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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device block, bite
Regulation Description Bite block.
Product CodeJXL
Regulation Number 882.5070
Device Class 2


Premarket Reviews
ManufacturerDecision
ETHOX INTERNATIONAL
  SUBSTANTIALLY EQUIVALENT 1
SOMATICS, INC.
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Break 6
No Known Device Problem 3
No code available 2
Material separation 2
Other (for use when an appropriate device code cannot be identified) 1
Detachment of device or device component 1
Component(s), broken 1
Total Device Problems 16

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