510(k) · Cleared
ClearedTransbond Light Cured Orthodontic Adhesive
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Unitek Corp. · DYH Adhesive, Bracket And Tooth Conditioner, Resin
Cleared on Mar 31, 1988 after a 62-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 8 later devices descend from it.
- Decided
- Mar 31, 1988
- Review
- 62 days
- Class
- Class II
- Product code
- DYH
- Recalls
- None
- Predicates
- 0
8 later devices descend from it, 6 citing it directly.
- This deviceK880393 Transbond Light Cured Orthodontic AdhesiveUnitek Corp. · 1988
- Descendant · cites it directly · 1 of its ownK192682 Orthocem, Ortho BiteDentscare Ltda · 2020
- Descendant · cites it directly · 1 of its ownK160782 BracePaste AdhesiveAmerican Orthodontics · 2016
- Descendant · cites it directly · 0 of its ownK250015 Ormco™ EtchFree Bonding System, Ormco™ EtchFree Bonding Primer…Ormco Corporation · 2025
- Descendant · 2 generations on · 0 of its ownK214054 TP Orthodontics Light-Cure Adhesive System, TP Orthodontics…Tp Orthodontics, Inc. · 2022
- Descendant · cites it directly · 0 of its ownK210115 FiteBac CC OrthoSealLargent Health, LLC · 2021
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K192682Orthocem, Ortho BiteDentscare Ltda · 2020 · cites it directly1descendant
- K160782BracePaste AdhesiveAmerican Orthodontics · 2016 · cites it directly1descendant
- K250015Ormco™ EtchFree Bonding System, Ormco™ EtchFree Bonding Primer, Ormco™ EtchFree AdhesiveOrmco Corporation · 2025 · cites it directly0descendants
- K214054TP Orthodontics Light-Cure Adhesive System, TP Orthodontics Pre-Applied Adhesive, TP…Tp Orthodontics, Inc. · 2022 · 2 generations on0descendants
- K210115FiteBac CC OrthoSealLargent Health, LLC · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K880393 | Transbond Light Cured Orthodontic Adhesive | Unitek Corp. | 1988 | — |
| +1 | K192682 | Orthocem, Ortho Bite | Dentscare Ltda | 2020 | — |
| +1 | K160782 | BracePaste Adhesive | American Orthodontics | 2016 | — |
| +1 | K250015 | Ormco™ EtchFree Bonding System, Ormco™ EtchFree Bonding Primer, Ormco™… | Ormco Corporation | 2025 | — |
| +2 | K214054 | TP Orthodontics Light-Cure Adhesive System, TP Orthodontics Pre-Applied… | Tp Orthodontics, Inc. | 2022 | — |
| +1 | K210115 | FiteBac CC OrthoSeal | Largent Health, LLC | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 2 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2025 | 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 13.9 · 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 has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (8)
6 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K192682 | Orthocem, Ortho Bite | 2020 | 1 |
| K160782 | BracePaste Adhesive | 2016 | 1 |
| K250015 | Ormco™ EtchFree Bonding System, Ormco™ EtchFree Bonding Primer, Ormco™ EtchFree Adhesive | 2025 | 0 |
| K210115 | FiteBac CC OrthoSeal | 2021 | 0 |
| K173020 | OBA-MCP, Orthodontic Bracket Adhesive with MCP | 2018 | 0 |
| K161684 | Quantum LB | 2016 | 0 |
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, K192682 (Dentscare Ltda, 2020) has gone furthest, with 1 descendant 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.
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/K880393 · printed Nov 4, 2026
Cite this page
510(k) Report. “K880393: Transbond Light Cured Orthodontic Adhesive.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K880393
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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