FDA 510(k)

W Zirconia Implants

K-Number: K192053 · 2019-10-29

Decision Date2019-10-29

Product CodeDZE

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

W Zirconia Implants is a medical device manufactured by Tav Medical , Ltd.. It received FDA 510(k) clearance on 2019-10-29 under approval number K192053. 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 W Zirconia Implants?

W Zirconia Implants is a medical device that received FDA 510(k) clearance on 2019-10-29. It is manufactured by Tav Medical , Ltd.. The 510(k) number is K192053.

When was W Zirconia Implants approved by the FDA?

W Zirconia Implants received FDA 510(k) clearance on 2019-10-29, under approval number K192053.

What company makes W Zirconia Implants?

W Zirconia Implants is manufactured by Tav Medical , Ltd..

What is the FDA product code for W Zirconia Implants?

The FDA product code for W Zirconia Implants is DZE.

Related Clinical Trials

NCT06012071 Two-piece Zirconia Implants With Two Various Platforms RECRUITING NCT03908177 Comparison of Clinical Performance and Safety of Zirconia vs. Titanium Implants: a Multi-national RCT. COMPLETED NCT04695899 Zirconia Implants for Replacement of a Single Tooth ACTIVE_NOT_RECRUITING

Other Devices by Tav Medical , Ltd.

K172668W Zirconia Implants K170131TAV Medical Dental Implants System

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

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