K212448 - NightGuard Flex (FDA 510(k) Clearance)

K212448 is an FDA 510(k) clearance for the NightGuard Flex. Classified as Mouthguard, Prescription (product code MQC).

Submitted by Sprintray, Inc. (Los Angeles, US). The FDA issued a Cleared decision on November 12, 2021 after a review of 99 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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