• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Product Classification

  • Print
  • Share
  • E-mail
-
New Search Back to Search Results
Device mandibular condyle prosthesis
Regulation Description Mandibular condyle prosthesis.
Definition PMA to be filed by 3/30/99 (63 FR 71746 (12/30/98))
Regulation Medical Specialty Dental
Review Panel Dental
Product CodeMPL
Premarket Review Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1)
Dental Devices (DHT1B)
Submission Type PMA
Regulation Number 872.3960
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Eligible
Implanted Device? Yes
Life-Sustain/Support Device? No
Recognized Consensus Standards
Third Party Review Not Third Party Eligible
-
-