FDA.reportPublic FDA data

BIOMATERIALS KOREA INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30055152283005515228BIOMATERIALS KOREA INC.1N2026-01-01#413 #329 #331 150, Jojeong-daero Hanam-si Gyeonggi KR

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
660591633502792K222245ACR Screw SystemOAT2023-08-21
660591029662603K173623Anchor plateOAT2018-08-30
660591290845170K111809SL TYPE ORTHODONTIC ANCHOR SCREWS, SPL TYPE ORTHODONTIC ANCHOR SCREWSOAT2011-09-26
660591081687161K110926BONE PLATE; BONE SCREWJEY2011-12-08
660591463205270K063495C TYPE, CT TYPE, AND SPECIAL TYPE ORTHODONTIC ANCHOR SCREWSOAT2007-07-26
660591082862157
660591161637293
660591189299253
660591512074590
660591527888654
660591564345237
660591594552366
660591678187304
660591690409072
660591690755171
660591697051316
660591697498110
660591764750652
660591841702163
660591845047556

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
OAT42023-08-21
JEY12011-12-08

PMN#