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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device block, bite
Product CodeJXL
Regulation Number 882.5070
Device Class 2


Premarket Reviews
ManufacturerDecision
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
Insufficient Information 1 1
Detachment Of Device Component 1 1
Crack 1 1
Material Separation 1 1
Material Integrity Problem 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
Airway Obstruction 1 1
No Consequences Or Impact To Patient 1 1
Tooth Fracture 1 1
Skin Tears 1 1
No Information 1 1
No Code Available 1 1
Skin Inflammation/ Irritation 1 1

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