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GUIDANCE DOCUMENT

Dental Handpieces - Premarket Notification [510(k)] Submissions Guidance for Industry and FDA Staff May 2007

Download the Final Guidance Document
Final
Docket Number:
FDA-2020-D-0957
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health

FDA has developed this guidance document to assist industry in preparing premarket notification submissions (510(k)s) for dental handpieces intended to prepare dental cavities for restorations, such as fillings, and for cleaning teeth. (21 CFR 872.4200). This guidance supersedes the document entitled, Guidance Document on Dental Handpieces issued July 1995. It updates the references and clarifies the recommendations.

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You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

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All written comments should be identified with this document's docket number: FDA-2020-D-0957.

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