TPLC - Total Product Life Cycle

• Device: cleanser, root canal
• Product Code: KJJ
• Device Class: Unclassified

Premarket Reviews
Manufacturer	Decision
CERKAMED WOJCIECH PAWLOWSKI
	SUBSTANTIALLY EQUIVALENT	1
DENTSPLY INTL., INC.
	SUBSTANTIALLY EQUIVALENT	1
EPIEN MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	2
ESSENTIAL DENTAL SYSTEMS, INC.
	SUBSTANTIALLY EQUIVALENT	1
ESSENTIAL DENTAL SYSTESM, INC.
	SUBSTANTIALLY EQUIVALENT	1
INSTITUT STRAUMANN AG
	SUBSTANTIALLY EQUIVALENT	1
INTER-MED / VISTA DENTAL
	SUBSTANTIALLY EQUIVALENT	1
INTER-MED, INC.
	SUBSTANTIALLY EQUIVALENT	3
INTER-MED/ VISTA DENTAL PRODUCTS
	SUBSTANTIALLY EQUIVALENT	1
INTER-MED/VISTA DENTAL PRODUCTS
	SUBSTANTIALLY EQUIVALENT	1
OCULUS INNOVATIVE SCIENCES
	SUBSTANTIALLY EQUIVALENT	1
PAC-DENT INTERNATIONAL, INC.
	SUBSTANTIALLY EQUIVALENT	3
PAC-DENT, INC
	SUBSTANTIALLY EQUIVALENT	1
ULTRADENT PRODUCTS, INC.
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2014	1	1
2015	3	3
2016	2	2
2018	1	1
2019	1	1
2020	1	1
2023	2	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Insufficient Information	4	4
Patient-Device Incompatibility	2	2
Human-Device Interface Problem	1	1
Contamination /Decontamination Problem	1	1
Overfill	1	1
Use of Device Problem	1	1
Improper or Incorrect Procedure or Method	1	1
Migration	1	1
Improper Chemical Reaction	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Swelling	5	5
Pain	3	3
Hypersensitivity/Allergic reaction	2	2
Reaction	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Skin Inflammation/ Irritation	1	1
Chemical Exposure	1	1
No Known Impact Or Consequence To Patient	1	1
Burning Sensation	1	1
Erythema	1	1
Numbness	1	1
No Patient Involvement	1	1
Unspecified Tissue Injury	1	1
Tissue Damage	1	1

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