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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device aligner, bracket, orthodontic
Product CodeECQ
Regulation Number 872.4565
Device Class 1

MDR Year MDR Reports MDR Events
2018 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Patient-Device Incompatibility 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Dysphagia/ Odynophagia 1 1
Swelling 1 1
Burning Sensation 1 1
Tingling 1 1

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