K183315 - CustMBite Dental Guard (FDA 510(k) Clearance)

K183315 is an FDA 510(k) clearance for the CustMBite Dental Guard. Classified as Mouthguard, Over-the-counter (product code OBR).

Submitted by Dental Choice Holdings, LLC (Louisville, US). The FDA issued a Cleared decision on August 23, 2019 after a review of 266 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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