K091660 - CUSTOM COMFORT NIGHTGUARD VERSION 2 (FDA 510(k) Clearance)

K091660 is an FDA 510(k) clearance for the CUSTOM COMFORT NIGHTGUARD VERSION 2. Classified as Mouthguard, Over-the-counter (product code OBR).

Submitted by Den Tek Oral Care, Inc. (Washington, US). The FDA issued a Cleared decision on June 12, 2009 after a review of 3 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Den Tek Oral Care, Inc. devices