510(k) · Cleared
ClearedEverstick a&O
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stick Tech, Ltd. · DYW Bracket, Plastic, Orthodontic
Cleared on Mar 21, 2006 as substantially equivalent to K052477 (Ormco Corp., 2005) and 1 other predicate after a 246-day review. Its family tree reaches back 3 generations to 2001.
- Decided
- Mar 21, 2006
- Review
- 246 days
- Class
- Class II
- Product code
- DYW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K003333 (2001). 4 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K003333 | STICK | Stick Tech, Ltd. | 2001 | — |
| −2 | K011788 | Everstick | Stick Tech, Ltd. | 2001 | — |
| −1 | K030072 | Everstick Perio | Stick Tech, Ltd. | 2003 | — |
| 0 (this device) | K051953 | Everstick a&O | Stick Tech, Ltd. | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 DYW? 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 DYW device
- #1 K252760 Carriere® Motion Pro® Clear Bite Correctorscore 10.4 · 1 generation · 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 |
|---|---|---|---|
| * | K052477 | Damon 3 Modified Cleared while this submission was under review Summary page 1…Stick A&O is substantially equivalent to its predicate device Damon 3(510(k) ) number K052477) by Ormco Inc. in its clinical use. The composition of everStick® A&O is equal to everStick® PERIO (510(k) number K030072). By c… | 2005 |
| * | K030072 | Everstick PerioSummary page 1…) number K052477) by Ormco Inc. in its clinical use. The composition of everStick® A&O is equal to everStick® PERIO (510(k) number K030072). By comparing the clinical usage of everStick A&O with the plastic bracket Damon 3and by comparing the ingredients of e… | 2003 |
What descends from it?
No later submission names this one as a predicate yet.
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 5 years and passes through 1 company; a new generation was cleared every 1.4 years on median.
- 1 of the 4 ancestors has a recall of any class.
How does its category compare?
All DYW devicesDYW Bracket, Plastic, Orthodontic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DYW
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DYW
372in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DYW
2in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DYW
1in 2017
MAUDE reports naming product code DYW, 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 | 2 | — | 0 | 2 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 1 | — | 2 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 2 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 4 |
| 2015 | 0 | — | 0 | 4 |
| 2016 | 3 | 372 | 0 | 0 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 2 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 2 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
For orthodontic splinting
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051953 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051953: Everstick a&O.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051953
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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