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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device bracket, plastic, orthodontic
Product CodeDYW
Regulation Number 872.5470
Device Class 2


Premarket Reviews
ManufacturerDecision
BLUE SKY BIO
  SUBSTANTIALLY EQUIVALENT 1
BRACES ON DEMAND, INC
  SUBSTANTIALLY EQUIVALENT 1
TOMY, INC.
  SUBSTANTIALLY EQUIVALENT 1

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