510(k) · Cleared
ClearedMetal-Lined Transcend Ceramic Bracket
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Unitek Corp. · DYW Bracket, Plastic, Orthodontic
Cleared on Nov 29, 1994 after an 88-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 17 later devices descend from it.
- Decided
- Nov 29, 1994
- Review
- 88 days
- Class
- Class II
- Product code
- DYW
- Recalls
- None
- Predicates
- 0
17 later devices descend from it, 2 citing it directly.
- This deviceK944286 Metal-Lined Transcend Ceramic BracketUnitek Corp. · 1994
- Descendant · cites it directly · 15 of its ownK102803 Clarity Advanced Ceramic Brackets3M Unitek Corporation · 2011
- Descendant · 2 generations on · 6 of its ownK160615 Orthodontic Ceramic Brackets 1.1Tomy, Inc. · 2016
- Descendant · 3 generations on · 4 of its ownK181271 Signature Orthodontic SystemSignature Orthodontics · 2018
- Descendant · 2 generations on · 2 of its ownK163467 C-Line Orthodontic Ceramic BracketBiocetec Co., Ltd. · 2017
- Descendant · 4 generations on · 1 of its ownK222764 LightForce Orthodontic SystemLightforce Orthodontics · 2022
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · See all- K102803Clarity Advanced Ceramic Brackets3M Unitek Corporation · 2011 · cites it directly15descendants
- K160615Orthodontic Ceramic Brackets 1.1Tomy, Inc. · 2016 · 2 generations on6descendants
- K181271Signature Orthodontic SystemSignature Orthodontics · 2018 · 3 generations on4descendants
- K163467C-Line Orthodontic Ceramic BracketBiocetec Co., Ltd. · 2017 · 2 generations on2descendants
- K222764LightForce Orthodontic SystemLightforce Orthodontics · 2022 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K944286 | Metal-Lined Transcend Ceramic Bracket | Unitek Corp. | 1994 | — |
| +1 | K102803 | Clarity Advanced Ceramic Brackets | 3M Unitek Corporation | 2011 | — |
| +2 | K160615 | Orthodontic Ceramic Brackets 1.1 | Tomy, Inc. | 2016 | — |
| +3 | K181271 | Signature Orthodontic System | Signature Orthodontics | 2018 | — |
| +2 | K163467 | C-Line Orthodontic Ceramic Bracket | Biocetec Co., Ltd. | 2017 | — |
| +4 | K222764 | LightForce Orthodontic System | Lightforce Orthodontics | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 3 | 0 |
| 2019 | 3 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 3 | 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 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’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (17)
See all 172 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, K102803 (3M Unitek Corporation, 2011) has gone furthest, with 15 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/K944286 · printed Nov 6, 2026
Cite this page
510(k) Report. “K944286: Metal-Lined Transcend Ceramic Bracket.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K944286
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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