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U.S. Department of Health and Human Services

Product Classification

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Device orthodontic software
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 Division of Dental and ENT Devices (DHT1B)
Division of Dental and ENT Devices (DHT1B)
Submission Type 510(k)
Regulation Number 872.5470
Device Class 2
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
Accredited Persons
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