510(k) · Cleared
ClearedTrubyte Soft Reline System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dentsply Intl. · EBI Resin, Denture, Relining, Repairing, Rebasing
Cleared on Dec 6, 1996 as substantially equivalent to K901621 (Dental Product Co., 1990) and 1 other predicate after a 59-day review. Its family tree reaches back 1 generation to 1990. 2 later devices descend from it.
- Decided
- Dec 6, 1996
- Review
- 59 days
- Class
- Class II
- Product code
- EBI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K901621 (1990). 2 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK901621 New Per-Fit (R) ImprovedDental Product Co. · 1990
- This deviceK964040 Trubyte Soft Reline SystemDentsply Intl. · 1996
- Descendant · cites it directly · 0 of its ownK140146 Comfortsoft Soft Denture Liner SystemWhip Mix Corp. · 2014
- Descendant · cites it directly · 0 of its ownK983357 Mucopren Soft Relining SystemRoydent Dental Products, Inc. · 1998
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K901621 | New Per-Fit (R) Improved | Dental Product Co. | 1990 | — |
| 0 (this device) | K964040 | Trubyte Soft Reline System | Dentsply Intl. | 1996 | — |
| +1 | K140146 | Comfortsoft Soft Denture Liner System | Whip Mix Corp. | 2014 | — |
| +1 | K983357 | Mucopren Soft Relining System | Roydent Dental Products, Inc. | 1998 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2014 | 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? (3)
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 |
|---|---|---|---|
| * | K901621 | New Per-Fit (R) ImprovedSummary page 1…ptember 26, 1996 TRADE NAME: TRUBYTE® SOFT RELINE SYSTEM CLASSIFICATION NAME: Relining, repairing or rebasing denture base resin PREDICATE DEVICES: New Per-Fit Improved K901621 Molloplast B Unknown PermaSoft K933468 DEVICE DESCRIPTION: The TRUBYTE® SOFT RELINE SYSTEM consists of three components: TRUBYT… | 1990 |
| * | K933468 | Myerson's Permasoft Soft Reline MaterialSummary page 1…OFT RELINE SYSTEM CLASSIFICATION NAME: Relining, repairing or rebasing denture base resin PREDICATE DEVICES: New Per-Fit Improved K901621 Molloplast B Unknown PermaSoft K933468 DEVICE DESCRIPTION: The TRUBYTE® SOFT RELINE SYSTEM consists of three components: TRUBYTE® Soft Reline Material, TRUBYTE® Soft… | 1994 |
| * | — | Molloplast B Named without a submission number | |
| † | K926406 | Dual Cure Reline Material | 1993 |
| † | K952351 | Precise Denture Base Resin | 1995 |
What descends from it? (2)
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?
- None of the 2 ancestors has a recall.
- Of its descendants, K140146 (Whip Mix Corp., 2014) has gone furthest, with 0 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 | — |
What is it indicated for?
The TRUBYTE® SOFT RELINE SYSTEM is for use as a long-term resilient lining material for removable dentures.
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/K964040 · printed Nov 4, 2026
Cite this page
510(k) Report. “K964040: Trubyte Soft Reline System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K964040
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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