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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
EPIC MEDICAL CONCEPTS & INNOVATIONS
  SUBSTANTIALLY EQUIVALENT 1
KERR CORP.
  SUBSTANTIALLY EQUIVALENT 1
KMIHH LTD
  SUBSTANTIALLY EQUIVALENT 1
MONITEX INDUSTRIAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 5
NATIONAL DENTAL INC.
  SUBSTANTIALLY EQUIVALENT 1
PREMIUM PLUS INTERNATIONAL LIMITED
  SUBSTANTIALLY EQUIVALENT 1
PROMIDENT LLC/ JOHNSON-PROMIDENT
  SUBSTANTIALLY EQUIVALENT 1
SATELEC-ACTEON GROUP
  SUBSTANTIALLY EQUIVALENT 1
SYBRON DENTAL SPECIALTIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
ULTRADENT PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 2
VOCO GMBH
  SUBSTANTIALLY EQUIVALENT 1
  1.  K153018  CELALUX 3

Device Problems
Output Problem 6
Device Operates Differently Than Expected 4
Adverse Event Without Identified Device or Use Problem 2
Improper or Incorrect Procedure or Method 1
Labelling, Instructions for Use or Training Problem 1
Device Issue 1
Environmental Compatibility Problem 1
Device Handling Problem 1
Total Device Problems 17

Recalls
Manufacturer Recall Class Date Posted
1 Handpiece Headquarters II Feb-04-2019
2 Ivoclar Vivadent, Inc. II Jun-09-2014

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