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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 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 3
BEIJING C-ROOT DENTAL MEDICAL DEVICES CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
DIADENT GROUP INTERNATIONAL
  SUBSTANTIALLY EQUIVALENT 6
ENPUNO BIOTECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
ESSENTIAL DENTAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
GENOSS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
INNOVATIVE BIOCERAMIX INC.
  SUBSTANTIALLY EQUIVALENT 1
INNOVATIVE BIOCERAMIX, INC.
  SUBSTANTIALLY EQUIVALENT 1
INTER-MED, INC.
  SUBSTANTIALLY EQUIVALENT 1
LUMENDO AG
  SUBSTANTIALLY EQUIVALENT 1
MARUCHI
  SUBSTANTIALLY EQUIVALENT 3
MEDICLUS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
META BIOMED CO., LTD.
  SUBSTANTIALLY EQUIVALENT 6
NUSMILE, LTD.
  SUBSTANTIALLY EQUIVALENT 1
PREVEST DENPRO LIMITED
  SUBSTANTIALLY EQUIVALENT 1
SEPTODONT
  SUBSTANTIALLY EQUIVALENT 2
SONENDO, INC.
  SUBSTANTIALLY EQUIVALENT 1
SPRIG ORAL HEALTH TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
ULTRADENT PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 6 6
2020 3 3
2021 9 11
2022 10 10
2023 7 7
2024 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Patient-Device Incompatibility 17 19
Adverse Event Without Identified Device or Use Problem 14 16
Patient Device Interaction Problem 5 5
Overfill 4 4
Material Too Soft/Flexible 3 3
Component Misassembled 2 2
Excess Flow or Over-Infusion 2 2
Material Integrity Problem 2 2
Material Protrusion/Extrusion 2 2
Manufacturing, Packaging or Shipping Problem 1 1
Component Missing 1 1
Failure to Align 1 1
Packaging Problem 1 1
Appropriate Term/Code Not Available 1 1
Loss of or Failure to Bond 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Hypersensitivity/Allergic reaction 15 15
Pain 10 12
Swelling/ Edema 5 5
No Consequences Or Impact To Patient 3 3
Unspecified Infection 3 3
Abscess 3 3
Discomfort 2 2
Rash 2 2
Insufficient Information 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Numbness 2 2
No Known Impact Or Consequence To Patient 2 2
No Information 1 1
No Code Available 1 1
Caustic/Chemical Burns 1 1
Tissue Breakdown 1 3
Increased Sensitivity 1 1
Tinnitus 1 1
Osteolysis 1 1
Reaction 1 1
Erythema 1 1
Fistula 1 1
Granuloma 1 1
Inflammation 1 1
Necrosis 1 3

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