K250743 - Remvia NightGuard (FDA 510(k) Clearance)

K250743 is an FDA 510(k) clearance for the Remvia NightGuard. Classified as Mouthguard, Prescription (product code MQC).

Submitted by Remvia (St. Louis, US). The FDA issued a Cleared decision on December 5, 2025 after a review of 269 days - an extended review cycle.

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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