FDA.reportPublic FDA data

COWELLMEDI CO., LTD.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30051151163005115116COWELLMEDI CO., LTD.1N2026-01-0148, Hakgam-daero 221beon-gil Sasang-Gu BUSAN KR 46986

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
238741973606835K242287SFIT AbutmentNHA2025-09-16
238741626524630K241127INNO SLA Mini Plus® Implant SystemDZE2024-12-27
238741919089992K232546Meta G UCLA AbutmentNHA2023-11-21
238741337276326K231411INNO SLA Submerged Hybrid Ti-Base SystemNHA2023-12-20
238741331922109K231395INNO SLA Submerged Narrow Implant SystemDZE2023-10-18
238741001321288K211554InnoGenic Non-resorbable MembraneNPK2023-02-24
238741406434704K201323INNO SLA Submerged Implant SystemNHA2022-01-25
238741156523899K132242INNO SLA SUBMERGED IMPLANT SYSTEMDZE2013-12-06
238741170751894K100850COWELL IMPLANT SYSTEMDZE2010-12-20
238741280322972K090054ATLAS IMPLANT SYSTEM - WIDE PLUSDZE2009-07-29
238741576763701K090049ATLAS IMPLANT SYSTEM- MINI PLUSDZE2009-04-20
238741104157529K071148ATLAS IMPLANT SYSTEMDZE2008-02-06
238741385716003K050635ALLFIM IMPLANT SYSTEMSDZE2005-07-28
238741640674577K041655BIO PLANT SYSTEM (IMPLANTS AND ABUTMENTS)DZE2004-09-08
238741233371970
238741175071146
238741508350746
238741910665060

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DZE92024-12-27
NHA42025-09-16
NPK12023-02-24

PMN#