Cleared Traditional

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

K102909 · Somnomed, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2011
Decision
438d
Days
-
Risk

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

Submission Details

510(k) Number K102909 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 01, 2010
Decision Date December 13, 2011
Days to Decision 438 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
311d slower than avg
Panel avg: 127d · This submission: 438d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MQC Mouthguard, Prescription
Device Class -