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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device additively manufactured, preformed, resin denture tooth
Regulation Description Preformed plastic denture tooth.
Definition For the fabrication of preformed denture teeth for use in a denture base
Product CodePZY
Regulation Number 872.3590
Device Class 2

MDR Year MDR Reports MDR Events
2026 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
Hypersensitivity/Allergic reaction 1 1

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