FDA.reportPublic FDA data

Ortho Solutions LC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
19371001937100Ortho Solutions LC1N2026-01-018050 Hawk Ridge Trail Lake Saint Louis MO US 63367

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
338031100921902K955292AELITEFLOEBF1995-12-13
338031073410833K230225DynaFlex Clear Brackets & ButtonsNJM2023-06-05
338032056708751K214096Respire ClearLRK2022-05-31
338031984746580K192127Respire Pink AT (Hard, Hard/Soft, EF)LRK2020-02-05
338031732107972K190583DynaFlexNXC2019-06-27
338031200584666K170692Respire Pink Series with DentiTracLRK2017-05-26
338031680835780K152292Respire Blue Series-EFLRK2015-12-07
338031984632665K150572Respire Pink Series-Herbst-EFLRK2015-08-27
338031016108746K141421PMMA BLOCKEBG2015-02-09
338031476391297K131138RESPIRE PINK SERIES - HERBSTLRK2013-09-09
338032034189390K120471MACH BRACKETS BRIGHT BRACKETSNJM2012-06-04
338032016417807K111207RESPIRE BLUE SERIESLRK2011-08-23
338031011260764K103076DYNAFLEXLRK2011-02-23
338031204620927K090567ORTHODONTIC CERAMIC BRACKETNJM2009-05-27
338031550275849K082408LEDEX, MODEL: WL-070EBZ2008-12-03
338031035688683
338031067694808
338031117471225
338031139783634
338031146164879
338031187389927
338031199779377
338031212705448
338031229365431
338031232958698
338031236511401
338031239613489
338031241606103
338031243254364
338031245532727
338031287501368
338031303530611
338031368087557
338031378086531
338031405839258
338031416319201
338031427191414
338031453900084
338031568020529
338031573869522
338031587621345
338031635044541
338031638997007
338031647484216
338031761414462
338031818893403
338031905551900
338031936622318
338031954859063
338031956254719
338031969771840
338031974809371
338031980525201
338031983121125
338031986951591
338032010834304
338032029316577
338032047357393
338032058199318

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LRK82022-05-31
NJM32023-06-05
NXC12019-06-27
EBG12015-02-09
EBZ12008-12-03
EBF11995-12-13