TPLC - Total Product Life Cycle

• Device: varnish, cavity
• Product Code: LBH
• Regulation Number: 872.3260
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
3M COMPANY
	SUBSTANTIALLY EQUIVALENT	1
3M ESPE DENTAL PRODUCTS
	SUBSTANTIALLY EQUIVALENT	1
BELPORT COMPANY, INC., GINGI-PAK
	SUBSTANTIALLY EQUIVALENT	1
BISCO, INC
	SUBSTANTIALLY EQUIVALENT	1
DR. COLLINS, INC.
	SUBSTANTIALLY EQUIVALENT	2
ELEVATE ORAL CARE
	SUBSTANTIALLY EQUIVALENT	1
GUANGZHOU BEOGENE BIOTECH CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
IVOCLAR VIVADENT, AG
	SUBSTANTIALLY EQUIVALENT	1
JOHNSON & JOHNSON HEALTHCARE PRODUCTS, DIVISION OF MCNEIL-PP
	SUBSTANTIALLY EQUIVALENT	1
KETTENBACH GMBH & CO. KG
	SUBSTANTIALLY EQUIVALENT	1
LARGENT HEALTH, LLC
	SUBSTANTIALLY EQUIVALENT	2
SANGI CO, LTD
	SUBSTANTIALLY EQUIVALENT	1
SCIENTIFIC PHARMACEUTICALS
	SUBSTANTIALLY EQUIVALENT	1
VERICOM CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
YOUNG DENTAL MANUFACTURING CO 1, LLC.
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2015	14	14
2016	12	12
2017	11	11
2018	13	13
2019	9	9
2020	10	10
2021	15	15
2022	7	7
2023	8	8
2024	4	4

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	47	47
Patient-Device Incompatibility	29	29
Improper or Incorrect Procedure or Method	13	13
Insufficient Information	10	10
Use of Device Problem	7	7
Labelling, Instructions for Use or Training Problem	3	3
Device Handling Problem	2	2
Biocompatibility	2	2
Disconnection	1	1
Extrusion	1	1
Burst Container or Vessel	1	1
Malposition of Device	1	1
Inadequate Instructions for Healthcare Professional	1	1
Patient Device Interaction Problem	1	1
Explosion	1	1
Human-Device Interface Problem	1	1
Improper Chemical Reaction	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Burning Sensation	28	28
Hypersensitivity/Allergic reaction	22	22
Pain	18	18
Swelling	17	17
Reaction	15	15
Swelling/ Edema	9	9
Local Reaction	9	9
Caustic/Chemical Burns	8	8
Vomiting	8	8
No Code Available	8	8
Inflammation	7	7
Headache	6	6
Nausea	5	5
Rash	5	5
Ulcer	4	4
Discomfort	4	4
Burn(s)	4	4
Abdominal Pain	4	4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	4	4
Skin Inflammation/ Irritation	4	4
Anaphylactic Shock	3	3
Numbness	3	3
Erythema	3	3
Sensitivity of Teeth	2	2
Erosion	2	2
Patient Problem/Medical Problem	2	2
Dysphagia/ Odynophagia	2	2
Dyspnea	2	2
Tingling	2	2
Complaint, Ill-Defined	2	2
Emotional Changes	2	2
Injury	2	2
No Known Impact Or Consequence To Patient	2	2
Skin Discoloration	2	2
Chemical Exposure	2	2
Itching Sensation	2	2
Pallor	1	1
Diarrhea	1	1
Memory Loss/Impairment	1	1
Dizziness	1	1
Irritation	1	1
Fever	1	1
Confusion/ Disorientation	1	1
Liver Damage/Dysfunction	1	1
Congenital Defect/Deformity	1	1
Tooth Fracture	1	1
Cough	1	1
Contact Dermatitis	1	1
Myalgia	1	1
Superficial (First Degree) Burn	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	3M Company - Health Care Business	II	Nov-02-2018
2	Keystone Industries	II	Sep-12-2023
3	Ultradent Products, Inc.	II	Jan-03-2019
4	Young Dental Manufacturing Co, LLC	II	Dec-09-2019
5	Young Dental Manufacturing I, LLC	II	Jun-08-2023