Slow Wave DS8 (SWDS802) (K240463) - FDA 510(k) Clearance

K240463 is an FDA 510(k) clearance for the Slow Wave DS8 (SWDS802). Classified as Mouthguard, Prescription (product code MQC).

Submitted by Slow Wave, Inc. (Spicewood, US). The FDA issued a Cleared decision on June 4, 2024 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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