FDA product code NFQ: Device, Dental Sonography, For Monitoring Jaw Sounds
NFQ is the FDA product code for device, dental sonography, for monitoring jaw sounds. It is a Class I device, regulated under 21 CFR 872.2050 and reviewed by the Dental panel. FDA has cleared 4 510(k) submissions under NFQ, from 3 different applicants. The average 510(k) review took 144 days (median 146).
Classification
| Field | Value |
|---|---|
| Device name | Device, Dental Sonography, For Monitoring Jaw Sounds |
| Device class | Class I |
| Regulation | 21 CFR 872.2050 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every NFQ clearance
Top NFQ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Myo-Tronics, Inc. | 2 | 1997-04-02 |
| Bioresearch | 1 | 1991-05-15 |
| Arthrotek, Inc. | 1 | 1987-01-07 |
Most recent NFQ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K970116 | Myo-Tronics, Inc. | ESG-1 ELECTROSONOGRAM (ESG-1) | 1997-04-02 | 79 |
| K905657 | Bioresearch | SONOPAK/QS, SONOPAK | 1991-05-15 | 149 |
| K905449 | Myo-Tronics, Inc. | ELECTROSONOGRAM ESG-1 | 1991-04-26 | 142 |
| K862286 | Arthrotek, Inc. | ARTHROPHONOMETER | 1987-01-07 | 205 |
Recalls for NFQ devices
openFDA lists no recalls for product code NFQ.
Frequently asked questions
What is FDA product code NFQ?
NFQ is the FDA product code for device, dental sonography, for monitoring jaw sounds. It is a Class I device, regulated under 21 CFR 872.2050 and reviewed by the Dental panel.
What device class is NFQ?
Class I, regulation 21 CFR 872.2050. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code NFQ?
Across 4 cleared submissions the average was 144 days from receipt to decision (median 146).
Which companies have the most NFQ clearances?
Myo-Tronics, Inc. (2); Bioresearch (1); Arthrotek, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code NFQ
- Run a recall and safety report across every NFQ manufacturer
- Watch product code NFQ 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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