FDA guidance

Dental Handpieces - Premarket Notification [510(k)] Submissions: Guidance for Industry and…

FDA guidance · Final · issued May 2, 2007

Key facts

Title Dental Handpieces - Premarket Notification [510(k)] Submissions: Guidance for Industry and FDA Staff
Status Final
Issue date May 2, 2007
Center Center for Devices and Radiological Health
Issuing office Center for Devices and Radiological Health
Communication type Guidance Document
Regulated product Medical Devices
Topics Premarket
Docket number FDA-2020-D-0957
Open for comment No
Document on fda.gov fda.gov

At a glance

  • 10–99 Product codes referenced
  • 1–9 Recognized standards referenced

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About FDA guidance documents

FDA guidance documents describe the agency's current thinking on regulatory topics. Drafts are issued for comment before a final version is published.

Source: U.S. Food and Drug Administration (FDA), Guidance Documents

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