K181005 - ClenchGuard (FDA 510(k) Clearance)

K181005 is an FDA 510(k) clearance for the ClenchGuard. Classified as Mouthguard, Over-the-counter (product code OBR).

Submitted by Boyd Research, Inc. (Solana Beach, US). The FDA issued a Cleared decision on January 15, 2020 after a review of 639 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.

View all Boyd Research, Inc. devices