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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device coating, filling material, resin
Product CodeEBD
Regulation Number 872.3310
Device Class 2


Premarket Reviews
ManufacturerDecision
BELPORT COMPANY, INC., GINGI-PAK
  SUBSTANTIALLY EQUIVALENT 1
VITA ZAHNFABRIK GMBH H RAUTER & CO
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 1 1
2023 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Use of Device Problem 2 2
Patient-Device Incompatibility 2 2
Adverse Event Without Identified Device or Use Problem 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
Hypersensitivity/Allergic reaction 6 6
Dyspnea 5 5
Swelling/ Edema 5 5
Dizziness 1 1
Abdominal Distention 1 1
Unspecified Respiratory Problem 1 1

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