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Megagen Implant Co., Ltd.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
31
Inspections
2
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K242030MegaGen Dental Implant AbutmentJanuary 13, 2025
K241972BLUEDIAMOND IMPLANTDecember 27, 2024
K234142TiGEN Abutment, PMMA Abutment and Scan Healing AbutmentSeptember 18, 2024
K240754N2March 21, 2024
K233450MegaGen Dental Implant Abutment - Scan Healing Abutment; Temporary Abutment; Temporary Cylinder; ComJanuary 22, 2024
K231967ARi ExCon Implant SystemDecember 7, 2023
K223909R2GATE Lite TMOctober 20, 2023
K230618MegaGen Dental Implant Systems Portfolio - MR ConditionalOctober 11, 2023
K223339Bone Chamber ImplantJuly 18, 2023
K211556N2April 5, 2023
K211812BLUEDIAMOND IMPLANT, Abutment ScrewJanuary 6, 2023
K222219R2 Studio Q/RCT820December 6, 2022
K220562TiGEN Abutment, ZrGEN Abutment and Scan Healing AbutmentNovember 10, 2022
K210826Healing Abutment, Cover ScrewFebruary 3, 2022
K203808Multi-unit Abutment, Multi-unit Angled AbutmentOctober 20, 2021
K203554AnyOne External Implant SystemAugust 28, 2021
K210161AnyOne Onestage Implant SystemJune 22, 2021
K192614Meg-Ball Attachment System, Meg-Loc Abutment, Meg-Magnet AbutmentFebruary 13, 2020
K192347ST Internal Implant SystemNovember 14, 2019
K182448AnyRidge Octa 1 Implant SystemOctober 9, 2019