510(k) · Cleared
ClearedSprintRay High Impact Denture Base
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 Nov 10, 2022 as substantially equivalent to K162044 (Dentca, Inc., 2017) after a 154-day review. Its family tree reaches back 1 generation to 2017. 5 later devices descend from it.
- Decided
- Nov 10, 2022
- Review
- 154 days
- Class
- Class II
- Product code
- EBI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K162044 (2017). 5 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK162044 Dentca Denture Base IIDentca, Inc. · 2017
- This deviceK221678 SprintRay High Impact Denture BaseSprintray, Inc. · 2022
- Descendant · cites it directly · 2 of its ownK230445 OnX ToughSprintray, Inc. · 2023
- Descendant · 2 generations on · 1 of its ownK240688 RODIN Titan 3D ResinBelport Company, Inc., Gingi-Pak · 2024
- Descendant · 2 generations on · 0 of its ownK262681 NanoCeram Resin3BFAB Teknoloji a.S. · 2026
- Descendant · cites it directly · 0 of its ownK260376 Denture BaseShandong Huge Dental Material Corporation · 2026
- Descendant · cites it directly · 0 of its ownK243103 Denture BaseRiton 3D Technology Co., Ltd. · 2024
Most influential descendants
Showing 5 of 5 · See all- K230445OnX ToughSprintray, Inc. · 2023 · cites it directly2descendants
- K240688RODIN Titan 3D ResinBelport Company, Inc., Gingi-Pak · 2024 · 2 generations on1descendant
- K262681NanoCeram Resin3BFAB Teknoloji a.S. · 2026 · 2 generations on0descendants
- K260376Denture BaseShandong Huge Dental Material Corporation · 2026 · cites it directly0descendants
- K243103Denture BaseRiton 3D Technology Co., Ltd. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K162044 | Dentca Denture Base II | Dentca, Inc. | 2017 | — |
| 0 (this device) | K221678 | SprintRay High Impact Denture Base | Sprintray, Inc. | 2022 | — |
| +1 | K230445 | OnX Tough | Sprintray, Inc. | 2023 | — |
| +2 | K240688 | RODIN Titan 3D Resin | Belport Company, Inc., Gingi-Pak | 2024 | — |
| +2 | K262681 | NanoCeram Resin | 3BFAB Teknoloji a.S. | 2026 | — |
| +1 | K260376 | Denture Base | Shandong Huge Dental Material Corporation | 2026 | — |
| +1 | K243103 | Denture Base | Riton 3D Technology Co., Ltd. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2026 | 2 | 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 |
|---|---|---|---|
| * | K162044 | Dentca Denture Base IISummary page 4…ining, repairing, or rebasing resin Regulatory Class: Class II Regulation Number: 21 CFR 872.3760 Product Code: EBI Primary Predicate Device: Dentca Denture Base II (K162044) Reference Devices: Dentca Denture Base (K143033) Device Description Fabrication of dental prosthetics with High Impact… | 2017 |
| † | K143033 | Dentca Denture Base | 2015 |
What descends from it? (5)
3 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?
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. 2022, 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?
The SprintRay High Impact Denture Base resin is a light-curable polymerizable resin intended to be
used for the fabrication and repair, of full and partial removable dentures and baseplates. The
material is an alternative to traditional denture base material.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K221678 · printed Nov 6, 2026
Cite this page
510(k) Report. “K221678: SprintRay High Impact Denture Base.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K221678
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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