510(k) · Cleared
ClearedDamon 4CLEAR
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ormco Corp. · NJM Bracket, Ceramic, Orthodontic
Cleared on Sep 24, 2008 after a 127-day review. The FDA summary names its predicate without a number. 6 later devices descend from it.
- Decided
- Sep 24, 2008
- Review
- 127 days
- Class
- Class II
- Product code
- NJM
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 4 citing it directly.
- This deviceK081415 Damon 4CLEAROrmco Corp. · 2008
- Descendant · cites it directly · 1 of its ownK173440 Carriere SLX 3D ClearOrtho Organizers, Inc. · 2018
- Descendant · cites it directly · 1 of its ownK111234 Click-ITTp Orthodontics, Inc. · 2011
- Descendant · 2 generations on · 0 of its ownK230225 DynaFlex Clear Brackets & ButtonsDyna Flex · 2023
- Descendant · cites it directly · 0 of its ownK192202 Clear21World Class Technology Corporation · 2019
- Descendant · cites it directly · 0 of its ownK172845 Symetri ClearOrmco Corporation · 2018
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K173440Carriere SLX 3D ClearOrtho Organizers, Inc. · 2018 · cites it directly1descendant
- K111234Click-ITTp Orthodontics, Inc. · 2011 · cites it directly1descendant
- K230225DynaFlex Clear Brackets & ButtonsDyna Flex · 2023 · 2 generations on0descendants
- K192202Clear21World Class Technology Corporation · 2019 · cites it directly0descendants
- K172845Symetri ClearOrmco Corporation · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K081415 | Damon 4CLEAR | Ormco Corp. | 2008 | — |
| +1 | K173440 | Carriere SLX 3D Clear | Ortho Organizers, Inc. | 2018 | — |
| +1 | K111234 | Click-IT | Tp Orthodontics, Inc. | 2011 | — |
| +2 | K230225 | DynaFlex Clear Brackets & Buttons | Dyna Flex | 2023 | — |
| +1 | K192202 | Clear21 | World Class Technology Corporation | 2019 | — |
| +1 | K172845 | Symetri Clear | Ormco Corporation | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 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? (3)
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 |
|---|---|---|---|
| * | — | Lumina Named without a submission number | |
| * | — | In-Ovation C Named without a submission number | |
| * | — | Clarity Modified Ceramic Bracket Named without a submission number |
What descends from it? (6)
4 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, K173440 (Ortho Organizers, Inc., 2018) has gone furthest, with 1 descendant 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. 2008, 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?
The Damon 4Clear is a ceramic bracket system intended to aid in the movement of patient teeth during orthodontic treatment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081415 · printed Nov 6, 2026
Cite this page
510(k) Report. “K081415: Damon 4CLEAR.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K081415
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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