510(k) · Cleared
ClearedOrthodontic Ceramic Brackets
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dentsply Intl. · NJM Bracket, Ceramic, Orthodontic
Cleared on Aug 30, 2004 as substantially equivalent to K852179 (Gac Intl., Inc., 1985) after a 19-day review. Its family tree reaches back 1 generation to 1985. 38 later devices descend from it.
- Decided
- Aug 30, 2004
- Review
- 19 days
- Class
- Class II
- Product code
- NJM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K852179 (1985). 38 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK852179 Ceramic Orthodonit ApplianceGac Intl., Inc. · 1985
- This deviceK042178 Orthodontic Ceramic BracketsDentsply Intl. · 2004
- Descendant · cites it directly · 23 of its ownK082974 Mystique MB Ceramic BracketsDentsply Interntional · 2008
- Descendant · cites it directly · 20 of its ownK060837 IN-Ovation CDentsply International · 2006
- Descendant · 2 generations on · 15 of its ownK102803 Clarity Advanced Ceramic Brackets3M Unitek Corporation · 2011
- Descendant · 2 generations on · 7 of its ownK123094 Orthodontic Ceramic BracketsTomy, Inc. · 2012
- Descendant · 3 generations on · 6 of its ownK160615 Orthodontic Ceramic Brackets 1.1Tomy, Inc. · 2016
Showing 5 of 38 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 38 · See all- K082974Mystique MB Ceramic BracketsDentsply Interntional · 2008 · cites it directly23descendants
- K060837IN-Ovation CDentsply International · 2006 · cites it directly20descendants
- K102803Clarity Advanced Ceramic Brackets3M Unitek Corporation · 2011 · 2 generations on15descendants
- K123094Orthodontic Ceramic BracketsTomy, Inc. · 2012 · 2 generations on7descendants
- K160615Orthodontic Ceramic Brackets 1.1Tomy, Inc. · 2016 · 3 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K852179 | Ceramic Orthodonit Appliance | Gac Intl., Inc. | 1985 | — |
| 0 (this device) | K042178 | Orthodontic Ceramic Brackets | Dentsply Intl. | 2004 | — |
| +1 | K082974 | Mystique MB Ceramic Brackets | Dentsply Interntional | 2008 | — |
| +1 | K060837 | IN-Ovation C | Dentsply International | 2006 | — |
| +2 | K102803 | Clarity Advanced Ceramic Brackets | 3M Unitek Corporation | 2011 | — |
| +2 | K123094 | Orthodontic Ceramic Brackets | Tomy, Inc. | 2012 | — |
| +3 | K160615 | Orthodontic Ceramic Brackets 1.1 | Tomy, Inc. | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 5 | 0 |
| 2011 | 2 | 0 |
| 2012 | 4 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2016 | 3 | 0 |
| 2017 | 1 | 0 |
| 2018 | 4 | 0 |
| 2019 | 3 | 0 |
| 2020 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 4 | 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 |
|---|---|---|---|
| * | K852179 | Ceramic Orthodonit ApplianceSummary page 1…ASSIFICATION NAME: Orthodontic Bracket, 872.5470 PREDICATE DEVICES: Ceramic Orthodontic Bracket, K852179 DESCRIPTION OF DEVICE: The ORTHODONTIC CERAMIC BRACKETS are bonded to teeth to apply pressure to the tooth, transmitted throu… | 1985 |
What descends from it? (38)
See all 384 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?
How does its category compare?
All NJM devicesNJM Bracket, Ceramic, Orthodontic: FDA decisions, review times, recalls and adverse event reports over 20 years.
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/K042178 · printed Nov 6, 2026
Cite this page
510(k) Report. “K042178: Orthodontic Ceramic Brackets.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042178
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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