510(k) · Cleared
ClearedOrthodontic Ceramic Brackets
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 Dec 13, 2012 as substantially equivalent to K060837 (Dentsply International, 2006) and 1 other predicate after a 72-day review. Its family tree reaches back 3 generations to 1985. 7 later devices descend from it.
- Decided
- Dec 13, 2012
- Review
- 72 days
- Class
- Class II
- Product code
- NJM
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K852179 (1985). 4 ancestors in all. 7 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK852179 Ceramic Orthodonit ApplianceGac Intl., Inc. · 1985
- 2 generations backK042178 Orthodontic Ceramic BracketsDentsply Intl. · 2004
- 1 generation backK060837 IN-Ovation CDentsply International · 2006
- This deviceK123094 Orthodontic Ceramic BracketsTomy, Inc. · 2012
- Descendant · cites it directly · 6 of its ownK160615 Orthodontic Ceramic Brackets 1.1Tomy, Inc. · 2016
- Descendant · 2 generations on · 4 of its ownK181271 Signature Orthodontic SystemSignature Orthodontics · 2018
- Descendant · 3 generations on · 1 of its ownK222764 LightForce Orthodontic SystemLightforce Orthodontics · 2022
- Descendant · 3 generations on · 1 of its ownK183542 Signature Orthodontic SystemSignature Orthodontics · 2019
- Descendant · 4 generations on · 0 of its ownK232827 LightForce Orthodontic SystemLightforce Orthodontics · 2023
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K160615Orthodontic Ceramic Brackets 1.1Tomy, Inc. · 2016 · cites it directly6descendants
- K181271Signature Orthodontic SystemSignature Orthodontics · 2018 · 2 generations on4descendants
- K222764LightForce Orthodontic SystemLightforce Orthodontics · 2022 · 3 generations on1descendant
- K183542Signature Orthodontic SystemSignature Orthodontics · 2019 · 3 generations on1descendant
- K232827LightForce Orthodontic SystemLightforce Orthodontics · 2023 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K852179 | Ceramic Orthodonit Appliance | Gac Intl., Inc. | 1985 | — |
| −2 | K042178 | Orthodontic Ceramic Brackets | Dentsply Intl. | 2004 | — |
| −1 | K060837 | IN-Ovation C | Dentsply International | 2006 | — |
| 0 (this device) | K123094 | Orthodontic Ceramic Brackets | Tomy, Inc. | 2012 | — |
| +1 | K160615 | Orthodontic Ceramic Brackets 1.1 | Tomy, Inc. | 2016 | — |
| +2 | K181271 | Signature Orthodontic System | Signature Orthodontics | 2018 | — |
| +3 | K222764 | LightForce Orthodontic System | Lightforce Orthodontics | 2022 | — |
| +3 | K183542 | Signature Orthodontic System | Signature Orthodontics | 2019 | — |
| +4 | K232827 | LightForce Orthodontic System | Lightforce Orthodontics | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K060837 | IN-Ovation CSummary page 1…E OR PROPRIETARY NAME: ORTHODONTIC CERAMIC BRACKETS CLASSIFICATION NAME: Bracket, Ceramic, Orthodontic, 872.5470 PREDICATE DEVICES: In-Ovation Cceramic brackets (K060837) Mystique MB ceramic brackets (K082974) DEVICE DESCRIPTION: The ORTHODONTIC CERAMIC BRACKETS are designed to move teeth to… | 2006 |
| * | K082974 | Mystique MB Ceramic BracketsSummary page 1…ACKETS CLASSIFICATION NAME: Bracket, Ceramic, Orthodontic, 872.5470 PREDICATE DEVICES: In-Ovation Cceramic brackets (K060837) Mystique MB ceramic brackets (K082974) DEVICE DESCRIPTION: The ORTHODONTIC CERAMIC BRACKETS are designed to move teeth to improve their alignment. The ORTHODONTIC CE… | 2008 |
What descends from it? (7)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K160615 | Orthodontic Ceramic Brackets 1.1 | 2016 | 6 |
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 27 years and passes through 4 companies; a new generation was cleared every 6.7 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K160615 (Tomy, Inc., 2016) has gone furthest, with 6 descendants of its own.
- 8 other devices also cite its predicate K060837.
How does its category compare?
All NJM devicesNJM Bracket, Ceramic, Orthodontic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 are indicated for orthodontic movement of natural teeth, excluding mandibular bicuspid teeth.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123094 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123094: 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/K123094
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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