510(k) · Cleared
ClearedFastbraces Ceramic Brackets
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Orthodontic Design and Production, Inc. · NJM Bracket, Ceramic, Orthodontic
Cleared on Jun 7, 2013 as substantially equivalent to K922499 (Cdb Corp., 1992) after a 106-day review. Its family tree reaches back 1 generation to 1992. 1 later device descends from it.
- Decided
- Jun 7, 2013
- Review
- 106 days
- Class
- Class II
- Product code
- NJM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K922499 (1992). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK922499 Reflections - Ceramic Dental BracketCdb Corp. · 1992 · Recalled
- This deviceK130446 Fastbraces Ceramic BracketsOrthodontic Design and Production, Inc. · 2013
- Descendant · cites it directly · 0 of its ownK132368 Vapor Ceramic BracketOrthodontic Design and Production, Inc. · 2013
Most influential descendants
Showing 1 of 1 · See all- K132368Vapor Ceramic BracketOrthodontic Design and Production, Inc. · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K922499 | Reflections - Ceramic Dental Bracket | Cdb Corp. | 1992 | 1 |
| 0 (this device) | K130446 | Fastbraces Ceramic Brackets | Orthodontic Design and Production, Inc. | 2013 | — |
| +1 | K132368 | Vapor Ceramic Bracket | Orthodontic Design and Production, Inc. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 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 |
|---|---|---|---|
| * | K922499 | Reflections - Ceramic Dental BracketSummary page 1…amic Brackets Common Name: Orthodontic Ceramic Bracket Classification Name: Orthodontic Ceramic Bracket, Class I (21 CFR 872.5470, Product Code: NJM) Predicate Device: K922499, Reflections Ceramic Dental Bracket Description of Device: Ceramic orthodontic brackets are small devices that are intended to… | 1992 |
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 |
|---|---|---|---|
| K132368 | Vapor Ceramic Bracket | 2013 | 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. 2013, 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?
FastBraces® Ceramic Brackets are indicated for orthodontic movement of natural teeth.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K130446 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130446: Fastbraces 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/K130446
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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