510(k) · Cleared
ClearedTransbond Supreme Adhesive
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
3M Unitek · DYH Adhesive, Bracket And Tooth Conditioner, Resin
Cleared on Feb 15, 2008 after a 46-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 7 later devices descend from it.
- Decided
- Feb 15, 2008
- Review
- 46 days
- Class
- Class II
- Product code
- DYH
- Recalls
- None
- Predicates
- 0
7 later devices descend from it, 3 citing it directly.
- This deviceK073697 Transbond Supreme Adhesive3M Unitek · 2008
- Descendant · cites it directly · 5 of its ownK083051 Flowtain & Flowtain LVReliance Orthodontic Products, Inc. · 2009
- Descendant · 2 generations on · 0 of its ownK234043 3M™ Transbond™ Orthodontic Adhesive3M Unitek Orthodontic Products · 2023
- Descendant · cites it directly · 0 of its ownK142881 DMRC Dual Cure Orthodontic Band CementDanville Materials, LLC · 2015
- Descendant · 2 generations on · 0 of its ownK130237 Pontic PaintReliance Orthodontic Products, Inc. · 2013
- Descendant · 2 generations on · 0 of its ownK123348 Clear Aligner AdhesiveReliance Orthodontic Products, Inc. · 2013
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K083051Flowtain & Flowtain LVReliance Orthodontic Products, Inc. · 2009 · cites it directly5descendants
- K2340433M™ Transbond™ Orthodontic Adhesive3M Unitek Orthodontic Products · 2023 · 2 generations on0descendants
- K142881DMRC Dual Cure Orthodontic Band CementDanville Materials, LLC · 2015 · cites it directly0descendants
- K130237Pontic PaintReliance Orthodontic Products, Inc. · 2013 · 2 generations on0descendants
- K123348Clear Aligner AdhesiveReliance Orthodontic Products, Inc. · 2013 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K073697 | Transbond Supreme Adhesive | 3M Unitek | 2008 | — |
| +1 | K083051 | Flowtain & Flowtain LV | Reliance Orthodontic Products, Inc. | 2009 | — |
| +2 | K234043 | 3M™ Transbond™ Orthodontic Adhesive | 3M Unitek Orthodontic Products | 2023 | — |
| +1 | K142881 | DMRC Dual Cure Orthodontic Band Cement | Danville Materials, LLC | 2015 | — |
| +2 | K130237 | Pontic Paint | Reliance Orthodontic Products, Inc. | 2013 | — |
| +2 | K123348 | Clear Aligner Adhesive | Reliance Orthodontic Products, Inc. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2013 | 2 | 0 |
| 2015 | 1 | 0 |
| 2023 | 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 DYH? 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 DYH device
- #1 K261840 BracePaste Prime Plusscore 13.8 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (7)
3 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, K083051 (Reliance Orthodontic Products, Inc., 2009) has gone furthest, with 5 descendants of its own.
How does its category compare?
All DYH devicesDYH Adhesive, Bracket And Tooth Conditioner, Resin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · DYH
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DYH
143in 2020
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DYH
1in 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DYH
1in 2025
MAUDE reports naming product code DYH, 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 | 3 | 62 | 1 | 2 |
| 2008 | 6 | 72 | 0 | 1 |
| 2009 | 3 | 77 | 0 | 1 |
| 2010 | 4 | 96 | 0 | 5 |
| 2011 | 2 | — | 0 | 1 |
| 2012 | 3 | 82 | 0 | 3 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 2 |
| 2015 | 5 | 135 | 0 | 2 |
| 2016 | 2 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 5 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 3 | 143 | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 2 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 1 |
| 2026 | 3 | 87 | 0 | — |
https://510kreport.com/device/K073697 · printed Nov 6, 2026
Cite this page
510(k) Report. “K073697: Transbond Supreme Adhesive.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K073697
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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