Animal Studies for Dental Bone Grafting Material Devices - Premarket Notification (510(k)) Submissions: Draft Guidance for Industry and Food and Drug Administration Staff

Name: Animal Studies for Dental Bone Grafting Material Devices - Premarket Notification (510(k)) Submissions: Draft Guidance for Industry and Food and Drug Administration Staff
Creator: Food and Drug Administration
Keywords: 510k,animal-studies,bone,dental,draft,fda,guidances,industry,materials,notification,pre-market,pre-market-notification,submissions

Information

Type

Guidance

Regulated products

Medical Devices

Topics

Premarket

Published

March 29, 2024

Last updated

March 28, 2024

Description

Draft guidance document for industry and FDA staff on premarket notification submissions for dental bone grafting material devices in animal studies.

Organization

Food and Drug Administration (FDA) 🇺🇸

Country / Region

United States

License

Other (Public Domain)

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1 Main file

Animal Studies for Dental Bone Grafting Material Devices - Premarket Notification (510(k)) Submissions: Draft Guidance for Industry and Food and Drug Administration Staff

Updated on March 28, 2024

pdf (686.6KB)

URL: https://www.fda.gov/media/177340/download
Permalink: https://data.openrid.co/en/datasets/r/9108f42e-3369-475f-9fcd-bde289cf0dea
MIME Type: application/pdf

Created on: March 29, 2024
Modified on: March 28, 2024

Size: 686.6KB

Animal Studies for Dental Bone Grafting Material Devices - Premarket Notification (510(k)) Submissions: Draft Guidance for Industry and Food and Drug Administration Staff

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