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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device retainer, matrix
Product CodeJEP
Regulation Number 872.4565
Device Class 1


Premarket Reviews
ManufacturerDecision
GARRISON DENTAL SOLUTIONS
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 1 1
2016 2 2
2023 8 8

Device Problems MDRs with this Device Problem Events in those MDRs
Patient-Device Incompatibility 2 2
Component or Accessory Incompatibility 1 1
Material Protrusion/Extrusion 1 1
Insufficient Information 1 1
Product Quality Problem 1 1
Inadequacy of Device Shape and/or Size 1 1
Use of Device Problem 1 1
Improper or Incorrect Procedure or Method 1 1
Obstruction of Flow 1 1
Defective Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Physical Asymmetry 2 2
Apnea 1 1
Dyspnea 1 1
Headache 1 1
Hemorrhage/Bleeding 1 1
Failure of Implant 1 1
Anxiety 1 1
Injury 1 1
Osteolysis 1 1
Sensitivity of Teeth 1 1
Tooth Fracture 1 1
No Known Impact Or Consequence To Patient 1 1
Partial thickness (Second Degree) Burn 1 1
Difficulty Chewing 1 1
Malunion of Bone 1 1
Unspecified Tissue Injury 1 1

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