510(k) · Cleared
ClearedFlex-Star V
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cmp Industries, LLC · EBI Resin, Denture, Relining, Repairing, Rebasing
Cleared on Oct 19, 2007 after a 53-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 5 later devices descend from it.
- Decided
- Oct 19, 2007
- Review
- 53 days
- Class
- Class II
- Product code
- EBI
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 2 citing it directly.
- This deviceK072402 Flex-Star VCmp Industries, LLC · 2007
- Descendant · cites it directly · 3 of its ownK250617 Apex FlexSprintray, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK261626 UltraPrint Flexible Denture UVGuangzhou Heygears IMC., Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK261474 DENTCA Tru FlexibleDentca, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK253365 LuxCreo Flexible Partial Denture ResinLuxCreo, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK170375 Nobilplast Denture ResinCmp Industries, LLC · 2017
Most influential descendants
Showing 5 of 5 · See all- K250617Apex FlexSprintray, Inc. · 2025 · cites it directly3descendants
- K261626UltraPrint Flexible Denture UVGuangzhou Heygears IMC., Inc. · 2026 · 2 generations on0descendants
- K261474DENTCA Tru FlexibleDentca, Inc. · 2026 · 2 generations on0descendants
- K253365LuxCreo Flexible Partial Denture ResinLuxCreo, Inc. · 2025 · 2 generations on0descendants
- K170375Nobilplast Denture ResinCmp Industries, LLC · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K072402 | Flex-Star V | Cmp Industries, LLC | 2007 | — |
| +1 | K250617 | Apex Flex | Sprintray, Inc. | 2025 | — |
| +2 | K261626 | UltraPrint Flexible Denture UV | Guangzhou Heygears IMC., Inc. | 2026 | — |
| +2 | K261474 | DENTCA Tru Flexible | Dentca, Inc. | 2026 | — |
| +2 | K253365 | LuxCreo Flexible Partial Denture Resin | LuxCreo, Inc. | 2025 | — |
| +1 | K170375 | Nobilplast Denture Resin | Cmp Industries, LLC | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (5)
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?
- Of its descendants, K250617 (Sprintray, Inc., 2025) has gone furthest, with 3 descendants of its own.
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. 2007, 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?
CMP's Flex-Star V is used for the fabrication of partial or full removable dentures, as well as occusal splints and night guards. It is to be used only by professional dental practitioners who make or repair dentures for patients
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K072402 · printed Nov 6, 2026
Cite this page
510(k) Report. “K072402: Flex-Star V.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K072402
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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