K223798 - Glidewell TuffSplint™ Appliance Resin (FDA 510(k) Clearance)

K223798 is an FDA 510(k) clearance for the Glidewell TuffSplint™ Appliance Resin. Classified as Mouthguard, Prescription (product code MQC).

Submitted by Prismatik Dentalcraft, Inc. (Irvine, US). The FDA issued a Cleared decision on February 17, 2023 after a review of 60 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Prismatik Dentalcraft, Inc. devices