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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
Device headgear, extraoral, orthodontic
Product CodeDZB
Regulation Number 872.5500
Device Class 2


Premarket Reviews
ManufacturerDecision
ITA.O ITALIAN ORTHODONTIC SYSTEM S.R.L.
  SUBSTANTIALLY EQUIVALENT 1
SAWBROS INDUSTRIES PVT.LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 1 1
2018 1 1
2021 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Patient-Device Incompatibility 1 1
Device Markings/Labelling Problem 1 1
Adverse Event Without Identified Device or Use Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Hypersensitivity/Allergic reaction 1 1
Complaint, Ill-Defined 1 1
Insufficient Information 1 1

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