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TPLC
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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
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
2
GOOD DOCTORS CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
GUILIN REFINE MEDICAL INSTRUMENT CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
HANDPIECE HEADQUARTERS
SUBSTANTIALLY EQUIVALENT
1
ULTRADENT PRODUCTS, INC
SUBSTANTIALLY EQUIVALENT
1
ULTRADENT PRODUCTS, INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2020
2
2
2021
4
4
2022
5
5
2023
7
7
2024
3
3
Device Problems
MDRs with this Device Problem
Events in those MDRs
Overheating of Device
14
14
Insufficient Information
4
4
Use of Device Problem
3
3
Excessive Heating
2
2
Output above Specifications
1
1
Protective Measures Problem
1
1
Adverse Event Without Identified Device or Use Problem
1
1
Electrical Shorting
1
1
Improper or Incorrect Procedure or Method
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Pain
7
7
Burn(s)
6
6
Discomfort
6
6
Inflammation
6
6
No Clinical Signs, Symptoms or Conditions
2
2
Burning Sensation
2
2
Full thickness (Third Degree) Burn
2
2
Loss of Vision
1
1
Eye Pain
1
1
Eye Burn
1
1
Burn, Thermal
1
1
Fungal Infection
1
1
Swelling/ Edema
1
1
Headache
1
1
Skin Erosion
1
1
Superficial (First Degree) Burn
1
1
Chemical Exposure
1
1
Unspecified Tissue Injury
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Envisiontec US Llc
II
Mar-10-2022
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