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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
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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