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TPLC - Total Product Life Cycle

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Device dental abutment design software for dental laboratory
Regulation Description Endosseous dental implant abutment.
Definition The device is intended to aid in the restoration of chewing function by allowing a dental laboratory or dental clinician to design the patient-specific component of a dental abutment (i.e. abutment collar and abutment post) and CAM or create that component at a dental office or dental laboratory following the directions of the dental implant system. The abutment-to-implant interface/connection platform is not a patient-specific component of the dental abutment.
Product CodePNP
Regulation Number 872.3630
Device Class 2