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DIADENT GROUP INTERNATIONAL

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
96161283010138769DIADENT GROUP INTERNATIONAL1N2027-01-0116, Osongsaengmyeong 4-Ro, Osong-Eup HEUNGDUKGU CHONGJU CITY Chungbuk KR 28161

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
177652030416177K261166DIA-CEMEMA2026-07-09
177651306474622K261093DIAFILEBF2026-06-02
177651757048225K261071DIAFIL Bulk FLOW (Economic Package);DIAFIL Bulk FLOW (Refill Package);DIAFIL Bulk FLOW (0.5g)EBF2026-05-19
177651809045640K254152Dia-X Sil Light BodyELW2026-09-16
177651850867302K254142Dia-X Sil Heavy BodyELW2026-09-16
177651136761195K254112Dia-X Sil BiteELW2026-03-19
177651523614406K231552Dia-CemEMA2023-07-28
177651568727008K220804Dia-X Bond UniversalKLE2022-06-15
177651648412279K210421Diafil & Diafil CapsuleEBF2021-06-28
177651784267475K210333DiaPasteKIF2021-03-25
177651155757321K200809D-LUX+EBZ2020-08-07
177651233688969K200175DIA-ROOT BIO SealerKIF2020-06-25
177651633894197K200174DIA-ROOT BIO MTAKIF2020-09-18
177651080280154K192510DIAFIL & DIAFIL CapsuleEBF2020-03-20
177651797709536K192392DiaPlusKLE2020-05-26
177651375648068K192284DiaFil FlowEBF2020-03-25
177651032101204K192273DIAETCH Economic Package Type A, DIATECH Regular Package, DIAETCH Refill Package Type A, DIAETCH Intro KitKLE2020-02-07
177651967301405K192158DiaTempEBG2020-02-13
177651962400621K192022DiaTemp FlowEBG2020-02-13
177651679071352K190091DiapasteKIF2020-03-27
177651983541973K182625Diapex PlusKIF2019-06-03
177651186945588K182009Dia-ProsealKIF2019-09-26
177651536161939K130163D-LUXEBZ2013-08-16
177651448110809K090992WELL-PASTEKIF2009-04-21
177651853481564K033585DIAPEXKIF2004-01-16
177651007586730
177651024561035
177651197568266
177651227651872
177651810780098
177651024263947
177651081359712
177651127409615
177651185026367
177651209262448
177651252757343
177651343834506
177651588560301
177651715139618
177651733894243
177651748478276
177651772274616
177651798758925
177651924571445
177652029421877

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
KIF82021-03-25
EBF52026-06-02
ELW32026-09-16
KLE32022-06-15
EMA22026-07-09
EBZ22020-08-07
EBG22020-02-13

PMN#

GUDID#

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