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Megagen Implant Co., Ltd. FDA Approvals

0 new drug approvals and 18 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product
MegaGen Zygoma Dental Implant System510(k)Jun 18, 2026Dental
MegaGen Dental Implant Abutment510(k)Jan 13, 2025Dental
BLUEDIAMOND IMPLANT510(k)Dec 27, 2024Dental
TiGEN Abutment, PMMA Abutment and Scan Healing Abutment510(k)Sep 18, 2024Dental
N2510(k)Mar 21, 2024Dental
MegaGen 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 Screw510(k)Jan 22, 2024Dental
ARi ExCon Implant System510(k)Dec 7, 2023Dental
R2GATE Lite TM510(k)Oct 20, 2023Radiology
MegaGen Dental Implant Systems Portfolio - MR Conditional510(k)Oct 11, 2023Dental
Bone Chamber Implant510(k)Jul 18, 2023Dental
N2510(k)Apr 5, 2023Dental
BLUEDIAMOND IMPLANT, Abutment Screw510(k)Jan 6, 2023Dental
R2 Studio Q/RCT820510(k)Dec 6, 2022Radiology
TiGEN Abutment, ZrGEN Abutment and Scan Healing Abutment510(k)Nov 10, 2022Dental
Healing Abutment, Cover Screw510(k)Feb 3, 2022Dental
Multi-unit Abutment, Multi-unit Angled Abutment510(k)Oct 20, 2021Dental
AnyOne External Implant System510(k)Aug 28, 2021Dental
AnyOne Onestage Implant System510(k)Jun 22, 2021Dental

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