510(k) · Cleared
ClearedEdgewise Ceramic Brackets, Roth Ceramic Brackets
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dental Morelli · NJM Bracket, Ceramic, Orthodontic
Cleared on Aug 27, 2013 as substantially equivalent to K102803 (3M Unitek Corporation, 2011) after a 123-day review. Its family tree reaches back 4 generations to 1985.
- Decided
- Aug 27, 2013
- Review
- 123 days
- Class
- Class II
- Product code
- NJM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K852179 (1985). 7 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK852179 Ceramic Orthodonit ApplianceGac Intl., Inc. · 1985
- 3 generations backK042178 Orthodontic Ceramic BracketsDentsply Intl. · 2004
- 2 generations backK082974 Mystique MB Ceramic BracketsDentsply Interntional · 2008
- 1 generation backK102803 Clarity Advanced Ceramic Brackets3M Unitek Corporation · 2011
- This deviceK131197 Edgewise Ceramic Brackets, Roth Ceramic BracketsDental Morelli · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K852179 | Ceramic Orthodonit Appliance | Gac Intl., Inc. | 1985 | — |
| −3 | K042178 | Orthodontic Ceramic Brackets | Dentsply Intl. | 2004 | — |
| −2 | K082974 | Mystique MB Ceramic Brackets | Dentsply Interntional | 2008 | — |
| −1 | K102803 | Clarity Advanced Ceramic Brackets | 3M Unitek Corporation | 2011 | — |
| 0 (this device) | K131197 | Edgewise Ceramic Brackets, Roth Ceramic Brackets | Dental Morelli | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 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? (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 |
|---|---|---|---|
| * | K102803 | Clarity Advanced Ceramic BracketsSummary page 1…Class II Product Code NJM Classification Panel Dental Regulation Numbers 21 CFR 872.5470 Substantial Equivalence K102803 Clarity Advanced Ceramic Brackets Description of Proposed Device Edgewise and Roth Ceramic Brackets are intended to be bonded t… | 2011 |
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 28 years and passes through 5 companies; a new generation was cleared every 4.2 years on median.
- None of the 7 ancestors has a recall.
- 6 other devices also cite its predicate K102803.
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?
Edgewise and Roth Ceramic Brackets are intended for use in orthodontic treatments. The brackets are affixed to teeth so that pressure can be exerted on the teeth.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131197 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131197: Edgewise Ceramic Brackets, Roth 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/K131197
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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