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FDA 510(k)

Meg-Ball Attachment System, Meg-Loc Abutment, Meg-Magnet Abutment

K-Number: K192614 · 2020-02-13

ApplicantMegagen Implant Co., Ltd.
Decision Date2020-02-13
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Meg-Ball Attachment System, Meg-Loc Abutment, Meg-Magnet Abutment is a medical device manufactured by Megagen Implant Co., Ltd.. It received FDA 510(k) clearance on 2020-02-13 under approval number K192614. 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 Meg-Ball Attachment System, Meg-Loc Abutment, Meg-Magnet Abutment?

Meg-Ball Attachment System, Meg-Loc Abutment, Meg-Magnet Abutment is a medical device that received FDA 510(k) clearance on 2020-02-13. It is manufactured by Megagen Implant Co., Ltd.. The 510(k) number is K192614.

When was Meg-Ball Attachment System, Meg-Loc Abutment, Meg-Magnet Abutment approved by the FDA?

Meg-Ball Attachment System, Meg-Loc Abutment, Meg-Magnet Abutment received FDA 510(k) clearance on 2020-02-13, under approval number K192614.

What company makes Meg-Ball Attachment System, Meg-Loc Abutment, Meg-Magnet Abutment?

Meg-Ball Attachment System, Meg-Loc Abutment, Meg-Magnet Abutment is manufactured by Megagen Implant Co., Ltd..

What is the FDA product code for Meg-Ball Attachment System, Meg-Loc Abutment, Meg-Magnet Abutment?

The FDA product code for Meg-Ball Attachment System, Meg-Loc Abutment, Meg-Magnet Abutment is NHA.

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Other Devices by Megagen Implant Co., Ltd.

K192347ST Internal Implant System K182448AnyRidge Octa 1 Implant System K191127Advanced Intermezzo Implant System K190096R2GATE K203808Multi-unit Abutment, Multi-unit Angled Abutment K203554AnyOne External Implant System

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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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