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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device orthodontic led accessory
Definition Intended for use during orthodontic treatment. It is used in conjunction with brackets and wires or aligners and helps facilitate minor anterior tooth movement.
Product CodePLH
Regulation Number 872.5470
Device Class 2


Premarket Reviews
ManufacturerDecision
BIOLUX TECHNOLOGY GMBH
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Unspecified Infection 1 1

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