510(k) · Cleared
ClearedPre-Cemented Orthodontic Bracket System Extension
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dentsply Interntional · DYH Adhesive, Bracket And Tooth Conditioner, Resin
Cleared on May 22, 2008 as substantially equivalent to K061252 (Primus Consulting, 2007) and 1 other predicate after a 15-day review. Its family tree reaches back 3 generations to 1985. 1 later device descends from it.
- Decided
- May 22, 2008
- Review
- 15 days
- Class
- Class II
- Product code
- DYH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K852179 (1985). 5 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK852179 Ceramic Orthodonit ApplianceGac Intl., Inc. · 1985
- 2 generations backK042178 Orthodontic Ceramic BracketsDentsply Intl. · 2004
- 1 generation backK060837 IN-Ovation CDentsply International · 2006
- This deviceK081291 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 1 of 1 · See all- K093221Pre-Cemented Orthodontic Bracket System Extension IIDentsply Intl., Inc. · 2009 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K852179 | Ceramic Orthodonit Appliance | Gac Intl., Inc. | 1985 | — |
| −2 | K042178 | Orthodontic Ceramic Brackets | Dentsply Intl. | 2004 | — |
| −1 | K060837 | IN-Ovation C | Dentsply International | 2006 | — |
| 0 (this device) | K081291 | Pre-Cemented Orthodontic Bracket System Extension | Dentsply Interntional | 2008 | — |
| +1 | K093221 | Pre-Cemented Orthodontic Bracket System Extension II | Dentsply Intl., Inc. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (2)
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 |
|---|---|---|---|
| * | K061252 | Pre-Cemented Orthodontic Bracket SystemSummary page 1…0 DEVICE CLASS: II PRODUCT CODE: DYH PREDICATE DEVICES: Pre-Cemented Orthodontic Bracket System, K061252 In-Ovation TM C, K060837. DEVICE DESCRIPTION: The Pre-Cemented Orthodontic Bracket System… | 2007 |
| * | K060837 | IN-Ovation CSummary page 1…DYH PREDICATE DEVICES: Pre-Cemented Orthodontic Bracket System, K061252 In-Ovation TM C, K060837. DEVICE DESCRIPTION: The Pre-Cemented Orthodontic Bracket System Extension is comprised of pre-cemented ceramic and metal orthod… | 2006 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K093221 | Pre-Cemented Orthodontic Bracket System Extension II | 2009 | 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?
- The line of descent spans 23 years and passes through 4 companies; a new generation was cleared every 2.1 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K093221 (Dentsply Intl., Inc., 2009) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K061252.
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 | — |
What is it indicated for?
The Pre-Cemented Orthodontic Bracket System Extension is indicated for use in bonding orthodontic appliances for orthodontic treatment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081291 · printed Nov 4, 2026
Cite this page
510(k) Report. “K081291: Pre-Cemented Orthodontic Bracket System Extension.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K081291
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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