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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device resin, root canal filling
Product CodeKIF
Regulation Number 872.3820
Device Class 2


Premarket Reviews
ManufacturerDecision
ANGELUS INDUSTRIA DE PRODUTOS ODONTOLOGICOS S/A
  SUBSTANTIALLY EQUIVALENT 5
BEIJING C-ROOT DENTAL MEDICAL DEVICES CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
DIADENT GROUP INTERNATIONAL
  SUBSTANTIALLY EQUIVALENT 6
ESSENTIAL DENTAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
INNOVATIVE BIOCERAMIX INC.
  SUBSTANTIALLY EQUIVALENT 1
INTER-MED, INC.
  SUBSTANTIALLY EQUIVALENT 1
ITENA CLINICAL
  SUBSTANTIALLY EQUIVALENT 1
MARUCHI
  SUBSTANTIALLY EQUIVALENT 4
META BIOMED CO., LTD.
  SUBSTANTIALLY EQUIVALENT 4
NUSMILE, LTD.
  SUBSTANTIALLY EQUIVALENT 1
  1.  K181917  MTA2.3 MATERIALS
PREVEST DENPRO LIMITED
  SUBSTANTIALLY EQUIVALENT 1
SEPTODONT
  SUBSTANTIALLY EQUIVALENT 3
SONENDO, INC.
  SUBSTANTIALLY EQUIVALENT 2
SPRIG ORAL HEALTH TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
TYDS BIOTECH INCORPORATION
  SUBSTANTIALLY EQUIVALENT 1
ULTRADENT PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
VERICOM CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 5 5
2018 13 13
2019 6 6
2020 3 3
2021 9 11
2022 10 10

Device Problems MDRs with this Device Problem Events in those MDRs
Patient-Device Incompatibility 13 15
Adverse Event Without Identified Device or Use Problem 10 12
Overfill 8 8
Appropriate Term/Code Not Available 6 6
Insufficient Information 4 4
Patient Device Interaction Problem 3 3
Component Misassembled 2 2
Component Missing 2 2
Excess Flow or Over-Infusion 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Material Integrity Problem 2 2
Material Protrusion/Extrusion 2 2
Device Misassembled During Manufacturing /Shipping 1 1
Extrusion 1 1
Improper or Incorrect Procedure or Method 1 1
Failure to Align 1 1
Packaging Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Hypersensitivity/Allergic reaction 10 10
Pain 9 11
No Consequences Or Impact To Patient 6 6
No Code Available 5 5
Swelling/ Edema 5 5
Missing Value Reason 4 4
Insufficient Information 2 2
Discomfort 2 2
Necrosis 2 4
No Known Impact Or Consequence To Patient 2 2
No Information 2 2
Undesired Nerve Stimulation 1 1
Injury 1 1
Reaction 1 1
Numbness 1 1
Tissue Breakdown 1 3
Rash 1 1
Increased Sensitivity 1 1
Swelling 1 1
Tingling 1 1
Unspecified Infection 1 1
Inflammation 1 1
Abscess 1 1
Erythema 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1

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