TPLC - Total Product Life Cycle

• Device: adhesive, bracket and tooth conditioner, resin
• Product Code: DYH
• Regulation Number: 872.3750
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
3M UNITEK
	SUBSTANTIALLY EQUIVALENT	1
3M UNITEK CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
3M UNITEK ORTHODONTIC PRODUCTS
	SUBSTANTIALLY EQUIVALENT	1
AMERICAN ORTHODONTICS
	SUBSTANTIALLY EQUIVALENT	2
BISCO, INC.
	SUBSTANTIALLY EQUIVALENT	1
DANVILLE MATERIALS, LLC.
	SUBSTANTIALLY EQUIVALENT	2
DAVILLE MATERIALS LLC
	SUBSTANTIALLY EQUIVALENT	1
DENTSCARE LTDA
	SUBSTANTIALLY EQUIVALENT	1
DENTSPLY INTL., INC.
	SUBSTANTIALLY EQUIVALENT	1
GC ORTHODONTICS AMERICA INC.
	SUBSTANTIALLY EQUIVALENT	2
LARGENT HEALTH, LLC
	SUBSTANTIALLY EQUIVALENT	1
NOVOCOL, INC.
	SUBSTANTIALLY EQUIVALENT	1
PULPDENT CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
RELIANCE ORTHODONTIC PRODUCTS INC.
	SUBSTANTIALLY EQUIVALENT	2
RELIANCE ORTHODONTIC PRODUCTS, INC.
	SUBSTANTIALLY EQUIVALENT	4
TP ORTHODONTICS, INC.
	SUBSTANTIALLY EQUIVALENT	1
ULTRADENT PRODUCTS, INC.
	SUBSTANTIALLY EQUIVALENT	4
VOCO GMBH
	SUBSTANTIALLY EQUIVALENT	2

MDR Year	MDR Reports	MDR Events
2014	2	2
2015	2	2
2016	1	1
2017	5	5

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	5	5
Patient-Device Incompatibility	3	3
Device Operates Differently Than Expected	1	1
Material Discolored	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Tooth Fracture	3	3
Reaction	2	2
Sensitivity of Teeth	1	1
Eye Injury	1	1
Headache	1	1
Pain	1	1
Local Reaction	1	1
Skin Irritation	1	1
Swelling	1	1
Dizziness	1	1
Osteolysis	1	1