510(k) · Cleared
ClearedModification to Trubyte 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 Sep 26, 2003 as substantially equivalent to K011560 (Dentsply Intl., 2001) after a 9-day review. Its family tree reaches back 1 generation to 2001. 35 later devices descend from it.
- Decided
- Sep 26, 2003
- Review
- 9 days
- Class
- Class II
- Product code
- EBI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K011560 (2001). 35 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK011560 Trubyte Denture Base Resin SystemDentsply Intl. · 2001
- This deviceK032892 Modification to Trubyte Denture Base Resin SystemDentsply Intl. · 2003
- Descendant · cites it directly · 30 of its ownK143033 Dentca Denture BaseDentca, Inc. · 2015
- Descendant · 2 generations on · 28 of its ownK162572 NextDent Denture, E-DentureVertex-Dental B.V. · 2017
- Descendant · 3 generations on · 13 of its ownK191497 NextDent Denture 3D+Vertex-Dental B.V. · 2019
- Descendant · 3 generations on · 7 of its ownK190043 Halley resinDentsply Sirona · 2019
- Descendant · 4 generations on · 3 of its ownK210298 GR-14 Resin SystemPro3Dure Medical GmbH · 2021
Showing 5 of 35 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 35 · See all- K143033Dentca Denture BaseDentca, Inc. · 2015 · cites it directly30descendants
- K162572NextDent Denture, E-DentureVertex-Dental B.V. · 2017 · 2 generations on28descendants
- K191497NextDent Denture 3D+Vertex-Dental B.V. · 2019 · 3 generations on13descendants
- K190043Halley resinDentsply Sirona · 2019 · 3 generations on7descendants
- K210298GR-14 Resin SystemPro3Dure Medical GmbH · 2021 · 4 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K011560 | Trubyte Denture Base Resin System | Dentsply Intl. | 2001 | — |
| 0 (this device) | K032892 | Modification to Trubyte Denture Base Resin System | Dentsply Intl. | 2003 | — |
| +1 | K143033 | Dentca Denture Base | Dentca, Inc. | 2015 | — |
| +2 | K162572 | NextDent Denture, E-Denture | Vertex-Dental B.V. | 2017 | — |
| +3 | K191497 | NextDent Denture 3D+ | Vertex-Dental B.V. | 2019 | — |
| +3 | K190043 | Halley resin | Dentsply Sirona | 2019 | — |
| +4 | K210298 | GR-14 Resin System | Pro3Dure Medical GmbH | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 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), 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 |
|---|---|---|---|
| * | K011560 | Trubyte Denture Base Resin System | 2001 |
What descends from it? (35)
See all 353 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?
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 TrubyteO Denture Base Resin System is indicated for:
1. Fabrication of dentures. appliances and prostheses
2. Repair of dentures. appliances and prostheses
3. Relining of denture surfaces
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032892 · printed Nov 6, 2026
Cite this page
510(k) Report. “K032892: Modification to 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/K032892
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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