K102909 - SOMNOBRUX SPLINTS (FDA 510(k) Clearance)

K102909 is an FDA 510(k) clearance for the SOMNOBRUX SPLINTS. Classified as Mouthguard, Prescription (product code MQC).

Submitted by Somnomed, Inc. (Frisco, US). The FDA issued a Cleared decision on December 13, 2011 after a review of 438 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 Somnomed, Inc. devices