Root · 8 generations backK011560 Trubyte Denture Base Resin SystemDentsply Intl. · 2001
- 7 generations backK032892 Modification to Trubyte Denture Base Resin SystemDentsply Intl. · 2003
- 6 generations backK143033 Dentca Denture BaseDentca, Inc. · 2015
- 5 generations backK162572 NextDent Denture, E-DentureVertex-Dental B.V. · 2017
- 4 generations backK191497 NextDent Denture 3D+Vertex-Dental B.V. · 2019
- 3 generations backK203641 E-Denture ProEnvisiontec GmbH · 2021
- 2 generations backK241089 KeyPrint KeyDenture BaseKeystone Industries · 2024
- 1 generation backK250489 FP3DKeystone Industries · 2025
- This deviceK253365 LuxCreo Flexible Partial Denture ResinLuxCreo, Inc. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K011560 | Trubyte Denture Base Resin System | Dentsply Intl. | 2001 | — |
| −7 | K032892 | Modification to Trubyte Denture Base Resin System | Dentsply Intl. | 2003 | — |
| −6 | K143033 | Dentca Denture Base | Dentca, Inc. | 2015 | — |
| −5 | K162572 | NextDent Denture, E-Denture | Vertex-Dental B.V. | 2017 | — |
| −4 | K191497 | NextDent Denture 3D+ | Vertex-Dental B.V. | 2019 | — |
| −3 | K203641 | E-Denture Pro | Envisiontec GmbH | 2021 | — |
| −2 | K241089 | KeyPrint KeyDenture Base | Keystone Industries | 2024 | — |
| −1 | K250489 | FP3D | Keystone Industries | 2025 | — |
| 0 (this device) | K253365 | LuxCreo Flexible Partial Denture Resin | LuxCreo, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K250617 | Apex FlexSummary page 8…ation Description: Denture relining, repairing, or rebasing resin. Regulation Number: 21 CFR 872.3760 Device Class: Class II Product Code: EBI 510(k) Number: K250617 510(k) Submitter: SprintRay Inc. Review Panel: Dental 7.2 Secondary Predicate Device: Primary Predicate Device Name:… | 2025 |
| * | K250489 | FP3DSummary page 8…ation Description: Denture relining, repairing, or rebasing resin. Regulation Number: 21 CFR 872.3760 Device Class: Class II Product Code: EBI 510(k) Number: K250489 510(k) Submitter: Keystone Industries Review Panel: Dental 7.3 Reference Device: Reference Device Name: LuxCreo Clear… | 2025 |
| † | K250343 | LuxCreo Clear Aligner System | 2025 |
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 24 years and passes through 6 companies; a new generation was cleared every 2.2 years on median.
- None of the 12 ancestors has a recall.
- 2 other devices also cite its predicate K250617.
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?
LuxCreo Flexible Partial Denture Resin is a liquid light-curing resin indicated for the fabrication and repair of partial denture bases. It is intended for use by dental professionals in dental and orthodontic laboratories and clinics. LuxCreo Flexible Partial Denture Resin is intended for the additive manufacturing of removable partial denture bases, including denture bases for interim and transitional dentures, for the replacement of one or more…
Read the full statement (104 words)
LuxCreo Flexible Partial Denture Resin is a liquid light-curing resin indicated for the fabrication and repair of partial denture bases. It is intended for use by dental professionals in dental and orthodontic laboratories and clinics.
LuxCreo Flexible Partial Denture Resin is intended for the additive manufacturing of removable partial denture bases, including denture bases for interim and transitional dentures, for the replacement of one or more missing teeth. The device is supported by remaining natural dentition and oral tissues. Partial dentures manufactured using this resin may be used permanently as a total removable replacement or temporarily while the patient is preparing for permanent implant.
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/K253365 · printed Nov 6, 2026
Cite this page
510(k) Report. “K253365: LuxCreo Flexible Partial Denture Resin.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K253365
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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