G-Series Grind Guard (K260790) - FDA 510(k) Clearance

K260790 is an FDA 510(k) clearance for the G-Series Grind Guard. Classified as Mouthguard, Over-the-counter (product code OBR).

Submitted by ASESSO HEALTH, Inc. (Pleasanton, US). The FDA issued a Cleared decision on June 25, 2026 after a review of 106 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.

View all ASESSO HEALTH, Inc. devices