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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device dental barriers and sleeves
Regulation Description Surgical drape and drape accessories.
Definition Intended to serve as a disposable barrier for dental instruments to reduce the risk of cross contamination between dental patients.
Product CodePEM
Regulation Number 878.4370
Device Class 2


Premarket Reviews
ManufacturerDecision
FOMED INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
MINITUBE AB
  SUBSTANTIALLY EQUIVALENT 1
PREMIUM PLUS (DONGGUAN) LIMITED
  SUBSTANTIALLY EQUIVALENT 1
WELLMED DENTAL MEDICAL SUPPLY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
YONGQING HUAGUAN DENTAL INSTRUMENTS FACTORY
  SUBSTANTIALLY EQUIVALENT 1
YUEYING MEDICAL INSTRUMENTS (LANGFANG) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

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