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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device sealant, pit and fissure, and conditioner
Regulation Description Pit and fissure sealant and conditioner.
Product CodeEBC
Regulation Number 872.3765
Device Class 2


Premarket Reviews
ManufacturerDecision
APEX DENTAL MATERIALS, INC.
  SUBSTANTIALLY EQUIVALENT 1
BISCO, INC.
  SUBSTANTIALLY EQUIVALENT 1
NANOVA BIOMATERIALS INC
  SUBSTANTIALLY EQUIVALENT 1
PAC-DENT INC.
  SUBSTANTIALLY EQUIVALENT 1
PULPDENT CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
VOCO GMBH
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Adverse Event Without Identified Device or Use Problem 1
Device Component Or Accessory 1
Total Device Problems 2

Recalls
Manufacturer Recall Class Date Posted
1 Ivoclar A. G. II Nov-04-2015
2 Ivoclar Vivadent, Inc. II Feb-29-2016
3 Ultradent Products, Inc. II Dec-03-2016

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