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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device syringe, periodontic, endodontic, irrigating
Regulation Description Dental hand instrument.
Product CodeEIC
Regulation Number 872.4565
Device Class 1


Premarket Reviews
ManufacturerDecision
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Break 6
Component falling 1
Crack 1
Overfill 1
Total Device Problems 9

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