Dental Composite Resin Devices - Premarket Notification (510(k)) Submissions: Draft Guidance for Industry and Food and Drug Administration Staff

Name: Dental Composite Resin Devices - Premarket Notification (510(k)) Submissions: Draft Guidance for Industry and Food and Drug Administration Staff
Creator: Food and Drug Administration
Keywords: 510k,dental,draft,fda,guidances,industry,notification,pre-market,pre-market-notification,submissions

Information

Type

Guidance

Regulated products

Medical Devices

Topics

Premarket

Published

July 12, 2024

Last updated

July 11, 2024

Description

A draft guidance document for industry and FDA staff on premarket notification (510(k)) submissions for dental composite resin devices.

Organization

Food and Drug Administration (FDA) 🇺🇸

Country / Region

United States

License

Other (Public Domain)

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1 Main file

Dental Composite Resin Devices - Premarket Notification (510(k)) Submissions: Draft Guidance for Industry and Food and Drug Administration Staff

Updated on July 11, 2024

pdf (533.0KB)

URL: https://www.fda.gov/media/179983/download
Permalink: https://data.openrid.co/en/datasets/r/aeb74c59-4ef2-4475-9b78-b7d40e38350b
MIME Type: application/pdf

Created on: July 12, 2024
Modified on: July 11, 2024

Size: 533.0KB

Dental Composite Resin Devices - Premarket Notification (510(k)) Submissions: Draft Guidance for Industry and Food and Drug Administration Staff

Information

Type

Regulated products

Topics

Published

Last updated

Description

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Country / Region

License

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