EZ SPLINT & EZ SPLINT PM (K022809) - FDA 510(k) Clearance

K022809 is an FDA 510(k) clearance for the EZ SPLINT & EZ SPLINT PM. Classified as Mouthguard, Prescription (product code MQC).

Submitted by Power Products, Inc.-Splintek (Great Neck, US). The FDA issued a Cleared decision on October 17, 2003 after a review of 420 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 Power Products, Inc.-Splintek devices