K222845 - Clench Relief Mouth Piece PRO RX, Clench Relief Mouth Piece (FDA 510(k) Clearance)

K222845 is an FDA 510(k) clearance for the Clench Relief Mouth Piece PRO RX, Clench Relief Mouth Piece. Classified as Mouthguard, Prescription (product code MQC).

Submitted by Frey Oral Technologies, LLC (Beverly Hills, US). The FDA issued a Cleared decision on November 28, 2023 after a review of 433 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Dental submissions.

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