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FDA 510(k)

Z5-BL

K-Number: K200386 · 2020-10-14

ApplicantZ-Systems AG
Decision Date2020-10-14
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Z5-BL is a medical device manufactured by Z-Systems AG. It received FDA 510(k) clearance on 2020-10-14 under approval number K200386. 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 Z5-BL?

Z5-BL is a medical device that received FDA 510(k) clearance on 2020-10-14. It is manufactured by Z-Systems AG. The 510(k) number is K200386.

When was Z5-BL approved by the FDA?

Z5-BL received FDA 510(k) clearance on 2020-10-14, under approval number K200386.

What company makes Z5-BL?

Z5-BL is manufactured by Z-Systems AG.

What is the FDA product code for Z5-BL?

The FDA product code for Z5-BL is DZE.

Other Devices by Z-Systems AG

K201712Z5-TL K190243Z5-BL K201878ST-Z5

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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