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APEX DENTAL SLEEP LAB

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30127160383012716038APEX DENTAL SLEEP LAB1N2026-01-017863 La Mesa Suite 204 La Mesa CA US 91942

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00860008847508KAVA DORSAL ACRYLIC - A dental acrylic oral appliance intended for mandibular advancement and positioning during sleep therapy.619-724-6040sonnie@apexsleep.com
00860008847515KAVA HERBST ACRYLIC - A custom acrylic oral appliance intended to support mandibular positioning during sleep therapy.6197246040sonnie@apexsleep.com
00860008847522KAVA DORSAL DUAL LAMINATE - A Dental Dual-Laminate oral appliance intended for mandibular advancement and positioning during sleep therapy for the treatment of snoring and obstructive sleep apnea.6197246040sonnie@apexsleep.com
00860008847539KAVA HERBST DUAL LAMINATE - A Dental Dual laminate oral appliance intended for mandibular advancement and positioning during sleep therapy for the treatment of snoring and obstructive sleep apnea.6197246040sonnie@apexsleep.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2082251868006056K232735EMA 3DLRK2024-05-03
2082251612394530K182661Kava and Kava with HerbstLRK2019-02-13
2082251270634323K152159Oravan HerbstLRK2015-10-29
2082251623444743K150369SomnoDent 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
2082251996964634K143244The Panthera Anti-Snoring DeviceLRK2014-12-15
2082251816628805K140278SOMNODENT FUSION, CLASSIC; SOMNODENT FUSION, FLEXLRK2014-06-20
2082251038037188K133683MICR02 OSA DEVICELRK2014-07-24
2082252026853819K130558SOMNODENT HERBST; CLASSIC, FLEXLRK2013-05-17
2082251156250393K121340SOMNODENT G2LRK2012-05-30
2082251554666431K121285ORAVAN OSALRK2013-03-08
2082252006909898K073004SOMNOMED BFLEXLRK2008-01-30
2082251675724052K050592SOMNOMED MAS RXALRK2005-07-12
2082251099657816
2082251359394780
2082251594522707
2082251840617667

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LRK112024-05-03
PLC12015-06-18

GUDID#