K212706 - SleepRight ProRx + Custom Dental Guard, SleepRight ProRx Custom Dental Guard (FDA 510(k) Clearance)

K212706 is an FDA 510(k) clearance for the SleepRight ProRx + Custom Dental Guard, SleepRight ProRx Custom Dental Guard. Classified as Mouthguard, Over-the-counter (product code OBR).

Submitted by Splintek, Inc. (Lenexa, US). The FDA issued a Cleared decision on December 13, 2021 after a review of 109 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

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