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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device tube, orthodontic
Product CodeDZD
Regulation Number 872.5410
Device Class 1

MDR Year MDR Reports MDR Events
2019 2 2
2020 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Structural Problem 3 3
Product Quality Problem 2 2
Inadequacy of Device Shape and/or Size 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
Therapeutic Effects, Unexpected 2 2
Complaint, Ill-Defined 2 2
No Clinical Signs, Symptoms or Conditions 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Ormco/Sybronendo II Feb-06-2020
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