510(k) · Cleared
ClearedComposite Orthodontic Brackets
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ortho Specialties · DYW Bracket, Plastic, Orthodontic
Cleared on Nov 12, 2014 as substantially equivalent to K092030 (Dentsply Interntional, 2009) and 1 other predicate after a 225-day review. Its family tree reaches back 5 generations to 1985. 2 later devices descend from it.
- Decided
- Nov 12, 2014
- Review
- 225 days
- Class
- Class II
- Product code
- DYW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K852179 (1985). 7 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK852179 Ceramic Orthodonit ApplianceGac Intl., Inc. · 1985
- 4 generations backK042178 Orthodontic Ceramic BracketsDentsply Intl. · 2004
- 3 generations backK082974 Mystique MB Ceramic BracketsDentsply Interntional · 2008
- 2 generations backK090454 Allure MB Ceramic BracketsDentsply Interntional · 2009
- 1 generation backK092030 Elation MB Metal Reinforced Plastic BracketDentsply Interntional · 2009
- This deviceK140807 Composite Orthodontic BracketsOrtho Specialties · 2014
- Descendant · cites it directly · 0 of its ownK201940 Braces on Demand BracketBraces on Demand, Inc. · 2020
- Descendant · cites it directly · 0 of its ownK150830 CompleClear Plastic Orthodontic Bracket and Wire ApplianceOracrew · 2016
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 |
|---|---|---|---|---|---|
| −5 | K852179 | Ceramic Orthodonit Appliance | Gac Intl., Inc. | 1985 | — |
| −4 | K042178 | Orthodontic Ceramic Brackets | Dentsply Intl. | 2004 | — |
| −3 | K082974 | Mystique MB Ceramic Brackets | Dentsply Interntional | 2008 | — |
| −2 | K090454 | Allure MB Ceramic Brackets | Dentsply Interntional | 2009 | — |
| −1 | K092030 | Elation MB Metal Reinforced Plastic Bracket | Dentsply Interntional | 2009 | — |
| 0 (this device) | K140807 | Composite Orthodontic Brackets | Ortho Specialties | 2014 | — |
| +1 | K201940 | Braces on Demand Bracket | Braces on Demand, Inc. | 2020 | — |
| +1 | K150830 | CompleClear Plastic Orthodontic Bracket and Wire Appliance | Oracrew | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2020 | 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 |
|---|---|---|---|
| * | K092030 | Elation MB Metal Reinforced Plastic BracketSummary page 4…DYW, Class II Device) LEGALLY MARKETED DEVICES TO WHICH EQUIVALENCE IS CLAIMED (PREDICATE DEVICE) [807.92(a) (3)]: • Elation MB ™ by Dentsply/GAC, Inc. K092030 • CDB Reflections Composite Bracket System, K973776 Page 12 of 104 3820 Ohio… | 2009 |
| * | K973776 | ReflectionsSummary page 4…CH EQUIVALENCE IS CLAIMED (PREDICATE DEVICE) [807.92(a) (3)]: • Elation MB ™ by Dentsply/GAC, Inc. K092030 • CDB Reflections Composite Bracket System, K973776 Page 12 of 104 3820 Ohio Avenue Suite #15 • St. Charles, IL 60174 • Phone: 630-443-0… | 1997 |
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?
- The line of descent spans 29 years and passes through 4 companies; a new generation was cleared every 4.2 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K201940 (Braces on Demand, Inc., 2020) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K092030.
How does its category compare?
All DYW devicesDYW Bracket, Plastic, Orthodontic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
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?
The Composite Brackets are intended for use as a clear, plastic bracket system to provide orthodontic movement of natural teeth.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140807 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140807: Composite Orthodontic Brackets.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140807
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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