FDA.report

MegaGen Implant Co., Ltd. (Research Laboratories)

Matched from indexed company URL: Megagen Implant Co. Ltd

FDA Registration(s)

RegistrationFEINameStatusInitial importerExpiration yearAddress
30300898023030089802MegaGen Implant Co., Ltd. (Research Laboratories)1N2026-01-0119, Alphacity 1-ro 31-gil, Suseong-gu Daegu KR 42250

Registered Device Listings

Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3229881893881668K242030MegaGen Dental Implant AbutmentNHA2025-01-13
3229881423881643K241972BLUEDIAMOND IMPLANTDZE2024-12-27
3229881654530430K240754N2EIA2024-03-21
3229881333746462K234142TiGEN Abutment, PMMA Abutment and Scan Healing AbutmentNHA2024-09-18
3229881902090593K233450MegaGen Dental Implant Abutment - Scan Healing Abutment; Temporary Abutment; Temporary Cylinder; Comfort Cap; Healing Cap; Healing Cap Screw; Milling Abutment; EZ Post Abutment; Extra EZ Post Abutment; EZ Post Cylinder; ZrGEN Abutment; Multi-unit Abutment; Multi-unit Angled Abutment; AXA Abutment (Straight); AXA Abutment (Angled); Abutment Screw; Cylinder Screw; Crown ScrewNHA2024-01-22
3229881603869596K231967ARi ExCon Implant SystemDZE2023-12-07
3229881010595986K230618MegaGen Dental Implant Systems Portfolio - MR ConditionalDZE2023-10-11
3229881147337671K222219R2 Studio Q/RCT820OAS2022-12-06
3229881502751712K220562TiGEN Abutment, ZrGEN Abutment and Scan Healing AbutmentNHA2022-11-10
3229881950051708K211812BLUEDIAMOND IMPLANT, Abutment ScrewDZE2023-01-06
3229881369203357K211556N2EIA2023-04-05
3229881103500354K210826Healing Abutment, Cover ScrewNHA2022-02-03
3229881650364437K210161AnyOne Onestage Implant SystemDZE2021-06-22
3229881124987015K203808Multi-unit Abutment, Multi-unit Angled AbutmentNHA2021-10-20
3229881983307181K203554AnyOne External Implant SystemDZE2021-08-28
3229881033447262K192614Meg-Ball Attachment System, Meg-Loc Abutment, Meg-Magnet AbutmentNHA2020-02-13
3229881253830436K192347ST Internal Implant SystemDZE2019-11-14
3229881194513725K191127Advanced Intermezzo Implant SystemDZE2019-10-08
3229881319931695K182448AnyRidge Octa 1 Implant SystemDZE2019-10-09
3229881859151994K150537MiNi Internal Implant SystemDZE2015-07-21
3229882055141094K140091XPEED ANYRIDGE INTERNAL IMPLANT SYSYEMDZE2014-12-12
3229881099353193K131289I-GENJEY2013-09-25
3229881594784288K123988ANYONETM INTERNAL IMPLANT SYSTEMDZE2013-08-15
3229881466880642K123870XPEED ANYRIDGE INTERNAL IMPLANT SYSTEMDZE2013-03-27
3229881666571632K122231XPEED ANY RIDGE INTERNAL IMPLANT SYSTEMDZE2012-10-04
3229881984577880K110955ANYRIDGE INTERNAL IMPLANT SYSTEMDZE2011-11-22
3229881704121171K101890BALL ABUTMENT SYSTEMNHA2011-02-03
3229882011854617K081302RESCUE EXTERNAL IMPLANT SYSTEMDZE2008-08-15
3229881087895732K073058RESCUE INTERNAL IMPLANT SYSTEMDZE2008-04-11
3229881198555716K070562EZ PLUS IMPLANT SYSTEMNHA2007-05-18
3229881510328692K063216RESCUE INTERNAL IMPLANT SYSTEMDZE2007-04-02
3229881431738643K053353RESCUE IMPLANT SYSTEMDZE2006-04-19
3229881723961532K052369EXFEEL IMPLANT SYSTEMDZE2006-01-10
3229881435667144K051018INTERMEZZO IMPLANT SYSTEMSDZE2005-09-02
3229881060345818
3229881086210943
3229881133842912
3229881166762257
3229881477458599
3229881477690564
3229881485559665
3229881505631340
3229881552614089
3229881578143502
3229881894813817
3229881913131927
3229882031362114
3229882053814847

Product Codes Associated With Registrations

Product codeRegistration listing recordsLatest decision
DZE212024-12-27
NHA92025-01-13
EIA22024-03-21
OAS12022-12-06
JEY12013-09-25

PMA

PMN

R2GATE

2019-06-26

MegaGen Implant Co., Ltd.

I-GEN

2013-09-25

MEGAGEN IMPLANT CO., LTD

Applications

GUDID