• 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 prosthesis, orthodontic
Definition Foreign dental lab manufactured orthodontic prosthesis are finished custom-fit orthodontic prosthesis.
Review Panel Dental
Product CodeNSR
Premarket Review Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1)
Division of Dental and ENT Devices (DHT1B)
Not Classified Reason Enforcement Discretion
Submission Type Enforcement Discretion
Device Class Not Classified
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Eligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
-
-