Dental Handpieces – Premarket Notification [510(k)] Submissions: Guidance for Industry and FDA Staff

Issue Date: May 2, 2007
Issued by: Center for Devices and Radiological Health
Topic(s): Premarket,
Status: Final

Dental Handpieces – Premarket Notification [510(k)] Submissions: Guidance for Industry and FDA Staff

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.

Download the Guidance Document