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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device floss, dental
Regulation Description Dental floss.
Product CodeJES
Regulation Number 872.6390
Device Class 1


Premarket Reviews
ManufacturerDecision
  SUBSTANTIALLY EQUIVALENT 1
JOHN O. BUTLER CO.
  SUBSTANTIALLY EQUIVALENT 1
JOHNSON & JOHNSON
  SUBSTANTIALLY EQUIVALENT 2
PROCTER & GAMBLE CO.
  SUBSTANTIALLY EQUIVALENT 1
ULTRADENT PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Break 37
No Known Device Problem 14
Unknown (for use when the device problem is not known) 5
No code available 2
No Information 1
Malfunction 1
Battery issue 1
Dislodged or dislocated 1
Disconnection 1
Material frayed 1
Other (for use when an appropriate device code cannot be identified) 1
Total Device Problems 65

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