TPLC - Total Product Life Cycle

• Device: activator, ultraviolet, for polymerization
• Regulation Description: Ultraviolet activator 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
DENTMATE TECHNOLOGY CO. , LTD.
	SUBSTANTIALLY EQUIVALENT	1
FOSHAN COXO MEDICAL INSTRUMENT CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
GARRISON DENTAL SOLUTIONS, LLC
	SUBSTANTIALLY EQUIVALENT	1
GENOSS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
GOOD DOCTORS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
GUANGZHOU REBORNENDO MEDICAL INSTRUMENT CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
GUILIN REFINE MEDICAL INSTRUMENT CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
HANDPIECE HEADQUARTERS
	SUBSTANTIALLY EQUIVALENT	1
META SYSTEMS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
PREMIUM PLUS (DONGGUAN) LIMITED
	SUBSTANTIALLY EQUIVALENT	1
ULTRADENT PRODUCTS, INC.
	SUBSTANTIALLY EQUIVALENT	2

MDR Year	MDR Reports	MDR Events
2021	4	4
2022	5	5
2023	7	7
2024	3	3
2025	1	1
2026	3	3

Device Problems	MDRs with this Device Problem	Events in those MDRs
Overheating of Device	13	13
Insufficient Device Problem Information	4	4
Excessive Heating	3	3
Output above Specifications	1	1
Improper or Incorrect Procedure or Method	1	1
Vibration	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Burn(s)	7	7
Pain	7	7
Inflammation	6	6
Discomfort	6	6
No Clinical Signs, Symptoms or Conditions	4	4
Burning Sensation	2	2
Loss of Vision	1	1
Eye Burn	1	1
Insufficient Information	1	1
Superficial (First Degree) Burn	1	1
Swelling/ Edema	1	1
Unspecified Tissue Injury	1	1
Headache	1	1
Eye Pain	1	1
Fungal Infection	1	1
Chemical Exposure	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Envisiontec US Llc	II	Mar-10-2022