510(k) · Cleared
ClearedBracePaste Adhesive
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
American Orthodontics · DYH Adhesive, Bracket And Tooth Conditioner, Resin
Cleared on Oct 14, 2016 as substantially equivalent to K880393 (Unitek Corp., 1988) after a 206-day review. Its family tree reaches back 1 generation to 1988. 1 later device descends from it.
- Decided
- Oct 14, 2016
- Review
- 206 days
- Class
- Class II
- Product code
- DYH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K880393 (1988). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK880393 Transbond Light Cured Orthodontic AdhesiveUnitek Corp. · 1988
- This deviceK160782 BracePaste AdhesiveAmerican Orthodontics · 2016
- Descendant · cites it directly · 0 of its ownK214054 TP Orthodontics Light-Cure Adhesive System, TP Orthodontics…Tp Orthodontics, Inc. · 2022
Most influential descendants
Showing 1 of 1 · See all- K214054TP Orthodontics Light-Cure Adhesive System, TP Orthodontics Pre-Applied Adhesive, TP…Tp Orthodontics, Inc. · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K880393 | Transbond Light Cured Orthodontic Adhesive | Unitek Corp. | 1988 | — |
| 0 (this device) | K160782 | BracePaste Adhesive | American Orthodontics | 2016 | — |
| +1 | K214054 | TP Orthodontics Light-Cure Adhesive System, TP Orthodontics Pre-Applied… | Tp Orthodontics, Inc. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 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 |
|---|---|---|---|
| * | K880393 | Transbond Light Cured Orthodontic AdhesiveSummary page 4…Regulation Number (21CFR): 872.3750 Predicate Device Information: Product/Trade Name: Transbond™ XT Manufacturer: 3M Unitek 510(k) #: K880393 Classification: Class II Classification Name: Bracket Adhesive Resin and Tooth Conditioner Product… | 1988 |
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 |
|---|---|---|---|
| K214054 | TP Orthodontics Light-Cure Adhesive System, TP Orthodontics Pre-Applied Adhesive, TP… | 2022 | 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?
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. 2016, 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?
American Orthodontics’ BracePaste™ Adhesive is intended for use as an orthodontic bonding agent for Metal Brackets, Ceramic Brackets and Buccal Tubes to the tooth's surface.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K160782 · printed Nov 4, 2026
Cite this page
510(k) Report. “K160782: BracePaste Adhesive.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K160782
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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