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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device activator, ultraviolet, for polymerization
Regulation Description Ultraviolet activator for polymerization.
Product CodeEBZ
Regulation Number 872.6070
Device Class 2


Premarket Reviews
ManufacturerDecision
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 2
GARRISON DENTAL SOLUTIONS, LLC
  SUBSTANTIALLY EQUIVALENT 2
GENOSS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
GOOD DOCTORS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
GUILIN REFINE MEDICAL INSTRUMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HANDPIECE HEADQUARTERS
  SUBSTANTIALLY EQUIVALENT 1
PREMIUM PLUS (DONGGUAN) LIMITED
  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
Adverse Event Without Identified Device or Use Problem 1 1
Electrical Shorting 1 1
Protective Measures Problem 1 1
Improper or Incorrect Procedure or Method 1 1

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

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