510(k) · Cleared
ClearedOrthodonitc Metal Reinforced Plastic Bracket
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gac Intl., Inc. · DYW Bracket, Plastic, Orthodontic
Cleared on Dec 14, 1994 after a 183-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 5 later devices descend from it.
- Decided
- Dec 14, 1994
- Review
- 183 days
- Class
- Class II
- Product code
- DYW
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 1 citing it directly.
- This deviceK942826 Orthodonitc Metal Reinforced Plastic BracketGac Intl., Inc. · 1994
- Descendant · cites it directly · 4 of its ownK092030 Elation MB Metal Reinforced Plastic BracketDentsply Interntional · 2009
- Descendant · 2 generations on · 2 of its ownK140807 Composite Orthodontic BracketsOrtho Specialties · 2014
- Descendant · 3 generations on · 0 of its ownK201940 Braces on Demand BracketBraces on Demand, Inc. · 2020
- Descendant · 2 generations on · 0 of its ownK180718 Orthodontic Plastic Brackets and AccessoriesTomy, Inc. · 2018
- Descendant · 3 generations on · 0 of its ownK150830 CompleClear Plastic Orthodontic Bracket and Wire ApplianceOracrew · 2016
Most influential descendants
Showing 5 of 5 · See all- K092030Elation MB Metal Reinforced Plastic BracketDentsply Interntional · 2009 · cites it directly4descendants
- K140807Composite Orthodontic BracketsOrtho Specialties · 2014 · 2 generations on2descendants
- K201940Braces on Demand BracketBraces on Demand, Inc. · 2020 · 3 generations on0descendants
- K180718Orthodontic Plastic Brackets and AccessoriesTomy, Inc. · 2018 · 2 generations on0descendants
- K150830CompleClear Plastic Orthodontic Bracket and Wire ApplianceOracrew · 2016 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K942826 | Orthodonitc Metal Reinforced Plastic Bracket | Gac Intl., Inc. | 1994 | — |
| +1 | K092030 | Elation MB Metal Reinforced Plastic Bracket | Dentsply Interntional | 2009 | — |
| +2 | K140807 | Composite Orthodontic Brackets | Ortho Specialties | 2014 | — |
| +3 | K201940 | Braces on Demand Bracket | Braces on Demand, Inc. | 2020 | — |
| +2 | K180718 | Orthodontic Plastic Brackets and Accessories | Tomy, Inc. | 2018 | — |
| +3 | K150830 | CompleClear Plastic Orthodontic Bracket and Wire Appliance | Oracrew | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K092030 | Elation MB Metal Reinforced Plastic Bracket | 2009 | 4 |
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, K092030 (Dentsply Interntional, 2009) has gone furthest, with 4 descendants of its own.
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 | — |
https://510kreport.com/device/K942826 · printed Nov 6, 2026
Cite this page
510(k) Report. “K942826: Orthodonitc Metal Reinforced Plastic Bracket.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K942826
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026