510(k) · Cleared
ClearedOrthodontic Ceramic Brackets 1.1
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tomy, Inc. · NJM Bracket, Ceramic, Orthodontic
Cleared on Aug 26, 2016 as substantially equivalent to K102803 (3M Unitek Corporation, 2011) and 1 other predicate after a 176-day review. Its family tree reaches back 4 generations to 1985. 6 later devices descend from it.
- Decided
- Aug 26, 2016
- Review
- 176 days
- Class
- Class II
- Product code
- NJM
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K852179 (1985). 9 ancestors in all. 6 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 backK102803 Clarity Advanced Ceramic Brackets3M Unitek Corporation · 2011
- This deviceK160615 Orthodontic Ceramic Brackets 1.1Tomy, Inc. · 2016
- Descendant · cites it directly · 4 of its ownK181271 Signature Orthodontic SystemSignature Orthodontics · 2018
- Descendant · 2 generations on · 1 of its ownK222764 LightForce Orthodontic SystemLightforce Orthodontics · 2022
- Descendant · 2 generations on · 1 of its ownK183542 Signature Orthodontic SystemSignature Orthodontics · 2019
- Descendant · 3 generations on · 0 of its ownK232827 LightForce Orthodontic SystemLightforce Orthodontics · 2023
- Descendant · 3 generations on · 0 of its ownK200148 LightForce Orthodontic System (LFO System)Lightforce Orthodontics · 2020
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K181271Signature Orthodontic SystemSignature Orthodontics · 2018 · cites it directly4descendants
- K222764LightForce Orthodontic SystemLightforce Orthodontics · 2022 · 2 generations on1descendant
- K183542Signature Orthodontic SystemSignature Orthodontics · 2019 · 2 generations on1descendant
- K232827LightForce Orthodontic SystemLightforce Orthodontics · 2023 · 3 generations on0descendants
- K200148LightForce Orthodontic System (LFO System)Lightforce Orthodontics · 2020 · 3 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 | K102803 | Clarity Advanced Ceramic Brackets | 3M Unitek Corporation | 2011 | — |
| 0 (this device) | K160615 | Orthodontic Ceramic Brackets 1.1 | Tomy, Inc. | 2016 | — |
| +1 | K181271 | Signature Orthodontic System | Signature Orthodontics | 2018 | — |
| +2 | K222764 | LightForce Orthodontic System | Lightforce Orthodontics | 2022 | — |
| +2 | K183542 | Signature Orthodontic System | Signature Orthodontics | 2019 | — |
| +3 | K232827 | LightForce Orthodontic System | Lightforce Orthodontics | 2023 | — |
| +3 | K200148 | LightForce Orthodontic System (LFO System) | Lightforce Orthodontics | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 2006 | 2 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 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 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? (2)
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 |
|---|---|---|---|
| * | K102803 | Clarity Advanced Ceramic BracketsSummary page 4…equivalent to the following predicate devices with respect to intended use, materials, and design: 510(k) # Device Manufacturer K102803 Clarity Advanced Ceramic Brackets 3M Unitek Corp. (primary) K123094 Orthodontic Ceramic Brackets… | 2011 |
| * | K123094 | Orthodontic Ceramic BracketsSummary page 4…ials, and design: 510(k) # Device Manufacturer K102803 Clarity Advanced Ceramic Brackets 3M Unitek Corp. (primary) K123094 Orthodontic Ceramic Brackets TOMY, Inc. (secondary) ORTHODONTIC CERAMIC BRACKETS 1.1 are equivalent to Clarit… | 2012 |
What descends from it? (6)
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 31 years and passes through 5 companies; a new generation was cleared every 5.5 years on median.
- None of the 9 ancestors has a recall.
- Of its descendants, K181271 (Signature Orthodontics, 2018) has gone furthest, with 4 descendants of its own.
- 6 other devices also cite its predicate K102803.
How does its category compare?
All NJM devicesNJM Bracket, Ceramic, Orthodontic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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?
ORTHODONTIC CERAMIC BRACKETS 1.1 are indicated for orthodontic movement of natural teeth.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K160615 · printed Nov 6, 2026
Cite this page
510(k) Report. “K160615: Orthodontic Ceramic Brackets 1.1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K160615
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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