510(k) · Cleared
ClearedTrubyte Denture Bond Denture Bonding Agent
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dentsply Intl. · KLE Agent, Tooth Bonding, Resin
Cleared on Jul 22, 1998 as substantially equivalent to K924422 (Heraeus Kulzer, Inc., 1992) after a 44-day review. Its family tree reaches back 1 generation to 1992. 5 later devices descend from it.
- Decided
- Jul 22, 1998
- Review
- 44 days
- Class
- Class II
- Product code
- KLE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K924422 (1992). 5 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK924422 PalabondHeraeus Kulzer, Inc. · 1992
- This deviceK982007 Trubyte Denture Bond Denture Bonding AgentDentsply Intl. · 1998
- Descendant · cites it directly · 4 of its ownK051707 Eclipse Bonding AgentDentsply Intl. · 2005
- Descendant · 2 generations on · 2 of its ownK231578 Lucitone Digital Print Denture SystemDentsply Sirona · 2023
- Descendant · 3 generations on · 0 of its ownK262300 Denture Base Resin V2Formlabs Ohio, Inc. · 2026
- Descendant · 3 generations on · 0 of its ownK243336 Lucitone Digital Print Denture™ SystemDentsply Sirona, Inc. · 2024
- Descendant · 2 generations on · 0 of its ownK180917 GC Acrylic PrimerGC America, Inc. · 2018
Most influential descendants
Showing 5 of 5 · See all- K051707Eclipse Bonding AgentDentsply Intl. · 2005 · cites it directly4descendants
- K231578Lucitone Digital Print Denture SystemDentsply Sirona · 2023 · 2 generations on2descendants
- K262300Denture Base Resin V2Formlabs Ohio, Inc. · 2026 · 3 generations on0descendants
- K243336Lucitone Digital Print Denture™ SystemDentsply Sirona, Inc. · 2024 · 3 generations on0descendants
- K180917GC Acrylic PrimerGC America, Inc. · 2018 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K924422 | Palabond | Heraeus Kulzer, Inc. | 1992 | — |
| 0 (this device) | K982007 | Trubyte Denture Bond Denture Bonding Agent | Dentsply Intl. | 1998 | — |
| +1 | K051707 | Eclipse Bonding Agent | Dentsply Intl. | 2005 | — |
| +2 | K231578 | Lucitone Digital Print Denture System | Dentsply Sirona | 2023 | — |
| +3 | K262300 | Denture Base Resin V2 | Formlabs Ohio, Inc. | 2026 | — |
| +3 | K243336 | Lucitone Digital Print Denture™ System | Dentsply Sirona, Inc. | 2024 | — |
| +2 | K180917 | GC Acrylic Primer | GC America, Inc. | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2018 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2026 | 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 KLE? 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 KLE device
- #1 K262252 MPa Max adhesivescore 15.1 · 11 generations · 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 |
|---|---|---|---|
| * | K924422 | PalabondSummary page 1…ADE OR PROPRIETARY NAME: TRUBYTE® DENTURE BOND Denture Bonding Agent CLASSIFICATION NAME: Resin tooth bonding agent 872.3200 PREDICATE DEVICES: Palabond® Adhesion Primer K924422 DEVICE DESCRIPTION: TRUBYTE® DENTURE BOND Denture Bonding Agent is a polymer/ monomer liquid solution. It is compatible with bot… | 1992 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K051707 | Eclipse Bonding Agent | 2005 | 4 |
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?
- Its one ancestor has no recall.
- Of its descendants, K051707 (Dentsply Intl., 2005) has gone furthest, with 4 descendants of its own.
How does its category compare?
All KLE devicesKLE Agent, Tooth Bonding, Resin: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KLE
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KLE
149in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KLE
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KLE
3in 2025
MAUDE reports naming product code KLE, 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 | 14 | 71 | 2 | 18 |
| 2008 | 3 | 66 | 0 | 9 |
| 2009 | 7 | 79 | 1 | 11 |
| 2010 | 8 | 93 | 1 | 13 |
| 2011 | 10 | 100 | 0 | 69 |
| 2012 | 5 | 66 | 0 | 176 |
| 2013 | 11 | 115 | 0 | 248 |
| 2014 | 6 | 120 | 0 | 260 |
| 2015 | 10 | 118 | 0 | 100 |
| 2016 | 3 | 148 | 1 | 47 |
| 2017 | 4 | 171 | 1 | 42 |
| 2018 | 8 | 124 | 0 | 31 |
| 2019 | 6 | 143 | 0 | 20 |
| 2020 | 6 | 195 | 0 | 6 |
| 2021 | 4 | 163 | 0 | 6 |
| 2022 | 8 | 98 | 0 | 7 |
| 2023 | 6 | 75 | 0 | 7 |
| 2024 | 7 | 61 | 1 | 12 |
| 2025 | 3 | 149 | 0 | 3 |
| 2026 | 7 | 84 | 0 | — |
What is it indicated for?
TRUBYTE® DENTURE BOND Denture Bonding Agent is used to bond plastic denture teeth and denture reline materials to acrylic denture bases.
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/K982007 · printed Nov 4, 2026
Cite this page
510(k) Report. “K982007: Trubyte Denture Bond Denture Bonding Agent.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K982007
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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