Product Code: NFS FDA class 1 21 CFR 872.2060

Device, Jaw Tracking, For Monitoring Jaw Positions

Dental

The Device, Jaw Tracking, For Monitoring Jaw Positions (product code NFS) is a dental monitoring device that tracks jaw position and movement on an ongoing basis to assess temporomandibular joint function, distinct from the diagnostic jaw tracking device. 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
2
FEI Numbers
16
Registration Numbers
16
Unique Applicants
2
Years Active
11

Research product code NFS in seconds

The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.

Free to try · every answer cites its records

Basic Information

Product Code
NFS
Device Class
FDA class 1
Regulation Number
872.2060
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

Loading...

Related 510(k) Clearances

This FDA classification is associated with 2 510(k) clearances via K numbers.

K Number Device Name
K952218 JT-3 ELECTROGNATHOGRAPH
K843951 SIROGNATHOGRAPH

FEI Numbers

This FDA classification entry is associated with 16 FEI numbers. Click on an entry to view related FDA registrations.

Registration Numbers

This FDA classification entry is associated with 16 registration numbers. Click on an entry to view related FDA registrations.