Product Code: NFQ FDA class 1 21 CFR 872.2050

Device, Dental Sonography, For Monitoring Jaw Sounds

Dental

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.

510(k)s
4
FEI Numbers
5
Registration Numbers
5
Unique Applicants
3
Years Active
10

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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

GMP Exempt
Implant
Life Sustain/Support
Third Party
Summary Malfunction Reporting

510(k) Clearance History

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Related 510(k) Clearances

This FDA classification is associated with 4 510(k) clearances via K numbers.

K Number Device Name
K970116 ESG-1 ELECTROSONOGRAM (ESG-1)
K905657 SONOPAK/QS, SONOPAK
K905449 ELECTROSONOGRAM ESG-1
K862286 ARTHROPHONOMETER

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.