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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device alloy, gold-based noble metal
Regulation Description Noble metal alloy.
Product CodeEJT
Regulation Number 872.3060
Device Class 2


Premarket Reviews
ManufacturerDecision
BENTLEY LABORATORIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
DENTSPLY TULSA DENTAL SPECIALTIES
  SUBSTANTIALLY EQUIVALENT 5
IVOCLAR VIVADENT, INC.
  SUBSTANTIALLY EQUIVALENT 7
KODENT, INC.
  SUBSTANTIALLY EQUIVALENT 1
KULZER
  SUBSTANTIALLY EQUIVALENT 2
ORMCO CORP.
  SUBSTANTIALLY EQUIVALENT 1
STERNGOLD
  SUBSTANTIALLY EQUIVALENT 3

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