FDA Opens Performance Pathway To Four Dental Device Types

Guidance documents issued 30 September explain how makers of air powered dental handpieces and air motors, dental cements, dental ceramics, and dental impression materials can bring their products to market by demonstrating compliance with established criteria, without a direct comparison to a predicate device.

The US Food and Drug Administration is adding four additional dental device types to the Safety and Performance Based Pathway, easing the products’ path to market.

The pathway, which was established in 2019 as an outgrowth of the Abbreviated 510(k) program, allows some types of devices...

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