510(k) · Cleared
ClearedSprintRay 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 Sep 14, 2022 as substantially equivalent to K143033 (Dentca, Inc., 2015) after a 163-day review. Its family tree reaches back 3 generations to 2001. 1 later device descends from it.
- Decided
- Sep 14, 2022
- Review
- 163 days
- Class
- Class II
- Product code
- EBI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K011560 (2001). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK011560 Trubyte Denture Base Resin SystemDentsply Intl. · 2001
- 2 generations backK032892 Modification to Trubyte Denture Base Resin SystemDentsply Intl. · 2003
- 1 generation backK143033 Dentca Denture BaseDentca, Inc. · 2015
- This deviceK220979 SprintRay Denture BaseSprintray, Inc. · 2022
- Descendant · cites it directly · 0 of its ownK260569 DB 4000 High Impact Denture BaseCarbon, Inc. · 2026
Most influential descendants
Showing 1 of 1 · See all- K260569DB 4000 High Impact Denture BaseCarbon, Inc. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K011560 | Trubyte Denture Base Resin System | Dentsply Intl. | 2001 | — |
| −2 | K032892 | Modification to Trubyte Denture Base Resin System | Dentsply Intl. | 2003 | — |
| −1 | K143033 | Dentca Denture Base | Dentca, Inc. | 2015 | — |
| 0 (this device) | K220979 | SprintRay Denture Base | Sprintray, Inc. | 2022 | — |
| +1 | K260569 | DB 4000 High Impact Denture Base | Carbon, Inc. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K143033 | Dentca Denture BaseSummary page 4…cation Name: Denture Base, Prescription Regulatory Class: Class II Regulation Number: 21 CFR 872.3760 Product Code: EBI Predicate Devices Dentca Denture Base (K143033) Device Description SprintRay Denture Base consists of a curable dental acrylate resin that is designed to be used… | 2015 |
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 |
|---|---|---|---|
| K260569 | DB 4000 High Impact Denture Base | 2026 | 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 21 years and passes through 3 companies; a new generation was cleared every 7.2 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K260569 (Carbon, Inc., 2026) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K143033.
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?
SprintRay 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.
Fabrication of dental prosthetics with SprintRay Denture Base resin requires computer-aided design and manufacturing system that includes the following components not part of the device: oral casting impression, digital denture base file created in an optical impression system, 3D printer, and curing light equipment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K220979 · printed Nov 4, 2026
Cite this page
510(k) Report. “K220979: SprintRay Denture Base.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K220979
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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