• 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 othodontic software
Regulation Description Orthodontic plastic bracket.
Definition The device is software that is to be used for the diagnosis and treatment planning of orthodontic patients and conditions.It may include orthodontic output devices used for the treatment of orthodontics.The device is intended for prescription use only.
Physical State Software which may produce an orthodontic appliance
Technical Method May use software, scanning equipment, CAD/CAM, and printing machines for the fabrication of orthodontic appliances
Target Area Intraoral
Regulation Medical Specialty Dental
Review Panel Dental
Product CodePNN
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 872.5470
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
-
-