510(k) · Cleared
ClearedOnX Tough
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sprintray, Inc. · EBI Resin, Denture, Relining, Repairing, Rebasing
Cleared on Jul 14, 2023 as substantially equivalent to K221678 (Sprintray, Inc., 2022) and 1 other predicate after a 143-day review. Its family tree reaches back 6 generations to 1990. 2 later devices descend from it.
- Decided
- Jul 14, 2023
- Review
- 143 days
- Class
- Class II
- Product code
- EBI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K901789 (1990). 17 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK901789 Paladon (R) 65Kulzer, Inc. · 1990
- 5 generations backK081884 Major.Base 20Major Prodotti Dentari S.P.A. · 2008
- 4 generations backK102654 Vertex Rapid SimplifiedVertex-Dental B.V. · 2010
- 3 generations backK130076 Promolux, Promolux HI, Weropress, Premeco PCSMerz Dental GmbH · 2013
- 2 generations backK140758 M-PM-Disc (Pink)Merz Dental GmbH · 2014
- 1 generation backK151142 Ivobase Cad for Zenotec, Ivobase Cad Bond, Ivobase Cad Modelling…Wieland Dental + Technik GmbH & Co. KG · 2015
- This deviceK230445 OnX ToughSprintray, Inc. · 2023
- Descendant · cites it directly · 1 of its ownK240688 RODIN Titan 3D ResinBelport Company, Inc., Gingi-Pak · 2024
- Descendant · cites it directly · 0 of its ownK262681 NanoCeram Resin3BFAB Teknoloji a.S. · 2026
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K901789 | Paladon (R) 65 | Kulzer, Inc. | 1990 | — |
| −5 | K081884 | Major.Base 20 | Major Prodotti Dentari S.P.A. | 2008 | — |
| −4 | K102654 | Vertex Rapid Simplified | Vertex-Dental B.V. | 2010 | — |
| −3 | K130076 | Promolux, Promolux HI, Weropress, Premeco PCS | Merz Dental GmbH | 2013 | — |
| −2 | K140758 | M-PM-Disc (Pink) | Merz Dental GmbH | 2014 | — |
| −1 | K151142 | Ivobase Cad for Zenotec, Ivobase Cad Bond, Ivobase Cad Modelling Liquid | Wieland Dental + Technik GmbH & Co. KG | 2015 | — |
| 0 (this device) | K230445 | OnX Tough | Sprintray, Inc. | 2023 | — |
| +1 | K240688 | RODIN Titan 3D Resin | Belport Company, Inc., Gingi-Pak | 2024 | — |
| +1 | K262681 | NanoCeram Resin | 3BFAB Teknoloji a.S. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2011 | 2 | 0 |
| 2017 | 1 | 0 |
| 2022 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K221678 | SprintRay High Impact Denture BaseSummary page 4…PZY Device Class II II 510(k)-Exempt Primary Predicate K221678, SprintRay High Impact Denture Base, (EBI product code) Secondary Predicate K151142, Iv… | 2022 |
| * | K151142 | Ivobase Cad for Zenotec, Ivobase Cad Bond, Ivobase Cad Modelling LiquidSummary page 4…10(k)-Exempt Primary Predicate K221678, SprintRay High Impact Denture Base, (EBI product code) Secondary Predicate K151142, IvoBase CAD for Zenotec, (EBI product code) Device Description OnX Tough resin consists o… | 2015 |
What descends from it? (2)
2 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 33 years and passes through 6 companies; a new generation was cleared every 2.7 years on median.
- None of the 17 ancestors has a recall.
- Of its descendants, K240688 (Belport Company, Inc., Gingi-Pak, 2024) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K221678.
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?
SprintRay OnX Tough is a tooth shade ceramic-hybrid resin used for the fabrication of hybrid denture prosthetics, implant-supported denture prosthetics, monolithic full and partial removable dentures, and preformed denture teeth to be used in a denture.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K230445 · printed Nov 6, 2026
Cite this page
510(k) Report. “K230445: OnX Tough.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K230445
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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