K082723 - GRINDGUARD (FDA 510(k) Clearance)

K082723 is an FDA 510(k) clearance for the GRINDGUARD. Classified as Mouthguard, Prescription (product code MQC).

Submitted by Grind Guard Technologies, LLC (Leola, US). The FDA issued a Cleared decision on August 31, 2009 after a review of 348 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.

View all Grind Guard Technologies, LLC devices