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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
EPIEN MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
INTER-MED / VISTA DENTAL
  SUBSTANTIALLY EQUIVALENT 1
INTER-MED, INC.
  SUBSTANTIALLY EQUIVALENT 1
INTER-MED/ VISTA DENTAL PRODUCTS
  SUBSTANTIALLY EQUIVALENT 1
INTER-MED/VISTA DENTAL PRODUCTS
  SUBSTANTIALLY EQUIVALENT 1
PAC-DENT, INC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 1 1
2020 1 1
2023 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 1 1
Contamination /Decontamination Problem 1 1
Migration 1 1
Improper or Incorrect Procedure or Method 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Hypersensitivity/Allergic reaction 1 1
Skin Inflammation/ Irritation 1 1
No Known Impact Or Consequence To Patient 1 1
No Patient Involvement 1 1
Pain 1 1
Unspecified Tissue Injury 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Inter-Med Llc II Oct-01-2019
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