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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
PARKELL, INC.
  SUBSTANTIALLY EQUIVALENT 1
RIZHAO HUGE BIOMATERIALS COMPANY, LTD.
  SUBSTANTIALLY EQUIVALENT 1
ULTRADENT PRODUCT, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 1 1
2022 1 1
2023 2 2
2024 1 1
2025 6 6

Device Problems MDRs with this Device Problem Events in those MDRs
Patient-Device Incompatibility 5 5
Material Too Soft/Flexible 5 5
Adverse Event Without Identified Device or Use Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Insufficient Information 5 5
Hypersensitivity/Allergic reaction 2 2
Pain 2 2
Abdominal Pain 1 1
Inflammation 1 1
Reaction to Medicinal Component of Device 1 1
Itching Sensation 1 1
Erythema 1 1

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