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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device liner, cavity, calcium hydroxide
Regulation Description Calcium hydroxide cavity liner.
Product CodeEJK
Regulation Number 872.3250
Device Class 2


Premarket Reviews
ManufacturerDecision
3M ESPE DENTAL PRODUCTS
  SUBSTANTIALLY EQUIVALENT 1
DMP DENTAL INDUSTRY S.A.
  SUBSTANTIALLY EQUIVALENT 1
MARUCHI
  SUBSTANTIALLY EQUIVALENT 1
PREVEST DENPRO LIMITED
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2022 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Patient-Device Incompatibility 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Hypersensitivity/Allergic reaction 1 1

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