FDA.reportPublic FDA data

DIAMOND ORTHOTIC LABORATORY, LLC

Matched from indexed company URL: Diamond Orthotic Lab

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30127288463012728846DIAMOND ORTHOTIC LABORATORY, LLC1N2026-01-017859 El Cajon Blvd. La Mesa CA US 91942

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2254501166069944K973884ELASTIC MANDIBULAR ADVANCEMENT - TITRATION (EMA-T) APPILANCELRK1998-01-09
2254502021747984K202499Diamond Digital Sleep Orthotic (DDSO)LRK2020-09-03
2254501892078721K181482myTAP2LRK2018-08-31
2254501368275816K160239TAP 3, TAP 1PLC2016-08-10
2254501869996448K130558SOMNODENT HERBST; CLASSIC, FLEXLRK2013-05-17
2254501988169393K073004SOMNOMED BFLEXLRK2008-01-30
2254501316794004K050592SOMNOMED MAS RXALRK2005-07-12
2254501387384385K030440OASYS-ORAL AIRWAY SYSTEMLRK2003-08-26
2254501990243210

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LRK72020-09-03
PLC12016-08-10

PMN#

GUDID#

Diamond Digital Sleep Orthotic (DDSO) - The Diamond Digital Sleep Orthotic (DDSO) is a removable intraoral device intended to reduce or alleviate snoring and mild to moderate obstructive sleep apnea (OSA) in adults. The device functions as a mandibular repositioner, maintaining the lower jaw in a forward, (protrusive) position during sleep. This mechanical protrusion acts to increase the patient’s pharyngeal space and decrease air turbulence, therefore improving their ability to exchange air during sleep.

Diamond Orthotic Lab

2020-09-24