Medical Device Manufacturer · US , Denton , TX

Somnomed, Inc. - FDA 510(k) Cleared Devices

11 submissions · 11 cleared · Since 2008

Recent clearances: Rest Assure System, SomnoDent Avant

11

Total

11

Cleared

0

Denied

FDA 510(k) Regulatory Record - Somnomed, Inc. Dental ✕

11 devices

1-11 of 11

Cleared Jun 12, 2026

Cleared Oct 03, 2024

Rest Assure System

Cleared May 08, 2019

SomnoDent Avant

Cleared Sep 20, 2016

SomnoDent ALPHA

Cleared Jun 18, 2015

SomnoDent Classic with DentiTrac Micro-recorder, SomnoDent Flex with...

Cleared Jun 20, 2014

SOMNODENT FUSION, CLASSIC

Cleared May 17, 2013

SOMNODENT HERBST

Cleared May 30, 2012

Cleared Dec 13, 2011

SOMNOBRUX SPLINTS

Cleared Mar 28, 2011

PANTINO PRO POSITINER

Cleared Jan 30, 2008