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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device orthodontic vibratory accessory
Regulation Description Orthodontic plastic bracket.
Definition An orthodontic accessory intended for use during orthodontic treatment. It is used in conjunction with orthodontic appliances such as braces and helps facilitate minor anterior tooth movement.
Product CodeOYH
Regulation Number 872.5470
Device Class 2


Premarket Reviews
ManufacturerDecision
ORTHOACCEL TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
ORTHOACCEL TECHNOLOGY INC.
  SUBSTANTIALLY EQUIVALENT 1
PROPEL ORTHODONTICS LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Device Emits Odor 1 1
Overheating of Device 1 1
Melted 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1 1

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