FDA.reportPublic FDA data

SOMNOMED INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30055985363005598536SOMNOMED INC.1Y2026-01-016513 Windcrest Dr Ste 100 Plano TX US 75024
30070758983007075898SOMNOMEDICS AMERICA INC.1Y2026-01-01815 Ponce de Leon Blvd Suite P-209 Coral Gables FL US 33134

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
238651795428702K183443SomnoDent AvantLRK2019-05-08
238651554782392K162306SomnoDent ALPHALRK2016-09-20
238651008706457K150369SomnoDent 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, SomnoDent Fusion (Classic or Flex Retention) with DentiTrac Micro-recorderPLC2015-06-18
238651084835193K140278SOMNODENT FUSION, CLASSIC; SOMNODENT FUSION, FLEXLRK2014-06-20
238651179302948K130558SOMNODENT HERBST; CLASSIC, FLEXLRK2013-05-17
238651782835977K102909SOMNOBRUX SPLINTSMQC2011-12-13
238651665973894K073004SOMNOMED BFLEXLRK2008-01-30
238651496648509K050592SOMNOMED MAS RXALRK2005-07-12
238651452314683K023836THE SUAD DEVICELRK2003-07-08
238651486864240
238651860141751
238651903846556

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LRK72019-05-08
PLC12015-06-18
MQC12011-12-13

PMN#

DreamClear

2024-09-04

Somnomed Technologies Inc., Doing Business AS Remware

GUDID#

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