510(k) · Cleared
ClearedIdeal 1 Orthodontic Bracket Adhesive
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dentsply Intl. · DYH Adhesive, Bracket And Tooth Conditioner, Resin
Cleared on Feb 6, 2004 as substantially equivalent to K933766 (Silmet U.S.A. Corp., 1994) after a 73-day review. Its family tree reaches back 1 generation to 1994. 2 later devices descend from it.
- Decided
- Feb 6, 2004
- Review
- 73 days
- Class
- Class II
- Product code
- DYH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K933766 (1994). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK933766 High-Q-BondSilmet U.S.A. Corp. · 1994
- This deviceK033703 Ideal 1 Orthodontic Bracket AdhesiveDentsply Intl. · 2004
- Descendant · cites it directly · 0 of its ownK050750 LC Bracket Adhesive SystemDentsply Intl. · 2005
- Descendant · cites it directly · 0 of its ownK040375 Ideal 1 Orthodontic Band CementDentsply Intl. · 2004
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K933766 | High-Q-Bond | Silmet U.S.A. Corp. | 1994 | — |
| 0 (this device) | K033703 | Ideal 1 Orthodontic Bracket Adhesive | Dentsply Intl. | 2004 | — |
| +1 | K050750 | LC Bracket Adhesive System | Dentsply Intl. | 2005 | — |
| +1 | K040375 | Ideal 1 Orthodontic Band Cement | Dentsply Intl. | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 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 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? (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 |
|---|---|---|---|
| * | K933766 | High-Q-BondSummary page 1…Bracket adhesive and tooth conditioner resin (872.3750) PREDICATE DEVICES: t i-igh-Q-Bond Adhesive Resin Cement K933766 DEVICE DESCRIPTION: The IDEAL,® I ORTttOIDONTIC BRACKET ADIHESIVE system is a two-part light-cure system: an adhe… | 1994 |
What descends from it? (2)
2 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?
- Its one ancestor has no recall.
- Of its descendants, K050750 (Dentsply Intl., 2005) has gone furthest, with 0 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.
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?
Bonding of orthodontic brackets to
natural and artificial tooth surfaces
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033703 · printed Nov 6, 2026
Cite this page
510(k) Report. “K033703: Ideal 1 Orthodontic Bracket Adhesive.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033703
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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