510(k) · Cleared
ClearedApex Flex
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 Apr 29, 2025 as substantially equivalent to K072402 (Cmp Industries, LLC, 2007) and 1 other predicate after a 60-day review. Its family tree reaches back 1 generation to 2006. 3 later devices descend from it.
- Decided
- Apr 29, 2025
- Review
- 60 days
- Class
- Class II
- Product code
- EBI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K053060 (2006). 2 ancestors in all. 3 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK053060 TCS UnbreakableThermoplastic Comfort Systems, Inc. · 2006
- This deviceK250617 Apex FlexSprintray, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK261626 UltraPrint Flexible Denture UVGuangzhou Heygears IMC., Inc. · 2026
- Descendant · cites it directly · 0 of its ownK261474 DENTCA Tru FlexibleDentca, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK253365 LuxCreo Flexible Partial Denture ResinLuxCreo, Inc. · 2025
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K053060 | TCS Unbreakable | Thermoplastic Comfort Systems, Inc. | 2006 | — |
| 0 (this device) | K250617 | Apex Flex | Sprintray, Inc. | 2025 | — |
| +1 | K261626 | UltraPrint Flexible Denture UV | Guangzhou Heygears IMC., Inc. | 2026 | — |
| +1 | K261474 | DENTCA Tru Flexible | Dentca, Inc. | 2026 | — |
| +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 |
| 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 K250489 FP3Dscore 14.2 · 7 generations · 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 |
|---|---|---|---|
| * | K072402 | Flex-Star VSummary page 5…ning, Repairing, Rebasing Common Name: Resin, Denture, Relining, Repairing, Rebasing Regulatory Class: Class II Product Code: EBI Primary Predicate Device: iFlex-Star V (K072402) Secondary Predicate Device: TCS® Unbreakable (K053060) Reference Device: Night Guard Flex (K212448) Device Description… | 2007 |
| * | K053060 | TCS UnbreakableSummary page 5…Relining, Repairing, Rebasing Regulatory Class: Class II Product Code: EBI Primary Predicate Device: iFlex-Star V (K072402) Secondary Predicate Device: TCS® Unbreakable (K053060) Reference Device: Night Guard Flex (K212448) Device Description SprintRay Apex Flex is a photo-polymeric methacrylate/a… | 2006 |
| † | K212448 | NightGuard Flex | 2021 |
What descends from it? (3)
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. 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?
SprintRay Apex Flex is an alternative to traditional thermoplastic material used for the fabrication and repair of partial dentures. It is intended exclusively for professional dental work.
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/K250617 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250617: Apex Flex.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K250617
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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