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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device needle, dental
Regulation Description Dental injecting needle.
Product CodeDZM
Regulation Number 872.4730
Device Class 1


Premarket Reviews
ManufacturerDecision
KENDALL
  SUBSTANTIALLY EQUIVALENT 1
SPECIALIZED HEALTH PRODUCTS
  SUBSTANTIALLY EQUIVALENT 2
TERUMO CARDIOVASCULAR SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Slippage of device or device component 51
Break 43
Detachment of device component 41
Component(s), broken 14
Material puncture 3
Needle, separation 2
User used incorrect product for intended use 2
Detachment of device or device component 2
Device operates differently than expected 2
Use of Device Issue 2
Other (for use when an appropriate device code cannot be identified) 1
Unknown (for use when the device problem is not known) 1
Fracture 1
Loose 1
No Known Device Problem 1
Total Device Problems 167

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