Device, Dental Sonography, For Monitoring Jaw Sounds
The Device, Dental Sonography, For Monitoring Jaw Sounds (product code NFQ) is a dental monitoring device that uses sonography to record and track jaw sounds over time, used for ongoing assessment of temporomandibular joint function rather than initial diagnosis. It is classified as an FDA Class 1 device within the Dental specialty, the lowest risk category, subject to general controls and exempt from 510(k) premarket notification. No specific regulation number has been assigned to this product code. The device is not flagged as an implant or life-sustaining device.
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Basic Information
- Product Code
- NFQ
- Device Class
- FDA class 1
- Regulation Number
- 872.2050
- Medical Specialty
- Dental
- Review Panel
- DE
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K970116 | ESG-1 ELECTROSONOGRAM (ESG-1) | Apr 02, 1997 | Substantially Equivalent | Myo-Tronics, Inc. |
| K905657 | SONOPAK/QS, SONOPAK | May 15, 1991 | Substantially Equivalent | Bioresearch |
| K905449 | ELECTROSONOGRAM ESG-1 | Apr 26, 1991 | Substantially Equivalent | Myo-Tronics, Inc. |
| K862286 | ARTHROPHONOMETER | Jan 07, 1987 | Substantially Equivalent | Arthrotek, Inc. |
FEI Numbers
This FDA classification entry is associated with 5 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 5 registration numbers. Click on an entry to view related FDA registrations.