510(k) · Cleared
ClearedCeramic Brackets
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ortho Organizers, Inc. · NJM Bracket, Ceramic, Orthodontic
Cleared on May 19, 2011 as substantially equivalent to K861965 (Unitek Corp., 1986) and 2 other predicates after a 104-day review. Its family tree reaches back 1 generation to 1986.
- Decided
- May 19, 2011
- Review
- 104 days
- Class
- Class II
- Product code
- NJM
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K861965 (1986). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK861965 Unitek Ceramic Bracket SystemUnitek Corp. · 1986
- This deviceK110335 Ceramic BracketsOrtho Organizers, Inc. · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K861965 | Unitek Ceramic Bracket System | Unitek Corp. | 1986 | — |
| 0 (this device) | K110335 | Ceramic Brackets | Ortho Organizers, Inc. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 2006 | 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 |
|---|---|---|---|
| * | K861965 | Unitek Ceramic Bracket SystemSummary page 2…NJMV identification of Legally Marketed Device: (Device Equivalence) Proprietary Name: Transcend Ceramic Brackets 510K Number: K861965 Common or Usual Name: Ceramic Brackets Classification Name: Bracket, Ceramic, Orthodontic Classification Code:… | 1986 |
| * | K944286 | Metal-Lined Transcend Ceramic BracketSummary page 3…15 Proprietary Name: Transcend Ceramic Brackets 510K Number: K944286 Common or Usual Name: Ceramic Brackets Classification Name: Bracket, Ceramic, Orthodontic Classificatio… | 1994 |
| * | K062305 | Clarity Modified Ceramic BracketsSummary page 3…Code: DYW Device Manufacturer: 3M-Unitek Proprietary Name: Clarity Modified Ceramic Brackets 510K Number: K062305 Common or Usual Name: Ceramic Brackets Classification Name: Bracket, Ceramic, Orthodontic Classification… | 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?
- None of the 3 ancestors has a recall.
How does its category compare?
All NJM devicesNJM Bracket, Ceramic, Orthodontic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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?
These ceramic brackets will be used for correction of malocclusions as diagnosed and overseen by trained practitioners of orthodontics. These brackets will be directly bonded to teeth; will have inierface with the ardhwire to direct applied forces. These devices are intended for single use only and are not delivered in a sterile state.
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/K110335 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110335: 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/K110335
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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