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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 51
No Known Device Problem 2
Defective item 2
Patient-device incompatibility 2
Device operates differently than expected 1
Malposition of device 1
Collapse 1
Size incorrect for patient 1
Improper or incorrect procedure or method 1
Structural problem 1
No Information 1
Device handling issue 1
Total Device Problems 65

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