510(k) · Cleared
ClearedCDB Flip-Side-Clip Bracket
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cdb Corporation · NJM Bracket, Ceramic, Orthodontic
Cleared on Aug 7, 2009 as substantially equivalent to K080906 (Cdb Corporation, 2008) and 2 other predicates after a 58-day review. Its family tree reaches back 3 generations to 1985.
- Decided
- Aug 7, 2009
- Review
- 58 days
- Class
- Class II
- Product code
- NJM
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K852179 (1985). 6 ancestors in all. No later device cites it as a predicate yet.
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) | K091702 | CDB Flip-Side-Clip Bracket | Cdb Corporation | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 2004 | 1 | 0 |
| 2008 | 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 |
|---|---|---|---|
| * | K080906 | CDB ClipSummary page 1…dicate Devices(s): Company Product 510(k) CDB Corporation CDB Clip K080906 CDB Corporation Reflection Ceramic Dent… | 2008 |
| * | K922499 | Reflections - Ceramic Dental BracketSummary page 1…K080906 CDB Corporation Reflection Ceramic Dental Bracket K922499 Dentsply Int. In-Ovation C K060837 Device Description: CDB Fli… | 1992 |
| * | K060837 | IN-Ovation CSummary page 1…Dental Bracket K922499 Dentsply Int. In-Ovation C K060837 Device Description: CDB Flip-Slide-Clip Brackets are bonded to teeth to apply pressure t… | 2006 |
What descends from it?
No later submission names this one as a predicate yet.
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 24 years and passes through 4 companies; a new generation was cleared every 3.3 years on median.
- 2 of the 6 ancestors have a recall of any class.
- 1 other device also cites its predicate K080906.
How does its category compare?
All NJM devicesNJM Bracket, Ceramic, Orthodontic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 CDB Flip-Slide-Clip Bracket is indicated for orthodontic movement of natural teeth.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091702 · printed Nov 6, 2026
Cite this page
510(k) Report. “K091702: CDB Flip-Side-Clip Bracket.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K091702
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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