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TPLC
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show TPLC since
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2024
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Device
unit, operative dental
Product Code
EIA
Regulation Number
872.6640
Device Class
1
Premarket Reviews
Manufacturer
Decision
A-DEC, INC.
SUBSTANTIALLY EQUIVALENT
1
AIOBIO CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
FOSHAN SAFETY MEDICAL EQUIPMENT CO., LTD
SUBSTANTIALLY EQUIVALENT
1
1. K231845
Dental unit Model: Mare
LARES RESEARCH
SUBSTANTIALLY EQUIVALENT
1
MEGAGEN IMPLANT CO., LTD.
SUBSTANTIALLY EQUIVALENT
2
MGNEWTON LTD.
SUBSTANTIALLY EQUIVALENT
1
OLSEN INDUSTRIA E COMERCIO S.A.
SUBSTANTIALLY EQUIVALENT
1
OLSEN INDÚSTRIA E COMÉRCIO S.A.
SUBSTANTIALLY EQUIVALENT
1
OSSTEM IMPLANT CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
SHINHUNG COMPANY LTD
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2019
68
196
2020
48
131
2021
48
121
2022
44
131
2023
53
135
2024
9
37
Device Problems
MDRs with this Device Problem
Events in those MDRs
Overheating of Device
102
407
Detachment of Device or Device Component
61
162
Unintended Power Up
26
33
Device Remains Activated
23
31
Fracture
20
57
Fluid/Blood Leak
14
28
Material Disintegration
6
12
Break
5
7
Unintended Ejection
3
4
Defective Device
3
3
Smoking
2
2
Vibration
1
1
Retraction Problem
1
1
Failure to Power Up
1
1
Corroded
1
6
Device Alarm System
1
1
Material Fragmentation
1
1
Fail-Safe Problem
1
1
Inappropriate or Unexpected Reset
1
1
Manufacturing, Packaging or Shipping Problem
1
1
Mechanical Jam
1
1
Adverse Event Without Identified Device or Use Problem
1
1
Insufficient Information
1
1
Ejection Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
183
543
No Patient Involvement
69
173
Burn(s)
32
144
No Consequences Or Impact To Patient
17
93
No Known Impact Or Consequence To Patient
12
38
Insufficient Information
12
61
Burn, Thermal
3
33
Superficial (First Degree) Burn
2
2
Partial thickness (Second Degree) Burn
2
2
Full thickness (Third Degree) Burn
2
2
No Information
2
8
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
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