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TPLC - Total Product Life Cycle
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TPLC
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Device
handpiece, belt and/or gear driven, dental
Product Code
EFA
Regulation Number
872.4200
Device Class
1
Premarket Reviews
Manufacturer
Decision
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
1
1
Device Problems
MDRs with this Device Problem
Events in those MDRs
Overheating of Device
160
215
Use of Device Problem
7
7
Detachment Of 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
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)
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
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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