510(k) · Cleared
ClearedElation MB Metal Reinforced Plastic Bracket
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dentsply Interntional · DYW Bracket, Plastic, Orthodontic
Cleared on Jul 24, 2009 as substantially equivalent to K942826 (Gac Intl., Inc., 1994) and 2 other predicates after an 18-day review. Its family tree reaches back 4 generations to 1985. 4 later devices descend from it.
- Decided
- Jul 24, 2009
- Review
- 18 days
- Class
- Class II
- Product code
- DYW
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K852179 (1985). 5 ancestors in all. 4 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK852179 Ceramic Orthodonit ApplianceGac Intl., Inc. · 1985
- 3 generations backK042178 Orthodontic Ceramic BracketsDentsply Intl. · 2004
- 2 generations backK082974 Mystique MB Ceramic BracketsDentsply Interntional · 2008
- 1 generation backK090454 Allure MB Ceramic BracketsDentsply Interntional · 2009
- This deviceK092030 Elation MB Metal Reinforced Plastic BracketDentsply Interntional · 2009
- Descendant · cites it directly · 2 of its ownK140807 Composite Orthodontic BracketsOrtho Specialties · 2014
- Descendant · 2 generations on · 0 of its ownK201940 Braces on Demand BracketBraces on Demand, Inc. · 2020
- Descendant · cites it directly · 0 of its ownK180718 Orthodontic Plastic Brackets and AccessoriesTomy, Inc. · 2018
- Descendant · 2 generations on · 0 of its ownK150830 CompleClear Plastic Orthodontic Bracket and Wire ApplianceOracrew · 2016
Most influential descendants
Showing 4 of 4 · See all- K140807Composite Orthodontic BracketsOrtho Specialties · 2014 · cites it directly2descendants
- K201940Braces on Demand BracketBraces on Demand, Inc. · 2020 · 2 generations on0descendants
- K180718Orthodontic Plastic Brackets and AccessoriesTomy, Inc. · 2018 · cites it directly0descendants
- K150830CompleClear Plastic Orthodontic Bracket and Wire ApplianceOracrew · 2016 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K852179 | Ceramic Orthodonit Appliance | Gac Intl., Inc. | 1985 | — |
| −3 | K042178 | Orthodontic Ceramic Brackets | Dentsply Intl. | 2004 | — |
| −2 | K082974 | Mystique MB Ceramic Brackets | Dentsply Interntional | 2008 | — |
| −1 | K090454 | Allure MB Ceramic Brackets | Dentsply Interntional | 2009 | — |
| 0 (this device) | K092030 | Elation MB Metal Reinforced Plastic Bracket | Dentsply Interntional | 2009 | — |
| +1 | K140807 | Composite Orthodontic Brackets | Ortho Specialties | 2014 | — |
| +2 | K201940 | Braces on Demand Bracket | Braces on Demand, Inc. | 2020 | — |
| +1 | K180718 | Orthodontic Plastic Brackets and Accessories | Tomy, Inc. | 2018 | — |
| +2 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 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? (3)
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 |
|---|---|---|---|
| * | K942826 | Orthodonitc Metal Reinforced Plastic BracketSummary page 1…Device 510(k) Number Date Cleared GAC International Elation K942826 12/14/1994 DENTSPLY International Inc Mystique MB Ceramic K082974… | 1994 |
| * | K082974 | Mystique MB Ceramic BracketsSummary page 1…Elation K942826 12/14/1994 DENTSPLY International Inc Mystique MB Ceramic K082974 11/07/2008 Bracket DENTSPLY International Inc Allure MB C… | 2008 |
| * | K090454 | Allure MB Ceramic BracketsSummary page 1…K082974 11/07/2008 Bracket DENTSPLY International Inc Allure MB Ceramic Brackets K090454 03/20/2009 4. Description of Device: The marketed product Elation Metal Reinforced Plastic… | 2009 |
What descends from it? (4)
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 24 years and passes through 3 companies; a new generation was cleared every 4.2 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K140807 (Ortho Specialties, 2014) has gone furthest, with 2 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. 2009, 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?
Elation MB metal reinforced plastic brackets is indicated for orthodontic movement of natural teeth.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092030 · printed Nov 4, 2026
Cite this page
510(k) Report. “K092030: Elation MB Metal Reinforced Plastic Bracket.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K092030
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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