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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


Premarket Reviews
ManufacturerDecision
IVOCLAR VIVADENT, INC.
  SUBSTANTIALLY EQUIVALENT 4
KULZER
  SUBSTANTIALLY EQUIVALENT 3

Device Problems
Material separation 36
Use of Device Issue 26
No Known Device Problem 5
Patient-device incompatibility 4
Failure to obtain samples 2
Total Device Problems 73

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