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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
Device handpiece, belt and/or gear driven, dental
Product CodeEFA
Regulation Number 872.4200
Device Class 1


Premarket Reviews
ManufacturerDecision
KALTENBACH & VOIGT GMBH
  SUBSTANTIALLY EQUIVALENT 1
MICRO-NX CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2017 2 2
2018 97 97
2019 59 59
2020 2 57
2022 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Overheating of Device 155 210
Use of Device Problem 7 7
Detachment Of Device Component 2 2
Insufficient Information 2 2
Loose or Intermittent Connection 1 1
Improper or Incorrect Procedure or Method 1 1
Detachment of Device or Device Component 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 121 121
Burn(s) 34 89
Burn, Thermal 10 10
No Known Impact Or Consequence To Patient 6 6
No Information 5 5
No Clinical Signs, Symptoms or Conditions 2 57
Injury 1 1

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