K262280 - Mouth guard

K262280 is an FDA 510(k) clearance for the Mouth guard. Classified as Mouthguard, Over-the-counter (product code OBR).

Submitted by Dongguan Yiyao Science & Technology Development Co., Ltd. (Dongguan, CN). The FDA issued a Cleared decision on October 26, 2026 after a review of 112 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.