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TPLC
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show TPLC since
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Device
block, bite
Product Code
JXL
Regulation Number
882.5070
Device Class
2
Premarket Reviews
Manufacturer
Decision
DUPACO INC.
SUBSTANTIALLY EQUIVALENT
1
MECTA CORPORATION
SUBSTANTIALLY EQUIVALENT
1
NEUROVICE, LLC
SUBSTANTIALLY EQUIVALENT
1
SURGOVATIONS LLC
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
3
3
2015
5
5
2017
1
1
2022
3
3
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
4
4
Adverse Event Without Identified Device or Use Problem
3
3
Appropriate Term/Code Not Available
2
2
Material Split, Cut or Torn
1
1
Crack
1
1
Insufficient Information
1
1
Material Integrity Problem
1
1
Material Separation
1
1
Detachment Of Device Component
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
4
4
Hypersensitivity/Allergic reaction
2
2
No Clinical Signs, Symptoms or Conditions
2
2
No Code Available
1
1
No Information
1
1
Skin Inflammation/ Irritation
1
1
Tooth Fracture
1
1
Skin Tears
1
1
No Consequences Or Impact To Patient
1
1
Airway Obstruction
1
1
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