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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device clamp, wire, orthodontic
Product CodeECN
Regulation Number 872.5410
Device Class 1

MDR Year MDR Reports MDR Events
2015 2 2
2017 1 1
2018 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Break 2 2
Device Or Device Fragments Location Unknown 1 1
Detachment of Device or Device Component 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Foreign Body In Patient 2 2
Device Embedded In Tissue or Plaque 2 2

Recalls
Manufacturer Recall Class Date Posted
1 Specialty Appliance Works, Inc. II Apr-22-2015
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