THERMOFORMED MOUTHGUARDS (K121365) - FDA 510(k) Clearance

K121365 is an FDA 510(k) clearance for the THERMOFORMED MOUTHGUARDS. Classified as Mouthguard, Prescription (product code MQC).

Submitted by Glidewell Laboratories-Sleep Devices Group (Irvine, US). The FDA issued a Cleared decision on November 20, 2012 after a review of 197 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.

View all Glidewell Laboratories-Sleep Devices Group devices