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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device facial implant
Regulation Description Polytetrafluoroethylene with carbon fibers composite implant material.
Definition For use in plastic and reconstructive surgery. The devices can be used for cosmetic augmentation and corrections of soft tissue deformities in the face, including areas such as the nose, chin, and cheeks.
Product CodeODU
Regulation Number 878.3500
Device Class 2