510(k) · Cleared
ClearedMystique MB Ceramic Brackets
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dentsply Interntional · NJM Bracket, Ceramic, Orthodontic
Cleared on Nov 7, 2008 as substantially equivalent to K042178 (Dentsply Intl., 2004) after a 32-day review. Its family tree reaches back 2 generations to 1985. 23 later devices descend from it.
- Decided
- Nov 7, 2008
- Review
- 32 days
- Class
- Class II
- Product code
- NJM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K852179 (1985). 23 later devices descend from it, 4 citing it directly.
- Root · 2 generations backK852179 Ceramic Orthodonit ApplianceGac Intl., Inc. · 1985
- 1 generation backK042178 Orthodontic Ceramic BracketsDentsply Intl. · 2004
- This deviceK082974 Mystique MB Ceramic BracketsDentsply Interntional · 2008
- Descendant · cites it directly · 15 of its ownK102803 Clarity Advanced Ceramic Brackets3M Unitek Corporation · 2011
- Descendant · cites it directly · 7 of its ownK123094 Orthodontic Ceramic BracketsTomy, Inc. · 2012
- Descendant · 2 generations on · 6 of its ownK160615 Orthodontic Ceramic Brackets 1.1Tomy, Inc. · 2016
- Descendant · cites it directly · 5 of its ownK090454 Allure MB Ceramic BracketsDentsply Interntional · 2009
- Descendant · 3 generations on · 4 of its ownK181271 Signature Orthodontic SystemSignature Orthodontics · 2018
Showing 5 of 23 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 23 · See all- K102803Clarity Advanced Ceramic Brackets3M Unitek Corporation · 2011 · cites it directly15descendants
- K123094Orthodontic Ceramic BracketsTomy, Inc. · 2012 · cites it directly7descendants
- K160615Orthodontic Ceramic Brackets 1.1Tomy, Inc. · 2016 · 2 generations on6descendants
- K090454Allure MB Ceramic BracketsDentsply Interntional · 2009 · cites it directly5descendants
- K181271Signature Orthodontic SystemSignature Orthodontics · 2018 · 3 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K852179 | Ceramic Orthodonit Appliance | Gac Intl., Inc. | 1985 | — |
| −1 | K042178 | Orthodontic Ceramic Brackets | Dentsply Intl. | 2004 | — |
| 0 (this device) | K082974 | Mystique MB Ceramic Brackets | Dentsply Interntional | 2008 | — |
| +1 | K102803 | Clarity Advanced Ceramic Brackets | 3M Unitek Corporation | 2011 | — |
| +1 | K123094 | Orthodontic Ceramic Brackets | Tomy, Inc. | 2012 | — |
| +2 | K160615 | Orthodontic Ceramic Brackets 1.1 | Tomy, Inc. | 2016 | — |
| +1 | K090454 | Allure MB Ceramic Brackets | Dentsply Interntional | 2009 | — |
| +3 | K181271 | Signature Orthodontic System | Signature Orthodontics | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 4 | 0 |
| 2019 | 3 | 0 |
| 2020 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 3 | 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 NJM? 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 NJM device
- #1 K222764 LightForce Orthodontic Systemscore 8.5 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K042178 | Orthodontic Ceramic BracketsSummary page 1…Brackets CLASSIFICATION NAME: Orthodontic Ceramic Brackets 872.5470 PREDICATE DEVICES: Orthodontic Ceramic Brackets K042178 )EVICE DESCRIPTION: The Orthodontic Ceramic Bracket is in commercial distribution and consists of a chemically treated base. T… | 2004 |
What descends from it? (23)
See all 234 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 23 years and passes through 3 companies; a new generation was cleared every 19.0 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K102803 (3M Unitek Corporation, 2011) has gone furthest, with 15 descendants of its own.
- 3 other devices also cite its predicate K042178.
How does its category compare?
All NJM devicesNJM Bracket, Ceramic, Orthodontic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · NJM
5in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · NJM
1in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NJM
1in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NJM
1in 2025
MAUDE reports naming product code NJM, 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 | 1 | — | 0 | 0 |
| 2008 | 4 | 134 | 0 | 0 |
| 2009 | 4 | 61 | 0 | 1 |
| 2010 | 1 | — | 0 | 2 |
| 2011 | 4 | 122 | 0 | 1 |
| 2012 | 6 | 90 | 0 | 1 |
| 2013 | 3 | 123 | 1 | 6 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 3 | 234 | 0 | 0 |
| 2016 | 3 | 176 | 0 | 2 |
| 2017 | 3 | 183 | 0 | 2 |
| 2018 | 4 | 76 | 0 | 2 |
| 2019 | 6 | 200 | 0 | 0 |
| 2020 | 2 | — | 0 | 1 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 2 | — | 0 | 0 |
| 2023 | 5 | 1 | 0 | 1 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Indicated for orthodontic movement of natural teeth, excluding mandibular bicuspid teeth.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082974 · printed Nov 5, 2026
Cite this page
510(k) Report. “K082974: Mystique MB Ceramic Brackets.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K082974
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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