FDA.reportPublic FDA data

SOMNOMED, LTD.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30053438493005343849SOMNOMED, LTD.1N2027-01-01LEVEL 3, 20 CLARKE ST. CROWS NEST New South Wales AU NSW 2065

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
648461425682021K261366VirtusLRK2026-06-12
648461487850131K233497Rest Assure SystemPLC2024-10-03
648461795428702K183443SomnoDent AvantLRK2019-05-08
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
648461084835193K140278SOMNODENT FUSION, CLASSIC; SOMNODENT FUSION, FLEXLRK2014-06-20
648461179302948K130558SOMNODENT HERBST; CLASSIC, FLEXLRK2013-05-17
648461782835977K102909SOMNOBRUX SPLINTSMQC2011-12-13
648461665973894K073004SOMNOMED BFLEXLRK2008-01-30
648461496648509K050592SOMNOMED MAS RXALRK2005-07-12
648461903846556

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LRK72026-06-12
PLC22024-10-03
MQC12011-12-13