TPLC - Total Product Life Cycle

• Device: resin, root canal filling
• Product Code: KIF
• Regulation Number: 872.3820
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
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
PREVEST DENPRO LIMITED
	SUBSTANTIALLY EQUIVALENT	1
SEPTODONT
	SUBSTANTIALLY EQUIVALENT	3
1.  K172839  ENDOSOLV
2.  K211799  Biodentine XP 500, Biodentine XP 200
3.  K212283  BioRoot Flow 0.5g, BioRoot Flow 2g
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