FDA 510(k) Applications Submitted by SOMNOMED INC.

FDA 510(k) Number Submission Date Device Name Applicant
K073004 10/24/2007 SOMNOMED BFLEX SOMNOMED INC.
K102521 09/02/2010 PANTINO PRO POSITINER SOMNOMED INC.
K183443 12/12/2018 SomnoDent Avant SomnoMed Inc.
K121340 05/03/2012 SOMNODENT G2 SOMNOMED INC.
K140278 02/03/2014 SOMNODENT FUSION, CLASSIC; SOMNODENT FUSION, FLEX SOMNOMED INC.
K130558 03/04/2013 SOMNODENT HERBST; CLASSIC, FLEX SOMNOMED INC.
K162306 08/17/2016 SomnoDent ALPHA SomnoMed Inc.
K150369 02/13/2015 SomnoDent Classic with DentiTrac Micro-recorder, SomnoDent Flex with DentiTrac Micro-recorder, SomnoDent Herbst Advance (Classic or Flex Retention) with DentiTrac Micro-recorder, SomnoDent G2 (Classic or Flex Retention) with DentiTrac Micro-recorder, Somn SOMNOMED INC.


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