subject device / chemical composition / handpiece systems / cleared devices / hand-held device / marketed device / /
Organization
U.S. Department of Health and Human Services / Food and Drug Administration / Division of Dockets Management / Food and Drug Administration Center for Devices / Radiological Health Dental Devices Branch Division of Anesthesiology / FDA / General Hospital / Dental Devices office of Device Evaluation Contains Nonbinding Recommendations Preface Public Comment Written / /
Guidance for Industry and FDA Staff Dental Handpieces - Premarket Notification [510(k)] Submissions Document issued on: May 2, 2007 This guidance supersedes “Guidance Document on Dental Handpieces” issued July 1995