NIGHT GUARD (K061122) - FDA 510(k) Clearance

K061122 is an FDA 510(k) clearance for the NIGHT GUARD. Classified as Mouthguard, Prescription (product code MQC).

Submitted by Alpine Oral Care, LLC (Houston, US). The FDA issued a Cleared decision on March 12, 2007 after a review of 322 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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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