Device, Jaw Tracking, For Monitoring Jaw Positions
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.
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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
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
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.