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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 3
ALLESEE ORTHODONTIC APPLIANCES
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
No code available 90
Patient-device incompatibility 3
Device operates differently than expected 3
No Known Device Problem 3
No Information 2
Unexpected therapeutic results 2
Defective item 2
Malposition of device 1
Device handling issue 1
Improper or incorrect procedure or method 1
Structural problem 1
Collapse 1
Material frayed 1
Size incorrect for patient 1
Total Device Problems 112

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