510(k) · Cleared
ClearedMyerson's Permasoft Soft Reline Material
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Austenal, Inc. · EBI Resin, Denture, Relining, Repairing, Rebasing
Cleared on Jan 5, 1994 after a 173-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 later devices descend from it.
- Decided
- Jan 5, 1994
- Review
- 173 days
- Class
- Class II
- Product code
- EBI
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK933468 Myerson's Permasoft Soft Reline MaterialAustenal, Inc. · 1994
- Descendant · cites it directly · 2 of its ownK964040 Trubyte Soft Reline SystemDentsply Intl. · 1996
- Descendant · 2 generations on · 0 of its ownK140146 Comfortsoft Soft Denture Liner SystemWhip Mix Corp. · 2014
- Descendant · cites it directly · 0 of its ownK081554 Tokuyama TissuecareTokuyama Dental Corporation · 2009
- Descendant · 2 generations on · 0 of its ownK983357 Mucopren Soft Relining SystemRoydent Dental Products, Inc. · 1998
Most influential descendants
Showing 4 of 4 · See all- K964040Trubyte Soft Reline SystemDentsply Intl. · 1996 · cites it directly2descendants
- K140146Comfortsoft Soft Denture Liner SystemWhip Mix Corp. · 2014 · 2 generations on0descendants
- K081554Tokuyama TissuecareTokuyama Dental Corporation · 2009 · cites it directly0descendants
- K983357Mucopren Soft Relining SystemRoydent Dental Products, Inc. · 1998 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K933468 | Myerson's Permasoft Soft Reline Material | Austenal, Inc. | 1994 | — |
| +1 | K964040 | Trubyte Soft Reline System | Dentsply Intl. | 1996 | — |
| +2 | K140146 | Comfortsoft Soft Denture Liner System | Whip Mix Corp. | 2014 | — |
| +1 | K081554 | Tokuyama Tissuecare | Tokuyama Dental Corporation | 2009 | — |
| +2 | K983357 | Mucopren Soft Relining System | Roydent Dental Products, Inc. | 1998 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 2009 | 1 | 0 |
| 2014 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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 has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (4)
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, K964040 (Dentsply Intl., 1996) has gone furthest, with 2 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.
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 | — |
https://510kreport.com/device/K933468 · printed Nov 6, 2026
Cite this page
510(k) Report. “K933468: Myerson's Permasoft Soft Reline Material.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K933468
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026