Cleared Traditional

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

K102909 · Somnomed, Inc. · Dental device
Dec 2011
Decision
438d
Days
-
Risk

K102909 is an FDA 510(k) clearance for the SOMNOBRUX SPLINTS. This device is classified as a Mouthguard, Prescription.

Submitted by Somnomed, Inc. (Frisco, US). The FDA issued a Cleared decision on December 13, 2011, 438 days after receiving the submission on October 1, 2010.

This device falls under the Dental FDA review panel.

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

Device Classification

Product Code MQC - Mouthguard, Prescription
Device Class -