Medical Device Manufacturer · US , Santa Fe Springs , CA

Megagen Implant Co., Ltd. - FDA 510(k) Cleared Devices

31 submissions · 31 cleared · Since 2008

Recent clearances: MegaGen Dental Implant Abutment, BLUEDIAMOND IMPLANT, TiGEN Abutment, PMMA Abutment and Scan Healing Abutment

Total

Cleared

Denied

Megagen Implant Co., Ltd. has 31 FDA 510(k) cleared dental devices. Based in Santa Fe Springs, US.

Latest FDA clearance: Jan 2025. Active since 2008.

Browse the complete list of FDA 510(k) cleared dental devices from this manufacturer. Filter by specialty or product code using the sidebar.

Regulatory submissions have been managed by Daegyeong Regulatory Affairs Institute, Mtechgroup and LK Consulting Group USA, Inc..

Megagen Implant Co., Ltd. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.

FDA 510(k) Regulatory Record - Megagen Implant Co., Ltd.

31 devices

1-12 of 31

Cleared Jan 13, 2025

MegaGen Dental Implant Abutment

TiGEN Abutment, PMMA Abutment and Scan Healing Abutment

MegaGen Dental Implant Abutment - Scan Healing Abutment

K233450 · NHA

Dental · 94d

Cleared Dec 07, 2023

ARi ExCon Implant System

MegaGen Dental Implant Systems Portfolio - MR Conditional

BLUEDIAMOND IMPLANT, Abutment Screw

Data Source

Sourced from the FDA 510(k) public files . 175,218 total devices indexed.

Last updated: Apr 27, 2026

Megagen Implant Co., Ltd. - FDA 510(k) Cleared Devices

FDA 510(k) Regulatory Record - Megagen Implant Co., Ltd.

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