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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device instrument, hand, calculus removal
Regulation Description Dental hand instrument.
Product CodeELA
Regulation Number 872.4565
Device Class 1


Premarket Reviews
ManufacturerDecision
ELA MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
MILTEX
  SUBSTANTIALLY EQUIVALENT 1

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