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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
IVOCLAR VIVADENT, AG
  SUBSTANTIALLY EQUIVALENT 1
NANOVA BIOMATERIALS INC
  SUBSTANTIALLY EQUIVALENT 1
PREMIER DENTAL COMPANY PRODUCTS
  SUBSTANTIALLY EQUIVALENT 1
PULPDENT CORPORATION
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Abdominal Pain 1 1
Pain 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Ivoclar Vivadent, Inc. II Feb-29-2016
2 Ultradent Products, Inc. II Dec-03-2016
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