510(k) · Cleared
ClearedApc Plus Adhesive
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
3M Unitek · DYH Adhesive, Bracket And Tooth Conditioner, Resin
Cleared on Apr 12, 2002 after a 65-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 6 later devices descend from it.
- Decided
- Apr 12, 2002
- Review
- 65 days
- Class
- Class II
- Product code
- DYH
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 4 citing it directly.
- This deviceK020394 Apc Plus Adhesive3M Unitek · 2002
- Descendant · cites it directly · 2 of its ownK061252 Pre-Cemented Orthodontic Bracket SystemPrimus Consulting · 2007
- Descendant · 2 generations on · 1 of its ownK081291 Pre-Cemented Orthodontic Bracket System ExtensionDentsply Interntional · 2008
- Descendant · cites it directly · 0 of its ownK214054 TP Orthodontics Light-Cure Adhesive System, TP Orthodontics…Tp Orthodontics, Inc. · 2022
- Descendant · cites it directly · 0 of its ownK113197 Apc Flash-Free Adhesive3M Unitek Corporation · 2012
- Descendant · 2 generations on · 0 of its ownK093221 Pre-Cemented Orthodontic Bracket System Extension IIDentsply Intl., Inc. · 2009
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K061252Pre-Cemented Orthodontic Bracket SystemPrimus Consulting · 2007 · cites it directly2descendants
- K081291Pre-Cemented Orthodontic Bracket System ExtensionDentsply Interntional · 2008 · 2 generations on1descendant
- K214054TP Orthodontics Light-Cure Adhesive System, TP Orthodontics Pre-Applied Adhesive, TP…Tp Orthodontics, Inc. · 2022 · cites it directly0descendants
- K113197Apc Flash-Free Adhesive3M Unitek Corporation · 2012 · cites it directly0descendants
- K093221Pre-Cemented Orthodontic Bracket System Extension IIDentsply Intl., Inc. · 2009 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K020394 | Apc Plus Adhesive | 3M Unitek | 2002 | — |
| +1 | K061252 | Pre-Cemented Orthodontic Bracket System | Primus Consulting | 2007 | — |
| +2 | K081291 | Pre-Cemented Orthodontic Bracket System Extension | Dentsply Interntional | 2008 | — |
| +1 | K214054 | TP Orthodontics Light-Cure Adhesive System, TP Orthodontics Pre-Applied… | Tp Orthodontics, Inc. | 2022 | — |
| +1 | K113197 | Apc Flash-Free Adhesive | 3M Unitek Corporation | 2012 | — |
| +2 | K093221 | Pre-Cemented Orthodontic Bracket System Extension II | Dentsply Intl., Inc. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
| 2022 | 1 | 0 |
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
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (6)
4 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?
- Of its descendants, K061252 (Primus Consulting, 2007) has gone furthest, with 2 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?
3M™ Unitek™ APC™ Plus Adhesive is indicated for use in orthodontic appliance application and bonding for orthodontic treatment.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K020394 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020394: Apc Plus Adhesive.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020394
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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