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U.S. Department of Health and Human Services

Product Classification

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Device device, jaw tracking, for diagnosis of tmj/mpd disorders
Regulation Description Jaw tracking device.
Regulation Medical Specialty Dental
Review Panel Dental
Product CodeNFR
Premarket Review Office of Device Evaluation (ODE)
Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices (DAGRID)
Dental Devices Branch (DEDB)
Submission Type 510(k)
Regulation Number 872.2060
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Guidance Document
  • Class II Special Controls Guidance Document: Dental Sonography and Jaw Tracking Devices - Guidance for Industry and FDA Staff
Third Party Review Not Third Party Eligible
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