510(k) · Cleared
ClearedPre-Cemented Orthodontic Bracket System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Primus Consulting · DYH Adhesive, Bracket And Tooth Conditioner, Resin
Cleared on Feb 12, 2007 as substantially equivalent to K020394 (3M Unitek, 2002) after a 284-day review. Its family tree reaches back 1 generation to 2002. 2 later devices descend from it.
- Decided
- Feb 12, 2007
- Review
- 284 days
- Class
- Class II
- Product code
- DYH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K020394 (2002). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK020394 Apc Plus Adhesive3M Unitek · 2002
- This deviceK061252 Pre-Cemented Orthodontic Bracket SystemPrimus Consulting · 2007
- Descendant · cites it directly · 1 of its ownK081291 Pre-Cemented Orthodontic Bracket System ExtensionDentsply Interntional · 2008
- Descendant · cites it directly · 0 of its ownK093221 Pre-Cemented Orthodontic Bracket System Extension IIDentsply Intl., Inc. · 2009
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 | K020394 | Apc Plus Adhesive | 3M Unitek | 2002 | — |
| 0 (this device) | K061252 | Pre-Cemented Orthodontic Bracket System | Primus Consulting | 2007 | — |
| +1 | K081291 | Pre-Cemented Orthodontic Bracket System Extension | Dentsply Interntional | 2008 | — |
| +1 | K093221 | Pre-Cemented Orthodontic Bracket System Extension II | Dentsply Intl., Inc. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 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 13.9 · 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? (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 |
|---|---|---|---|
| * | K020394 | Apc Plus AdhesiveSummary page 1…ive resin and tooth conditioner, 872.3750 Resin impression tray material, 872.3670 Legally Marketed Predicate Devices APCTM Plus Adhesive K020394 Description of the Device: The Pre-Cemented Orthodontic Bracket System consists of pre- cemented orthodontic brackets and an op… | 2002 |
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?
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. 2007, 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 | — |
What is it indicated for?
Indicated for use in bonding orthodontic appliances for orthodontic treatment
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061252 · printed Nov 4, 2026
Cite this page
510(k) Report. “K061252: Pre-Cemented Orthodontic Bracket System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K061252
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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