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Somnomed, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
11
Inspections
3
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K233497Rest Assure SystemOctober 3, 2024
K183443SomnoDent AvantMay 8, 2019
K162306SomnoDent ALPHASeptember 20, 2016
K150369SomnoDent Classic with DentiTrac Micro-recorder, SomnoDent Flex with DentiTrac Micro-recorder, SomnoJune 18, 2015
K140278SOMNODENT FUSION, CLASSIC; SOMNODENT FUSION, FLEXJune 20, 2014
K130558SOMNODENT HERBST; CLASSIC, FLEXMay 17, 2013
K121340SOMNODENT G2May 30, 2012
K102909SOMNOBRUX SPLINTSDecember 13, 2011
K102521PANTINO PRO POSITINERMarch 28, 2011
K073004SOMNOMED BFLEXJanuary 30, 2008
K050592SOMNOMED MAS RXAJuly 12, 2005