FDA product code NJM: Bracket, Ceramic, Orthodontic
NJM is the FDA product code for bracket, ceramic, orthodontic. It is a Class II device, regulated under 21 CFR 872.5470 and reviewed by the Dental panel. FDA has cleared 60 510(k) submissions under NJM, 7 in the last five years, from 40 different applicants. The average 510(k) review took 111 days (median 90). FDA has posted 1 recall for NJM devices.
Definition
An orthodontic ceramic bracket is a device composed of ceramic, which is intended to be bonded to a tooth, upon which an orthodontic wire is used to move the tooth to a new position.
Classification
| Field | Value |
|---|---|
| Device name | Bracket, Ceramic, Orthodontic |
| Device class | Class II |
| Regulation | 21 CFR 872.5470 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for NJM
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 3 | 132 |
| 2018 | 4 | 79 |
| 2019 | 6 | 223 |
| 2020 | 2 | 101 |
| 2021 | 1 | 288 |
| 2022 | 2 | 30 |
| 2023 | 5 | 71 |
Compare with all 510(k) review times · Search every NJM clearance
Top NJM applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Lightforce Orthodontics | 3 | 2023-09-14 |
| American Orthodontics | 3 | 2023-07-07 |
| Biocetec Co., Ltd. | 3 | 2023-06-06 |
| Cdb Corporation | 3 | 2016-09-27 |
| Tomy, Inc. | 3 | 2016-08-26 |
35 more applicants have NJM clearances. See the full list in Caduvo.
Most recent NJM clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K232827 | Lightforce Orthodontics | LightForce Orthodontic System | 2023-09-14 | 1 |
| K232011 | American Orthodontics | Cleo | 2023-07-07 | 1 |
| K231635 | Biocetec Co., Ltd. | A-Line Advanced | 2023-06-06 | 1 |
| K230225 | Dyna Flex | DynaFlex Clear Brackets & Buttons | 2023-06-05 | 129 |
| K222847 | Orthometric - Industria E Comercio DE Produtos Medicos | Ceramic Brackets Orthometric | 2023-05-04 | 225 |
Recalls for NJM devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2013-11-19.
Frequently asked questions
What is FDA product code NJM?
NJM is the FDA product code for bracket, ceramic, orthodontic. It is a Class II device, regulated under 21 CFR 872.5470 and reviewed by the Dental panel.
What device class is NJM?
Class II, regulation 21 CFR 872.5470. Typical premarket route: 510(k).
How long does a 510(k) take for product code NJM?
Across 60 cleared submissions the average was 111 days from receipt to decision (median 90).
Which companies have the most NJM clearances?
Lightforce Orthodontics (3); American Orthodontics (3); Biocetec Co., Ltd. (3); Cdb Corporation (3); Tomy, Inc. (3).
Have NJM devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2013-11-19.
Next steps
- Run an FDA pathway report with predicate devices for product code NJM
- Run a recall and safety report across every NJM manufacturer
- Watch product code NJM for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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