FDA Panel Recommends Reclassifying Blade-Form Dental Implants

Posted on October 9, 2013

 

A US Food and Drug Administration (FDA) advisory committee panel overseeing dental products recommended Friday the reclassification of blade-form endosseous dental implants, also known as blade- or plate-form implants, from a Class III, "high risk" medical device regulatory status, requiring premarket approval, to a "medium risk," Class II, with special controls as provisions for the marketing of the implants, according to Medscape Today.

The FDA's Dental Products Panel itself proposed the reclassification in January, and the agency says it has gathered sufficient evidence demonstrating the implants to be acceptably safe for the reclassification.

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