IMI

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30051767273005176727IMICRYL DIS MALZEMELERI SANAYI VE TICARET A.S.1N2026-01-01Fetih Mahallesi Mahir Sokak No:5/201 Karatay/Konya Konya TR 42030
30087874493008787449IMI Healing Technologies Inc.1N2020-04-251600 Stelles Ave W. Unit 21 Concord Ontario CA L4K 4M2

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2374001369213216K220077IMICRYL Composite, Composite Flow MaterialsEBF2022-08-09
2374001190195687K213890IMICRYL Impression MaterialsELW2022-02-11
2374001738945942K213609NOVA RESIN dual cure, self adhesive resin cementEMA2022-08-09
2374001985733342K210473Nova Glass Cements (Nova Glass L, Nova Glass F, Nova Glass LC, Nova Glass BF, Nova Glass L Plus)EMA2021-11-02
2374001379943241K192913R&D Series Nova Compo-B Plus Bottle, R&D Series Nova Compo-B Plus Single DoseKLE2021-01-19
2374001858431497K192178R&D Series Nova Compo NEBF2019-12-20
1252342028240207K073689LEP2000 THERAPY SYSTEMNHN2008-11-13
2374001034623543
2374001117180467
2374001128135945
2374001185596670
2374001196369291
2374001198406182
2374001237801492
2374001260982377
2374001270536563
2374001316136121
2374001334384993
2374001352093863
2374001352153436
2374001368512340
2374001381631502
2374001396012409
2374001427326001
2374001472956084
2374001479342943
2374001481830185
2374001521968756
2374001623025109
2374001683315325
2374001727922244
2374001732950495
2374001738135841
2374001750170280
2374001781693376
2374001795679032
2374001798892992
2374001799406839
2374001817481859
2374001931243789
2374001939198138
2374002064738318

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
EBF22022-08-09
EMA22022-08-09
ELW12022-02-11
KLE12021-01-19
NHN12008-11-13

PMN#

IMIG-MRI

1996-12-18

IMIG-MRI SYSTEMS, LLC.