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NEOBIOTECH

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30047303683004730368NEOBIOTECH CO., LTD.1N2026-01-0170, Sinpyeong-ro, Jijeong-myeon Wonju-si Gangwon KR 26351

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
232581160893260K232528Protective CapNHA2024-04-30
232581387531961K232049IS-III active Short ImplantDZE2024-03-28
232581519017853K210903IS Multi Unit Abutment SystemNHA2021-07-23
232581316936910K190849IS-III active System_S-narrow TypeDZE2019-08-14
232581374010878K181178S-mini active FixtureDZE2018-07-24
232581636639476K181138IS-III active SystemDZE2018-10-03
232581721443006K181137IT-III active SystemDZE2018-11-16
232581130658639K173938IS-III HActive FixtureDZE2018-05-24
232581556534619K160991Neo GBR SystemDZL2017-01-10
232581108879198K120503CMI IMPLANT IS II ACTIVEDZE2012-06-18
232581087142696K113554CMI IMPLANT IS SYSTEMDZE2012-04-05
232581387110187K112540S-MINI IMPLANT SYSTEMDZE2012-02-03
232581191114082K111761NEO TITANIUM MESH, CTI-MEMJEY2012-01-10
232581033737958K090825SQ IS SYSTEMDZE2009-07-16
232582061403035K090527SINUS QUICK IT SYSTEMDZE2009-07-14
232581293542279K090377SINUS QUICK EB SYSTEMDZE2009-08-28
232581729990124K042339NEOPLANT IMPLANT SYSTEMDZE2004-11-02
232581140244116
232581144222417
232581513017120
232581635950420
232581720341420

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DZE132024-03-28
NHA22024-04-30
DZL12017-01-10
JEY12012-01-10

PMN#

GUDID#

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