Per the notice below, the United States Food and Drug Administration (FDA) has issued four final guidances on dental ceramics, dental cements, dental impression materials, and air-powered dental handpieces and air motors.

FDA Issues Four Dental Final Guidances on Performance Criteria for Safety and Performance Based Pathway

In support of our goal to strengthen and modernize the 510(k) medical device program, the U.S. Food and Drug Administration (FDA) issued the following four final guidances:

• Dental Ceramics - Performance Criteria for Safety and Performance Based Pathway
• Dental Cements - Performance Criteria for Safety and Performance Based Pathway
• Dental Impression Materials - Performance Criteria for Safety and Performance Based Pathway
• Air-Powered Dental Handpieces and Air Motors - Performance Criteria for Safety and Performance Based Pathway

Under the Safety and Performance Based Pathway, medical device manufacturers planning to submit a 510(k) for these devices will have the option to use the performance criteria identified in these guidances to support substantial equivalence, rather than a direct comparison of the performance of the subject device to that of a predicate device.  The FDA strongly encourages the medical device industry to continue to provide the FDA with recommendations for additional types of devices that would benefit from inclusion in future guidances regarding performance criteria and testing methodologies for the Safety and Performance Based Pathway using the docket number FDA-2018-D-1387 at Regulations.gov.

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