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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device aligner, sequential
Regulation Description Orthodontic plastic bracket.
Definition The device moves the teeth by continuous gentle force for treatment of minor tooth malocclusion.
Product CodeNXC
Regulation Number 872.5470
Device Class 2


Premarket Reviews
ManufacturerDecision
ALIGN TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 2
ALLESEE ORTHODONTIC APPLIANCES
  SUBSTANTIALLY EQUIVALENT 2

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