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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device burnisher, operative
Regulation Description Dental hand instrument.
Product CodeEKJ
Regulation Number 872.4565
Device Class 1


Premarket Reviews
ManufacturerDecision
3M COMPANY
  SUBSTANTIALLY EQUIVALENT 1
ADVANCE MEDICAL DESIGNS, INC.
  SUBSTANTIALLY EQUIVALENT 1
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 1
COLLAGEN
  SUBSTANTIALLY EQUIVALENT 1
HU-FRIEDY
  SUBSTANTIALLY EQUIVALENT 1
MEDTROL, INC.
  SUBSTANTIALLY EQUIVALENT 1
SPECIALIZED HEALTH PRODUCTS
  SUBSTANTIALLY EQUIVALENT 1

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