TPLC - Total Product Life Cycle

show TPLC since

Device	activator, ultraviolet, for polymerization
Product Code	EBZ
Regulation Number	872.6070
Device Class	2

Premarket Reviews
Manufacturer	Decision
CHANGZHOU SIFARY MEDICAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
DENT4YOU AG
	SUBSTANTIALLY EQUIVALENT	1
DENTLIGHT INC.
	SUBSTANTIALLY EQUIVALENT	1
DENTMATE TECHNOLOGY CO. LTD.
	SUBSTANTIALLY EQUIVALENT	1
DENTSPLY SIRONA
	SUBSTANTIALLY EQUIVALENT	1
DIADENT GROUP INTERNATIONAL
	SUBSTANTIALLY EQUIVALENT	1
DXM CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
EZGO GROUP INC.
	SUBSTANTIALLY EQUIVALENT	1
FOSHAN CICADA DENTAL INSTRUMENT CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
FOSHAN COXO MEDICAL INSTRUMENT CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
GARRISON DENTAL SOLUTIONS, LLC
	SUBSTANTIALLY EQUIVALENT	1
GOOD DOCTORS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
GUILIN REFINE MEDICAL INSTRUMENT CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
HANDPIECE HEADQUARTERS
	SUBSTANTIALLY EQUIVALENT	1
IVOCLAR VIVADENT, AG
	SUBSTANTIALLY EQUIVALENT	1
KMIHH LTD
	SUBSTANTIALLY EQUIVALENT	1
ULTRADENT PRODUCTS, INC
	SUBSTANTIALLY EQUIVALENT	1
ULTRADENT PRODUCTS, INC.
	SUBSTANTIALLY EQUIVALENT	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Overheating of Device	13	13
Insufficient Information	4	4
Use of Device Problem	3	3
Excessive Heating	2	2
Output above Specifications	1	1
Electrical Shorting	1	1
Adverse Event Without Identified Device or Use Problem	1	1
Protective Measures Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Inflammation	6	6
Pain	6	6
Discomfort	6	6
Burn(s)	5	5
No Clinical Signs, Symptoms or Conditions	2	2
Full thickness (Third Degree) Burn	2	2
Eye Pain	1	1
Unspecified Tissue Injury	1	1
Swelling/ Edema	1	1
Headache	1	1
Eye Burn	1	1
Burn, Thermal	1	1
Superficial (First Degree) Burn	1	1
Skin Erosion	1	1
Loss of Vision	1	1
Burning Sensation	1	1