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FDA 510(k)

MegaGen Dental Implant Abutment

K-Number: K242030 · 2025-01-13

ApplicantMegagen Implant Co., Ltd.
Decision Date2025-01-13
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

MegaGen Dental Implant Abutment is a medical device manufactured by Megagen Implant Co., Ltd.. It received FDA 510(k) clearance on 2025-01-13 under approval number K242030. The device is classified under product code NHA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MegaGen Dental Implant Abutment?

MegaGen Dental Implant Abutment is a medical device that received FDA 510(k) clearance on 2025-01-13. It is manufactured by Megagen Implant Co., Ltd.. The 510(k) number is K242030.

When was MegaGen Dental Implant Abutment approved by the FDA?

MegaGen Dental Implant Abutment received FDA 510(k) clearance on 2025-01-13, under approval number K242030.

What company makes MegaGen Dental Implant Abutment?

MegaGen Dental Implant Abutment is manufactured by Megagen Implant Co., Ltd..

What is the FDA product code for MegaGen Dental Implant Abutment?

The FDA product code for MegaGen Dental Implant Abutment is NHA.

Related Clinical Trials

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 NCT07240493 BMP Effect on Implant Stability and Marginal Bone Level After Immediate Placement COMPLETED NCT05883202 Effect of the Abutment-Prosthesis Connection on Marginal Bone Loss and Gingival Sealing Around Dental Implants SUSPENDED NCT07580495 Effect of Collagen Membrane on Ridge Preservation NOT_YET_RECRUITING

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: NHA)

K161713Dentium CAD/CAM AbutmentsDentium Co., Ltd. K160798IPS e.max® Press Abutment Solutions for Viteo Base TiIvoclar Vivadent, AG K162004PREMIUM Implant Systems SHELTA Implant SystemsSweden & Martina S.P.A. K153015Transfer & Angled AbutmentOsstem Implant Co., Ltd. K161435Temporary Snap AbutmentNobel Biocare AB K160786RODO Abutment SystemRodo Medical, Inc.

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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