510(k) · Cleared
ClearedROSA Bracket
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gni Co., Ltd. · NJM Bracket, Ceramic, Orthodontic
Cleared on Nov 15, 2019 as substantially equivalent to K150141 (Speed Dental Co., Ltd., 2015) after a 415-day review. Its family tree reaches back 2 generations to 2007. 1 later device descends from it.
- Decided
- Nov 15, 2019
- Review
- 415 days
- Class
- Class II
- Product code
- NJM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K073045 (2007). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK073045 Sapphire Ceramic BracketOrtho Technology, Inc. · 2007
- 1 generation backK150141 Orthodontics BracketSpeed Dental Co., Ltd. · 2015
- This deviceK182672 ROSA BracketGni Co., Ltd. · 2019
- Descendant · cites it directly · 0 of its ownK201410 VENUS Bracket, ROSE BracketGni Co., Ltd. · 2021
Most influential descendants
Showing 1 of 1 · See all- K201410VENUS Bracket, ROSE BracketGni Co., Ltd. · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K073045 | Sapphire Ceramic Bracket | Ortho Technology, Inc. | 2007 | — |
| −1 | K150141 | Orthodontics Bracket | Speed Dental Co., Ltd. | 2015 | — |
| 0 (this device) | K182672 | ROSA Bracket | Gni Co., Ltd. | 2019 | — |
| +1 | K201410 | VENUS Bracket, ROSE Bracket | Gni Co., Ltd. | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 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? (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 |
|---|---|---|---|
| * | K150141 | Orthodontics BracketSummary page 5…treatment has been completed. The devices are intended to be single use only Predicate Device Primary Manufacturer: Speed Dental Co., Ltd 510(k) Number: K150141 Trade Name: Orthodontics Bracket Common Name: Orthodontic Ceramic Brackets Regulation Name: Orthodontic Plastic Bracket Regulatio… | 2015 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K201410 | VENUS Bracket, ROSE Bracket | 2021 | 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 12 years and passes through 3 companies; a new generation was cleared every 7.8 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K201410 (Gni Co., Ltd., 2021) has gone furthest, with 0 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. 2019, 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?
This device is intended for the orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed. The devices are intended to be single use only
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K182672 · printed Nov 5, 2026
Cite this page
510(k) Report. “K182672: ROSA Bracket.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K182672
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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