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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
CAO GROUP, INC.
  SUBSTANTIALLY EQUIVALENT 1
DENTALL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
DENTALL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
DENTLIGHT INC.
  SUBSTANTIALLY EQUIVALENT 1
DENTMATE TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
DIADENT GROUP INTERNATIONAL
  SUBSTANTIALLY EQUIVALENT 1
FOSHAN CICADA DENTAL INSTRUMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
KERR CORP.
  SUBSTANTIALLY EQUIVALENT 1
KMIHH LTD
  SUBSTANTIALLY EQUIVALENT 1
MONITEX INDUSTRIAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 4
NATIONAL DENTAL INC.
  SUBSTANTIALLY EQUIVALENT 1
PREMIUM PLUS INTERNATIONAL LIMITED
  SUBSTANTIALLY EQUIVALENT 1
PROMIDENT LLC/ JOHNSON-PROMIDENT
  SUBSTANTIALLY EQUIVALENT 1
SYBRON DENTAL SPECIALTIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
ULTRADENT PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 2
VOCO GMBH
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2015 8 8
2016 2 2
2017 5 5
2018 3 3
2020 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Device Operates Differently Than Expected 8 8
Use of Device Problem 2 2
Insufficient Information 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Handpiece 1 1
Battery 1 1
Material Rupture 1 1
Improper or Incorrect Procedure or Method 1 1
Electrical Shorting 1 1
Device Handling Problem 1 1
Device Issue 1 1
Environmental Compatibility Problem 1 1
Charred 1 1
Labelling, Instructions for Use or Training Problem 1 1
Melted 1 1
Overheating of Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Code Available 5 5
Burning Sensation 4 4
No Patient Involvement 3 3
Full thickness (Third Degree) Burn 2 2
Burn(s) 2 2
Skin Erosion 1 1
No Consequences Or Impact To Patient 1 1
No Known Impact Or Consequence To Patient 1 1
Complaint, Ill-Defined 1 1
Burn, Thermal 1 1
Necrosis 1 1
Pain 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Handpiece Headquarters II Feb-04-2019
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