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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device blade-form endosseous dental implant
Regulation Description Endosseous dental implant.
Definition Device made of a material such as titanium or titanium alloy, that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.
Product CodeNRQ
Regulation Number 872.3640
Device Class 2


Premarket Reviews
ManufacturerDecision
DEPUY INTL., LTD.
  SUBSTANTIALLY EQUIVALENT 1

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