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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device adhesive, bracket and tooth conditioner, resin
Product CodeDYH
Regulation Number 872.3750
Device Class 2


Premarket Reviews
ManufacturerDecision
3M UNITEK ORTHODONTIC PRODUCTS
  SUBSTANTIALLY EQUIVALENT 1
AMERICAN ORTHODONTICS
  SUBSTANTIALLY EQUIVALENT 1
DENTSCARE LTDA
  SUBSTANTIALLY EQUIVALENT 1
LARGENT HEALTH, LLC
  SUBSTANTIALLY EQUIVALENT 1
RELIANCE ORTHODONTIC PRODUCTS INC.
  SUBSTANTIALLY EQUIVALENT 1
TP ORTHODONTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
VOCO GMBH
  SUBSTANTIALLY EQUIVALENT 2

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