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U.S. Department of Health and Human Services

Product Classification

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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.
Physical State Solid implants
Technical Method Plastic surgery
Target Area face
Regulation Medical Specialty General & Plastic Surgery
Review Panel General & Plastic Surgery
Product CodeODU
Premarket Review Office of Device Evaluation (ODE)
Division of Surgical Devices (DSD)
Plastic and Reconstructive Surgery Devices Branch One - Implants and Tools (PRSB1)
Submission Type 510(k)
Regulation Number 878.3500
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review Not Third Party Eligible
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