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FDA 510(k)

MegaGen Dental Implant Systems Portfolio - MR Conditional

K-Number: K230618 · 2023-10-11

ApplicantMegagen Implant Co., Ltd.
Decision Date2023-10-11
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

MegaGen Dental Implant Systems Portfolio - MR Conditional is a medical device manufactured by Megagen Implant Co., Ltd.. It received FDA 510(k) clearance on 2023-10-11 under approval number K230618. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MegaGen Dental Implant Systems Portfolio - MR Conditional?

MegaGen Dental Implant Systems Portfolio - MR Conditional is a medical device that received FDA 510(k) clearance on 2023-10-11. It is manufactured by Megagen Implant Co., Ltd.. The 510(k) number is K230618.

When was MegaGen Dental Implant Systems Portfolio - MR Conditional approved by the FDA?

MegaGen Dental Implant Systems Portfolio - MR Conditional received FDA 510(k) clearance on 2023-10-11, under approval number K230618.

What company makes MegaGen Dental Implant Systems Portfolio - MR Conditional?

MegaGen Dental Implant Systems Portfolio - MR Conditional is manufactured by Megagen Implant Co., Ltd..

What is the FDA product code for MegaGen Dental Implant Systems Portfolio - MR Conditional?

The FDA product code for MegaGen Dental Implant Systems Portfolio - MR Conditional is DZE.

Related Clinical Trials

NCT07608302 Comparison of the Predictability of Dentoalveolar Expansion With Two Clear Aligner Systems COMPLETED NCT07605286 Soft Tissue Augmentation Around Dental Implants COMPLETED NCT07589140 Influence of Alveolar Bone Drilling and Anatomical Position on Integration NOT_YET_RECRUITING NCT07246499 Multicentre Study on the Impact of Transmucosal Abutment Surface Characteristics on Peri-implant Tissues. ACTIVE_NOT_RECRUITING NCT07586163 Effectiveness of Clear Aligner Systems in Mixed Dentition Maxillary Transverse Deficiency ACTIVE_NOT_RECRUITING NCT07240493 BMP Effect on Implant Stability and Marginal Bone Level After Immediate Placement COMPLETED

Related PubMed Literature

PMID: 40774046 Strengthening Dental Materiovigilance: A Review of International Reporting Frameworks. International dental journal (2025)

Other Devices by Megagen Implant Co., Ltd.

K192347ST Internal Implant System K182448AnyRidge Octa 1 Implant System K191127Advanced Intermezzo Implant System K190096R2GATE K192614Meg-Ball Attachment System, Meg-Loc Abutment, Meg-Magnet Abutment K203808Multi-unit Abutment, Multi-unit Angled Abutment

View all 22 devices →

Related Devices (Code: DZE)

K160475Ritter Dental Implant SystemRitter Implants GmbH & Co. KG K161244s-Clean OneQ-SL Narrow Implant SystemDentis Co., Ltd. K163043Zeramex P6 Dental Implant SystemDentalpoint AG K161497Dental Implants and AbutmentsDitron Precision, Ltd. K153332ETIII SA Fixture System (O3.2mm)Hiossen, Inc. K151970KJ Mini Implant SystemKj Meditech Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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