Dental Handpieces - Premarket Notification [510(k)] Submissions
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.
Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)
If unable to submit comments online, please mail written comments to:
Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852
All comments should be identified with the title of the guidance.