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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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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.
Product CodePNN
Regulation Number 872.5470
Device Class 2