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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device bone grafting material, dental, with biologic component
Definition Dental bone grafting material with growth factors is a combination product which consists of a bone grafting material which contains biologic or drug components, such as proteins, that are intended to stimulate and/or inhibit the growth of certain tissues of the oral and maxillofacial region.
Product CodeNPZ
Regulation Number 872.3930
Device Class 3

Premarket Approvals (PMA)
2019 2020 2021 2022 2023 2024
7 5 5 4 5 3

MDR Year MDR Reports MDR Events
2023 17 17

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Osseointegrate 17 17

Patient Problems MDRs with this Patient Problem Events in those MDRs
Failure of Implant 17 17

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