510(k) · Cleared
ClearedCeramic Bracket
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mem Dental Technology Co., Ltd. · NJM Bracket, Ceramic, Orthodontic
Cleared on Jun 7, 2019 as substantially equivalent to K160615 (Tomy, Inc., 2016) after a 422-day review. Its family tree reaches back 5 generations to 1985.
- Decided
- Jun 7, 2019
- Review
- 422 days
- Class
- Class II
- Product code
- NJM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K852179 (1985). 10 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK852179 Ceramic Orthodonit ApplianceGac Intl., Inc. · 1985
- 4 generations backK042178 Orthodontic Ceramic BracketsDentsply Intl. · 2004
- 3 generations backK082974 Mystique MB Ceramic BracketsDentsply Interntional · 2008
- 2 generations backK102803 Clarity Advanced Ceramic Brackets3M Unitek Corporation · 2011
- 1 generation backK160615 Orthodontic Ceramic Brackets 1.1Tomy, Inc. · 2016
- This deviceK180952 Ceramic BracketMem Dental Technology Co., Ltd. · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K852179 | Ceramic Orthodonit Appliance | Gac Intl., Inc. | 1985 | — |
| −4 | K042178 | Orthodontic Ceramic Brackets | Dentsply Intl. | 2004 | — |
| −3 | K082974 | Mystique MB Ceramic Brackets | Dentsply Interntional | 2008 | — |
| −2 | K102803 | Clarity Advanced Ceramic Brackets | 3M Unitek Corporation | 2011 | — |
| −1 | K160615 | Orthodontic Ceramic Brackets 1.1 | Tomy, Inc. | 2016 | — |
| 0 (this device) | K180952 | Ceramic Bracket | Mem Dental Technology Co., Ltd. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 2006 | 2 | 0 |
| 2012 | 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 |
|---|---|---|---|
| * | K160615 | Orthodontic Ceramic Brackets 1.1Summary page 4…ion CFR Part 872.5470 Device Class II Classification Panel Dental 3 Primary Predicate 510(k) number K160615 Section 5. 510(k) Summary 1 /5 MEM Dental T… | 2016 |
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 34 years and passes through 6 companies; a new generation was cleared every 4.2 years on median.
- None of the 10 ancestors has a recall.
- 1 other device also cites its predicate K160615.
How does its category compare?
All NJM devicesNJM Bracket, Ceramic, Orthodontic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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?
Ceramic Bracket is indicated for orthodontic movement of natural teeth.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K180952 · printed Nov 4, 2026
Cite this page
510(k) Report. “K180952: Ceramic Bracket.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K180952
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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