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TPLC
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show TPLC since
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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
FOREST DENTAL PRODUCTS, INC.
SUBSTANTIALLY EQUIVALENT
1
FOSHAN SAFETY MEDICAL EQUIPMENT CO., LTD
SUBSTANTIALLY EQUIVALENT
1
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
OSSTEM IMPLANT CO., LTD. CHAIR BUSINESS
SUBSTANTIALLY EQUIVALENT
1
OSSTEM IMPLANT CO.,LTD.
SUBSTANTIALLY EQUIVALENT
1
PELTON & CRANE
SUBSTANTIALLY EQUIVALENT
1
SHINHUNG COMPANY LTD
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2017
64
222
2018
73
256
2019
68
196
2020
48
131
2021
48
121
2022
44
131
2023
53
135
2024
43
135
Device Problems
MDRs with this Device Problem
Events in those MDRs
Overheating of Device
167
727
Detachment of Device or Device Component
74
221
Device Remains Activated
46
71
Unintended Power Up
41
60
Fracture
25
67
Fluid/Blood Leak
18
35
Disassembly
16
39
Break
9
11
Material Disintegration
8
14
Leak/Splash
6
9
Unintended Ejection
6
9
Smoking
5
5
Defective Device
3
3
Material Fragmentation
3
5
Adverse Event Without Identified Device or Use Problem
2
2
Metal Shedding Debris
2
2
Device Displays Incorrect Message
2
24
Retraction Problem
1
1
Cut In Material
1
1
Vibration
1
1
Manufacturing, Packaging or Shipping Problem
1
1
Defective Component
1
1
Failure to Power Up
1
1
Corroded
1
6
Mechanical Jam
1
1
No Device Output
1
1
Detachment Of Device Component
1
1
Peeled/Delaminated
1
1
Device Alarm System
1
1
Device Markings/Labelling Problem
1
16
Unintended Movement
1
1
Insufficient Information
1
1
Ejection Problem
1
1
Fail-Safe Problem
1
1
Inappropriate or Unexpected Reset
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
215
639
No Patient Involvement
147
406
Burn(s)
45
235
No Known Impact Or Consequence To Patient
42
153
No Consequences Or Impact To Patient
32
127
Insufficient Information
19
111
Burn, Thermal
7
73
Superficial (First Degree) Burn
5
46
No Information
4
12
Partial thickness (Second Degree) Burn
3
3
Full thickness (Third Degree) Burn
3
3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
Foreign Body In Patient
1
1
Laceration(s)
1
1
Reaction
1
1
Anaphylactic Shock
1
1
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