FDA.reportPublic FDA data

Ioana Gabel

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30053438493005343849Ioana Gabel1N2026-01-016513 Windcrest Dr Ste 100 Plano TX US 75024
30094409733009440973Ioana Gabel1N2026-01-016513 Windcrest Dr Ste 100 Plano TX US 75024

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1314211425682021K261366
648461425682021K261366
1314211795428702K183443SomnoDent AvantLRK2019-05-08
648461795428702K183443SomnoDent AvantLRK2019-05-08
1314211554782392K162306SomnoDent ALPHALRK2016-09-20
648461554782392K162306SomnoDent ALPHALRK2016-09-20
648461008706457K150369SomnoDent 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
1314211008706457K150369SomnoDent 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
648461084835193K140278SOMNODENT FUSION, CLASSIC; SOMNODENT FUSION, FLEXLRK2014-06-20
1314211084835193K140278SOMNODENT FUSION, CLASSIC; SOMNODENT FUSION, FLEXLRK2014-06-20
648461179302948K130558SOMNODENT HERBST; CLASSIC, FLEXLRK2013-05-17
1314211179302948K130558SOMNODENT HERBST; CLASSIC, FLEXLRK2013-05-17
1314211782835977K102909SOMNOBRUX SPLINTSMQC2011-12-13
648461782835977K102909SOMNOBRUX SPLINTSMQC2011-12-13
1314211665973894K073004SOMNOMED BFLEXLRK2008-01-30
648461665973894K073004SOMNOMED BFLEXLRK2008-01-30
1314211496648509K050592SOMNOMED MAS RXALRK2005-07-12
648461496648509K050592SOMNOMED MAS RXALRK2005-07-12
1314211452314683K023836THE SUAD DEVICELRK2003-07-08
1314211486864240
648461903846556
1314211903846556

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LRK132019-05-08
PLC22015-06-18
MQC22011-12-13