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TPLC - Total Product Life Cycle
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Device dental abutment design software for dental laboratory
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


Premarket Reviews
ManufacturerDecision
3SHAPE A/S
  SUBSTANTIALLY EQUIVALENT 1
DENTSPLY SIRONA
  SUBSTANTIALLY EQUIVALENT 1
EXOCAD GMBH
  SUBSTANTIALLY EQUIVALENT 1
NOBEL BIOCARE AB
  SUBSTANTIALLY EQUIVALENT 1
PRISMATIK DENTALCRAFT, INC.
  SUBSTANTIALLY EQUIVALENT 1
RGORITHM KOREA
  SUBSTANTIALLY EQUIVALENT 1

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