510(k) · Cleared
ClearedSapphire Ceramic Bracket
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ortho Technology, Inc. · NJM Bracket, Ceramic, Orthodontic
Cleared on Dec 18, 2007 after a 50-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 10 later devices descend from it.
- Decided
- Dec 18, 2007
- Review
- 50 days
- Class
- Class II
- Product code
- NJM
- Recalls
- None
- Predicates
- 0
10 later devices descend from it, 7 citing it directly.
- This deviceK073045 Sapphire Ceramic BracketOrtho Technology, Inc. · 2007
- Descendant · cites it directly · 2 of its ownK150141 Orthodontics BracketSpeed Dental Co., Ltd. · 2015
- Descendant · cites it directly · 2 of its ownK090567 Orthodontic Ceramic BracketStar Dentech Korea., Corp · 2009
- Descendant · 2 generations on · 1 of its ownK182672 ROSA BracketGni Co., Ltd. · 2019
- Descendant · cites it directly · 1 of its ownK163117 Alpha PureKoroad America · 2017
- Descendant · 3 generations on · 0 of its ownK201410 VENUS Bracket, ROSE BracketGni Co., Ltd. · 2021
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K150141Orthodontics BracketSpeed Dental Co., Ltd. · 2015 · cites it directly2descendants
- K090567Orthodontic Ceramic BracketStar Dentech Korea., Corp · 2009 · cites it directly2descendants
- K182672ROSA BracketGni Co., Ltd. · 2019 · 2 generations on1descendant
- K163117Alpha PureKoroad America · 2017 · cites it directly1descendant
- K201410VENUS Bracket, ROSE BracketGni Co., Ltd. · 2021 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K073045 | Sapphire Ceramic Bracket | Ortho Technology, Inc. | 2007 | — |
| +1 | K150141 | Orthodontics Bracket | Speed Dental Co., Ltd. | 2015 | — |
| +1 | K090567 | Orthodontic Ceramic Bracket | Star Dentech Korea., Corp | 2009 | — |
| +2 | K182672 | ROSA Bracket | Gni Co., Ltd. | 2019 | — |
| +1 | K163117 | Alpha Pure | Koroad America | 2017 | — |
| +3 | K201410 | VENUS Bracket, ROSE Bracket | Gni Co., Ltd. | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (10)
7 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?
- Of its descendants, K150141 (Speed Dental Co., Ltd., 2015) has gone furthest, with 2 descendants of its own.
How does its category compare?
All NJM devicesNJM Bracket, Ceramic, Orthodontic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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 | — |
https://510kreport.com/device/K073045 · printed Nov 6, 2026
Cite this page
510(k) Report. “K073045: Sapphire Ceramic Bracket.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K073045
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026