TPLC - Total Product Life Cycle

• Device: sealant, pit and fissure, and conditioner
• Product Code: EBC
• Regulation Number: 872.3765
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
3M COMPANY
	SUBSTANTIALLY EQUIVALENT	1
APEX DENTAL MATERIALS, INC.
	SUBSTANTIALLY EQUIVALENT	1
BISCO, INC.
	SUBSTANTIALLY EQUIVALENT	1
CLASSONE ORTHODONTICS, INC.
	SUBSTANTIALLY EQUIVALENT	1
DENALI R&D CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
DMG USA, INC.
	SUBSTANTIALLY EQUIVALENT	1
DMP LTD
	SUBSTANTIALLY EQUIVALENT	1
HERAEUS KULZER, LLC
	SUBSTANTIALLY EQUIVALENT	1
ITENA CLINICAL
	SUBSTANTIALLY EQUIVALENT	1
IVOCLAR VIVADENT, AG
	SUBSTANTIALLY EQUIVALENT	1
NANOVA BIOMATERIALS INC
	SUBSTANTIALLY EQUIVALENT	1
NOVOCOL INC. DBA SEPTODONT AND CONFI-DENTAL PRODUC
	SUBSTANTIALLY EQUIVALENT	1
PAC-DENT INTERNATIONAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
PREMIER DENTAL COMPANY PRODUCTS
	SUBSTANTIALLY EQUIVALENT	1
PULPDENT CORPORATION
	SUBSTANTIALLY EQUIVALENT	2
RIZHAO HUGE BIOMATERIALS COMPANY, LTD.
	SUBSTANTIALLY EQUIVALENT	1
SHOFU DENTAL CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
ULTRADENT PRODUCT, INC.
	SUBSTANTIALLY EQUIVALENT	1
ULTRADENT PRODUCTS, INC.
	SUBSTANTIALLY EQUIVALENT	2
VERICOM CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
VOCO GMBH
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2020	1	1
2022	1	1
2023	2	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Patient-Device Incompatibility	3	3
Adverse Event Without Identified Device or Use Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Pain	2	2
Reaction to Medicinal Component of Device	1	1
Abdominal Pain	1	1
Erythema	1	1
Inflammation	1	1
Itching Sensation	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Ivoclar A. G.	II	Nov-04-2015
2	Ivoclar Vivadent, Inc.	II	Feb-29-2016
3	Ultradent Products, Inc.	II	Dec-03-2016