510(k) · Cleared
Recalled · 2011CDB Clip
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 Oct 17, 2008 as substantially equivalent to K042905 (Dentsply Intl., 2004) after a 199-day review. Its family tree reaches back 1 generation to 2004. 2 later devices descend from it. It has been recalled once.
- Decided
- Oct 17, 2008
- Review
- 199 days
- Class
- Class II
- Product code
- NJM
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K042905 (2004). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK042905 Neo-Clip Orthodontic Bracket AccessoryDentsply Intl. · 2004
- This deviceK080906 CDB ClipCdb Corporation · 2008
- Descendant · cites it directly · 0 of its ownK180718 Orthodontic Plastic Brackets and AccessoriesTomy, Inc. · 2018
- Descendant · cites it directly · 0 of its ownK091702 CDB Flip-Side-Clip BracketCdb Corporation · 2009
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K042905 | Neo-Clip Orthodontic Bracket Accessory | Dentsply Intl. | 2004 | — |
| 0 (this device) | K080906 | CDB Clip | Cdb Corporation | 2008 | — |
| +1 | K180718 | Orthodontic Plastic Brackets and Accessories | Tomy, Inc. | 2018 | — |
| +1 | K091702 | CDB Flip-Side-Clip Bracket | Cdb Corporation | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2018 | 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 |
|---|---|---|---|
| * | K042905 | Neo-Clip Orthodontic Bracket AccessorySummary page 1…ntal Regulation Number: 21 CFR 872.5470 Predicate Device(s) 510(k) Number Device Manufacturer K042905 NEO-CLIP ORTHODONTIC Dentsply International BRACKET ACC… | 2004 |
What descends from it? (2)
2 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 3, 2011 | Not classified | Z-2977-2011 | Software design | A potential safety rick related to transferring reference images for offset calculation between a syngo RT Therapist v 4.2 or a syngo RT Oncologist 4.2 and other versions of the COHERENCE/syn go RT Therapist or Oncologist or vice versa.… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
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 CDB Clip, commonly known as an orthodontic ligating clip, is an orthodontic bracket accessory. It attaches to the orthodontic bracket to hold the archwire firmly in the slot Together they facilitate the orthodontic movement of teeth.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080906 · printed Nov 3, 2026
Cite this page
510(k) Report. “K080906: CDB Clip.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K080906
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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