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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
Definition For the fabrication of preformed denture teeth for use in a denture base
Product CodePZY
Regulation Number 872.3590
Device Class 2


Premarket Reviews
ManufacturerDecision
DENTCA, INC.
  SUBSTANTIALLY EQUIVALENT 1

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