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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device impression material for fabrication of patient-matched mouthguards, over-the-counter
Regulation Description Impression material.
Definition An over-the-counter device that is intended to reproduce the structure of a patient's teeth and gums for the fabrication of patient-matched mouthguards/nightguards.
Product CodeSHI
Regulation Number 872.3660
Device Class 2


Premarket Reviews
ManufacturerDecision
ENCORE GUARDS
  SUBSTANTIALLY EQUIVALENT 1
GRINDGUARD, INC.
  SUBSTANTIALLY EQUIVALENT 1

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