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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device denture, plastic, teeth
Regulation Description Preformed plastic denture tooth.
Product CodeELM
Regulation Number 872.3590
Device Class 2

MDR Year MDR Reports MDR Events
2017 1 1
2018 1 1
2020 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Loose or Intermittent Connection 1 1
Inadequacy of Device Shape and/or Size 1 1
Device Contamination with Chemical or Other Material 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Crack 1 1
Patient-Device Incompatibility 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Hypersensitivity/Allergic reaction 1 1
Laceration(s) 1 1
Complaint, Ill-Defined 1 1
No Code Available 1 1

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