510(k) · Cleared
ClearedAegis Ortho Light-Cured Orthodontic Adhesive
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Harry J. Bosworth Co. · DYH Adhesive, Bracket And Tooth Conditioner, Resin
Cleared on Mar 19, 2004 after a 17-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Mar 19, 2004
- Review
- 17 days
- Class
- Class II
- Product code
- DYH
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), 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
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What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it?
No later submission names this one as a predicate yet.
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.
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 | — |
What is it indicated for?
The orthodontic adhesive is used to bond dental orthodontic brackets onto a tooth or teeth where a filled, light-cure (light-activated) resin-adhesive is indicated. This type of cure is used when sufficient light exposure is possible due to the low opacity of the bracket or through excessive use of adhesive the adhesive can be directly exposed to light. The orthodontic adhesive can also be used to bond orthodontic bands in place where a filled light-cure…
Read the full statement (135 words)
The orthodontic adhesive is used to bond dental orthodontic brackets onto a tooth or teeth where a filled, light-cure (light-activated) resin-adhesive is indicated. This type of cure is used when sufficient light exposure is possible due to the low opacity of the bracket or through excessive use of adhesive the adhesive can be directly exposed to light.
The orthodontic adhesive can also be used to bond orthodontic bands in place where a filled light-cure resin-adhesive is indicated (sufficient light exposure is possible to cure/harden/polymerize the adhesive).
The adhesive can also be used to bond or cement a non-opaque dental restoration (crown, bridge, veneer, inlay, only, etc.) to the tooth when the material of the restoration permits sufficient light through it to cure/harden/polymerize the adhesive. It is not indicated when radiopacity is needed in the adhesive.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K040548 · printed Nov 5, 2026
Cite this page
510(k) Report. “K040548: Aegis Ortho Light-Cured Orthodontic Adhesive.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K040548
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026