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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device external cleaning solution
Definition For use on dental restorations, external to the mouth, prior to insertion into the mouth.
Product CodePME
Regulation Number 872.3260
Device Class 2


Premarket Reviews
ManufacturerDecision
BISCO, INC.
  SUBSTANTIALLY EQUIVALENT 1
KURARAY NORITAKE DENTAL INC.
  SUBSTANTIALLY EQUIVALENT 1

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