510(k) · Cleared
ClearedDuraflex
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cosmetic Dental Materials, Inc. · EBI Resin, Denture, Relining, Repairing, Rebasing
Cleared on Feb 8, 2007 after a 64-day review. The FDA summary names its predicate without a number. 5 later devices descend from it.
- Decided
- Feb 8, 2007
- Review
- 64 days
- Class
- Class II
- Product code
- EBI
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 4 citing it directly.
- This deviceK063626 DuraflexCosmetic Dental Materials, Inc. · 2007
- Descendant · cites it directly · 1 of its ownK250489 FP3DKeystone Industries · 2025
- Descendant · 2 generations on · 0 of its ownK253365 LuxCreo Flexible Partial Denture ResinLuxCreo, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK172407 DuracetalThe Myerson Company Limited · 2017
- Descendant · cites it directly · 0 of its ownK123396 I.Flex by TCSThermoplastic Comfort Systems, Inc. · 2013
- Descendant · cites it directly · 0 of its ownK111709 Foundation Dental ResinUnix-Japan Co., Ltd. · 2011
Most influential descendants
Showing 5 of 5 · See all- K250489FP3DKeystone Industries · 2025 · cites it directly1descendant
- K253365LuxCreo Flexible Partial Denture ResinLuxCreo, Inc. · 2025 · 2 generations on0descendants
- K172407DuracetalThe Myerson Company Limited · 2017 · cites it directly0descendants
- K123396I.Flex by TCSThermoplastic Comfort Systems, Inc. · 2013 · cites it directly0descendants
- K111709Foundation Dental ResinUnix-Japan Co., Ltd. · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K063626 | Duraflex | Cosmetic Dental Materials, Inc. | 2007 | — |
| +1 | K250489 | FP3D | Keystone Industries | 2025 | — |
| +2 | K253365 | LuxCreo Flexible Partial Denture Resin | LuxCreo, Inc. | 2025 | — |
| +1 | K172407 | Duracetal | The Myerson Company Limited | 2017 | — |
| +1 | K123396 | I.Flex by TCS | Thermoplastic Comfort Systems, Inc. | 2013 | — |
| +1 | K111709 | Foundation Dental Resin | Unix-Japan Co., Ltd. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2017 | 1 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | — | Lucitone FRS Flexible Dental Resin Named without a submission number |
What descends from it? (5)
4 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, K250489 (Keystone Industries, 2025) has gone furthest, with 1 descendant 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?
The DuraFlex thermoplastic resin is used for the fabrication of partial or full removable dentures, as well as occlusal splints and night guards.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063626 · printed Nov 5, 2026
Cite this page
510(k) Report. “K063626: Duraflex.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K063626
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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