510(k) · Cleared
ClearedTrubyte Denture Base Resin 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 Jul 12, 2001 after a 52-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 37 later devices descend from it.
- Decided
- Jul 12, 2001
- Review
- 52 days
- Class
- Class II
- Product code
- EBI
- Recalls
- None
- Predicates
- 0
37 later devices descend from it, 3 citing it directly.
- This deviceK011560 Trubyte Denture Base Resin SystemDentsply Intl. · 2001
- Descendant · cites it directly · 35 of its ownK032892 Modification to Trubyte Denture Base Resin SystemDentsply Intl. · 2003
- Descendant · 2 generations on · 30 of its ownK143033 Dentca Denture BaseDentca, Inc. · 2015
- Descendant · 3 generations on · 28 of its ownK162572 NextDent Denture, E-DentureVertex-Dental B.V. · 2017
- Descendant · 4 generations on · 13 of its ownK191497 NextDent Denture 3D+Vertex-Dental B.V. · 2019
- Descendant · 4 generations on · 7 of its ownK190043 Halley resinDentsply Sirona · 2019
Showing 5 of 37 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 37 · See all- K032892Modification to Trubyte Denture Base Resin SystemDentsply Intl. · 2003 · cites it directly35descendants
- K143033Dentca Denture BaseDentca, Inc. · 2015 · 2 generations on30descendants
- K162572NextDent Denture, E-DentureVertex-Dental B.V. · 2017 · 3 generations on28descendants
- K191497NextDent Denture 3D+Vertex-Dental B.V. · 2019 · 4 generations on13descendants
- K190043Halley resinDentsply Sirona · 2019 · 4 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K011560 | Trubyte Denture Base Resin System | Dentsply Intl. | 2001 | — |
| +1 | K032892 | Modification to Trubyte Denture Base Resin System | Dentsply Intl. | 2003 | — |
| +2 | K143033 | Dentca Denture Base | Dentca, Inc. | 2015 | — |
| +3 | K162572 | NextDent Denture, E-Denture | Vertex-Dental B.V. | 2017 | — |
| +4 | K191497 | NextDent Denture 3D+ | Vertex-Dental B.V. | 2019 | — |
| +4 | K190043 | Halley resin | Dentsply Sirona | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 3 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 3 | 0 |
| 2023 | 4 | 0 |
| 2024 | 5 | 0 |
| 2025 | 6 | 0 |
| 2026 | 4 | 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? (37)
See all 373 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, K032892 (Dentsply Intl., 2003) has gone furthest, with 35 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/K011560 · printed Nov 6, 2026
Cite this page
510(k) Report. “K011560: Trubyte Denture Base Resin System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K011560
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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