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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device handpiece, belt and/or gear driven, dental
Product CodeEFA
Regulation Number 872.4200
Device Class 1


Premarket Reviews
ManufacturerDecision
ANTHOGYR
  SUBSTANTIALLY EQUIVALENT 2
DPM USA CORP.
  SUBSTANTIALLY EQUIVALENT 1
KALTENBACH & VOIGT GMBH
  SUBSTANTIALLY EQUIVALENT 2
KALTENBACH & VOIGT GMBH & CO.
  SUBSTANTIALLY EQUIVALENT 1
MICRO-NX CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
REDENT NOVA LTD
  SUBSTANTIALLY EQUIVALENT 1
SAESHIN PRECISION CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2016 1 1
2017 2 2
2018 97 97
2019 59 59
2020 2 57
2022 4 4
2023 3 3
2024 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Overheating of Device 160 215
Use of Device Problem 8 8
Detachment Of Device Component 2 2
Detachment of Device or Device Component 2 2
Insufficient Information 2 2
Physical Resistance/Sticking 2 2
Loose or Intermittent Connection 1 1
Improper or Incorrect Procedure or Method 1 1
Dent in Material 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 121 121
Burn(s) 38 93
Burn, Thermal 10 10
No Known Impact Or Consequence To Patient 6 6
No Information 5 5
No Clinical Signs, Symptoms or Conditions 3 58
Foreign Body In Patient 1 1
Injury 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Dental EZ Group Star Dental Division II Jul-17-2014
2 Dental EZ Stardental Division III Sep-02-2010
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