510(k) · Cleared
ClearedAvex CX2 and Avex CXI2 Ceramic Brackets
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Opal Orthodontics by Ultradent Products, Inc. · NJM Bracket, Ceramic, Orthodontic
Cleared on Feb 3, 2012 as substantially equivalent to K973776 (Cdb Corp., 1997) after an 81-day review. Its family tree reaches back 1 generation to 1997. 1 later device descends from it.
- Decided
- Feb 3, 2012
- Review
- 81 days
- Class
- Class II
- Product code
- NJM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K973776 (1997). 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K152779Avex CX2Opal Orthodontics by Ultradent Products · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K973776 | Reflections | Cdb Corp. | 1997 | — |
| 0 (this device) | K113334 | Avex CX2 and Avex CXI2 Ceramic Brackets | Opal Orthodontics by Ultradent Products, Inc. | 2012 | — |
| +1 | K152779 | Avex CX2 | Opal Orthodontics by Ultradent Products | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 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 |
|---|---|---|---|
| * | K973776 | ReflectionsSummary page 1…: Class 11 Product Code: NJM L egally Ma rketed Predicate Devices to Which Equivalence is Claimed The predicate devices are: K973776 Reflections Ceramic Brackets by CDB Corporation. AVEX® CX 2 and AVEX* CXi 2 ceramic brackets are substantially equiva… | 1997 |
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 |
|---|---|---|---|
| K152779 | Avex CX2 | 2015 | 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?
How does its category compare?
All NJM devicesNJM Bracket, Ceramic, Orthodontic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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?
AVEX®I CX, and AVEX® CXi 2 Ceramic Brackets are intended for
use in Orthodontic treatment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113334 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113334: Avex CX2 and Avex CXI2 Ceramic Brackets.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113334
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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