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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 PRODUCTOS ODONTOLOGICOS
  SUBSTANTIALLY EQUIVALENT 2
ANGELUS INDUSTRIA DE PRODUCTOS ODONTOLOGICOS SA
  SUBSTANTIALLY EQUIVALENT 1
ANGELUS INDUSTRIA DE PRODUTOS ODONTOLOGICOS S/A
  SUBSTANTIALLY EQUIVALENT 5
AVALON BIOMED INC.
  SUBSTANTIALLY EQUIVALENT 3
BEIJING C-ROOT DENTAL MEDICAL DEVICES CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
BIOMTA
  SUBSTANTIALLY EQUIVALENT 1
DENTSPLY INTERNATIONAL INC.
  SUBSTANTIALLY EQUIVALENT 1
DIADENT GROUP INTERNATIONAL
  SUBSTANTIALLY EQUIVALENT 6
DISCUS DENTAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
DO CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
DRFP LTD
  SUBSTANTIALLY EQUIVALENT 1
DRFP LTD.
  SUBSTANTIALLY EQUIVALENT 1
ESSENTIAL DENTAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
GENOSS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
INNOVATIVE BIOCERAMIX INC.
  SUBSTANTIALLY EQUIVALENT 5
INNOVATIVE BIOCERAMIX, INC.
  SUBSTANTIALLY EQUIVALENT 1
INTER-MED, INC.
  SUBSTANTIALLY EQUIVALENT 1
ITENA CLINICAL
  SUBSTANTIALLY EQUIVALENT 1
KERR CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
KM CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
LUMENDO AG
  SUBSTANTIALLY EQUIVALENT 1
MARUCHI
  SUBSTANTIALLY EQUIVALENT 7
MEDICLUS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
META BIOMED CO., LTD.
  SUBSTANTIALLY EQUIVALENT 6
MICRO-MEGA SOCIETE ANONYME
  SUBSTANTIALLY EQUIVALENT 1
NOVOCOL, INC.
  SUBSTANTIALLY EQUIVALENT 1
NUSMILE, LTD.
  SUBSTANTIALLY EQUIVALENT 1
PAXMED INTERNATIONAL
  SUBSTANTIALLY EQUIVALENT 1
PREVEST DENPRO LIMITED
  SUBSTANTIALLY EQUIVALENT 1
S & C POLYMER GMBH
  SUBSTANTIALLY EQUIVALENT 1
S&C POLYMER SILICON- UND COMPOSITE SPEZIALITAETEN
  SUBSTANTIALLY EQUIVALENT 1
SEPTODONT
  SUBSTANTIALLY EQUIVALENT 5
SONENDO, INC.
  SUBSTANTIALLY EQUIVALENT 2
SPRIG ORAL HEALTH TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
SYBRON DENTAL SPECIALTIES
  SUBSTANTIALLY EQUIVALENT 3
TYDS BIOTECH INCORPORATION
  SUBSTANTIALLY EQUIVALENT 1
ULTRADENT PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
VERICOM CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2014 421 421
2015 15 15
2016 5 5
2017 5 5
2018 13 13
2019 6 6
2020 3 3
2021 9 11
2022 10 10
2023 7 7
2024 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 167 167
Device Operates Differently Than Expected 122 122
Adverse Event Without Identified Device or Use Problem 115 117
Material Disintegration 32 32
Patient-Device Incompatibility 28 30
Loss of or Failure to Bond 24 24
Material Integrity Problem 20 20
Overfill 14 14
Appropriate Term/Code Not Available 9 9
Failure To Adhere Or Bond 8 8
Patient Device Interaction Problem 4 4
Material Too Soft/Flexible 3 3
Degraded 3 3
Excess Flow or Over-Infusion 2 2
Component Missing 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Component Misassembled 2 2
Material Protrusion/Extrusion 2 2
Packaging Problem 1 1
Failure to Align 1 1
Device Misassembled During Manufacturing /Shipping 1 1
Extrusion 1 1
Device Contamination with Chemical or Other Material 1 1
Loss of Threshold 1 1
Vibration 1 1
Improper or Incorrect Procedure or Method 1 1
Material Discolored 1 1
Break 1 1
Contamination 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 340 342
Unspecified Infection 324 324
No Code Available 53 53
No Information 27 27
Hypersensitivity/Allergic reaction 20 20
Failure of Implant 18 18
No Consequences Or Impact To Patient 6 6
Numbness 5 5
Cyst(s) 5 5
Swelling 5 5
Swelling/ Edema 5 5
No Known Impact Or Consequence To Patient 4 4
Missing Value Reason 4 4
Reaction 4 4
Abscess 3 3
Discomfort 3 3
Inflammation 3 3
Necrosis 2 4
Rash 2 2
Erythema 2 2
Complaint, Ill-Defined 2 2
Burning Sensation 2 2
Tingling 2 2
Insufficient Information 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Injury 1 1
Malaise 1 1
Osteolysis 1 1
Caustic/Chemical Burns 1 1
Tissue Breakdown 1 3
Foreign Body In Patient 1 1
Fistula 1 1
Foreign Body Reaction 1 1
Granuloma 1 1
Hair Loss 1 1
Dysphagia/ Odynophagia 1 1
Edema 1 1
Increased Sensitivity 1 1
Tinnitus 1 1
Undesired Nerve Stimulation 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Ormco/Sybronendo II Sep-16-2016
2 Sybron Dental Specialties II Mar-02-2010
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