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FDA 510(k)

MagDen Dental Implant System

K-Number: K162867 · 2017-07-26

Decision Date2017-07-26
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

MagDen Dental Implant System is the device name listed in this FDA 510(k) record. The listed applicant is Shinhung Mst Co., Ltd.. It received FDA 510(k) clearance on 2017-07-26 under 510(k) number K162867. 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 MagDen Dental Implant System?

MagDen Dental Implant System is a medical device that received FDA 510(k) clearance on 2017-07-26. The listed applicant is Shinhung Mst Co., Ltd.. The 510(k) number is K162867.

When did MagDen Dental Implant System receive FDA 510(k) clearance?

MagDen Dental Implant System received FDA 510(k) clearance on 2017-07-26, under 510(k) number K162867.

Who is the listed applicant for MagDen Dental Implant System?

The FDA 510(k) record lists Shinhung Mst Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MagDen Dental Implant System?

The FDA product code for MagDen Dental Implant System is DZE.

Other records listing Shinhung Mst Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Related Devices (Code: DZE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Official Source

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