510(k) · Cleared
ClearedClarity Advanced Ceramic Brackets
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
3M Unitek Corporation · NJM Bracket, Ceramic, Orthodontic
Cleared on Feb 17, 2011 as substantially equivalent to K062345 (Voco GmbH, 2006) and 3 other predicates after a 142-day review. Its family tree reaches back 3 generations to 1985. 15 later devices descend from it.
- Decided
- Feb 17, 2011
- Review
- 142 days
- Class
- Class II
- Product code
- NJM
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 3 generations to K852179 (1985). 6 ancestors in all. 15 later devices descend from it, 7 citing it directly.
- Root · 3 generations backK852179 Ceramic Orthodonit ApplianceGac Intl., Inc. · 1985
- 2 generations backK042178 Orthodontic Ceramic BracketsDentsply Intl. · 2004
- 1 generation backK082974 Mystique MB Ceramic BracketsDentsply Interntional · 2008
- This deviceK102803 Clarity Advanced Ceramic Brackets3M Unitek Corporation · 2011
- 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 · cites it directly · 2 of its ownK163467 C-Line Orthodontic Ceramic BracketBiocetec Co., Ltd. · 2017
- Descendant · 3 generations on · 1 of its ownK222764 LightForce Orthodontic SystemLightforce Orthodontics · 2022
- Descendant · 2 generations on · 1 of its ownK182193 S-LineBiocetec Co., Ltd. · 2019
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K160615Orthodontic Ceramic Brackets 1.1Tomy, Inc. · 2016 · cites it directly6descendants
- K181271Signature Orthodontic SystemSignature Orthodontics · 2018 · 2 generations on4descendants
- K163467C-Line Orthodontic Ceramic BracketBiocetec Co., Ltd. · 2017 · cites it directly2descendants
- K222764LightForce Orthodontic SystemLightforce Orthodontics · 2022 · 3 generations on1descendant
- K182193S-LineBiocetec Co., Ltd. · 2019 · 2 generations on1descendant
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 | K082974 | Mystique MB Ceramic Brackets | Dentsply Interntional | 2008 | — |
| 0 (this device) | K102803 | Clarity Advanced Ceramic Brackets | 3M Unitek Corporation | 2011 | — |
| +1 | K160615 | Orthodontic Ceramic Brackets 1.1 | Tomy, Inc. | 2016 | — |
| +2 | K181271 | Signature Orthodontic System | Signature Orthodontics | 2018 | — |
| +1 | K163467 | C-Line Orthodontic Ceramic Bracket | Biocetec Co., Ltd. | 2017 | — |
| +3 | K222764 | LightForce Orthodontic System | Lightforce Orthodontics | 2022 | — |
| +2 | K182193 | S-Line | Biocetec Co., Ltd. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 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? (4)
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 |
|---|---|---|---|
| * | K062345 | Ceramic BondSummary page 1…ceramic bracket Recommended Classification ...... Orthodontic ceramic bracket (21 CFR 872.5470, Product Code: NJM) Predicate Devices K062345, ClarityTM SL Self-Ligating Ceramic Brackets K944286, ClarityTM Meta-Reinforced Ceramic Brackets K950992, InVu® Aesthetic Braces… | 2006 |
| * | K944286 | Metal-Lined Transcend Ceramic BracketSummary page 1…thodontic ceramic bracket (21 CFR 872.5470, Product Code: NJM) Predicate Devices K062345, ClarityTM SL Self-Ligating Ceramic Brackets K944286, ClarityTM Meta-Reinforced Ceramic Brackets K950992, InVu® Aesthetic Braces K082974, Mystique@ MB Clear Braces Description of De… | 1994 |
| * | K950992 | Ceramaflex Bracket SystemSummary page 1…(21 CFR 872.5470, Product Code: NJM) Predicate Devices K062345, ClarityTM SL Self-Ligating Ceramic Brackets K944286, ClarityTM Meta-Reinforced Ceramic Brackets K950992, InVu® Aesthetic Braces K082974, Mystique@ MB Clear Braces Description of Device Clarity Advanced Ceramic Brackets are intended… | 1995 |
| * | K082974 | Mystique MB Ceramic BracketsSummary page 1…t Code: NJM) Predicate Devices K062345, ClarityTM SL Self-Ligating Ceramic Brackets K944286, ClarityTM Meta-Reinforced Ceramic Brackets K950992, InVu® Aesthetic Braces K082974, Mystique@ MB Clear Braces Description of Device Clarity Advanced Ceramic Brackets are intended to be bonded to teeth, upon whi… | 2008 |
What descends from it? (15)
See all 157 later devices cite 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 |
| K163467 | C-Line Orthodontic Ceramic Bracket | 2017 | 2 |
| K222847 | Ceramic Brackets Orthometric | 2023 | 0 |
| K180404 | 3M Clarity Ultra Self-Ligating Brackets and Adhesive Coated Appliance System | 2018 | 0 |
| K172845 | Symetri Clear | 2018 | 0 |
| K131197 | Edgewise Ceramic Brackets, Roth Ceramic Brackets | 2013 | 0 |
| K123092 | Ceramin Brackets Z | 2012 | 0 |
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 26 years and passes through 4 companies; a new generation was cleared every 4.2 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K160615 (Tomy, Inc., 2016) has gone furthest, with 6 descendants of its own.
- 1 other device also cites its predicate K062345.
How does its category compare?
All NJM devicesNJM Bracket, Ceramic, Orthodontic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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?
ClarityTm Advanced Ceramic Brackets are intended for use in orthodontic treatment. The brackets are affixed to teeth so that pressure can be exerted on the teeth.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102803 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102803: Clarity Advanced 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/K102803
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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