K150492 - Ora-GUARD Dental Grind Guard (FDA 510(k) Clearance)

K150492 is an FDA 510(k) clearance for the Ora-GUARD Dental Grind Guard. Classified as Mouthguard, Over-the-counter (product code OBR).

Submitted by Bite Tech, Inc. (Norwalk, US). The FDA issued a Cleared decision on February 19, 2016 after a review of 359 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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