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TPLC - Total Product Life Cycle
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TPLC
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show TPLC since
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2024
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Device
instrument, diamond, dental
Product Code
DZP
Regulation Number
872.4535
Device Class
1
Premarket Reviews
Manufacturer
Decision
BEAVERS DENTAL, DIV. SYBRON CANADA, LTD.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2015
1
1
2016
1
1
2018
3
3
2019
1
1
2020
1
1
2021
6
6
2022
4
4
2023
5
5
2024
3
3
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
9
9
Material Twisted/Bent
7
7
Unintended Movement
4
4
Unintended Ejection
4
4
Detachment of Device or Device Component
4
4
Device Damaged by Another Device
3
3
Entrapment of Device
2
2
Insufficient Information
1
1
Vibration
1
1
Adverse Event Without Identified Device or Use Problem
1
1
Device Operates Differently Than Expected
1
1
Device Dislodged or Dislocated
1
1
Temperature Problem
1
1
Inadequacy of Device Shape and/or Size
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Tooth Fracture
6
6
No Clinical Signs, Symptoms or Conditions
5
5
Insufficient Information
4
4
Foreign Body In Patient
3
3
Pain
3
3
Laceration(s)
3
3
Device Embedded In Tissue or Plaque
3
3
Burn(s)
1
1
Injury
1
1
Swelling
1
1
Scar Tissue
1
1
Hemorrhage/Bleeding
1
1
Bruise/Contusion
1
1
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