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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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New Search show TPLC since Back to Search Results
Device cleanser, root canal
Product CodeKJJ
Device Class Unclassified


Premarket Reviews
ManufacturerDecision
BELPORT COMPANY, INC., GINGI-PAK
  SUBSTANTIALLY EQUIVALENT 1
EPIEN MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
INTER-MED / VISTA DENTAL
  SUBSTANTIALLY EQUIVALENT 1
INTER-MED, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2023 2 2
2025 2 2
2026 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Malposition of Device 3 3
Insufficient Information 1 1
Device Handling Problem 1 1
Patient-Device Incompatibility 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 4 4
Ecchymosis 3 3
Infiltration into Tissue 3 3
Hypersensitivity/Allergic reaction 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Skin Inflammation/ Irritation 1 1
Insufficient Information 1 1
Unspecified Tissue Injury 1 1

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