FDA 510(k)

IS-III HActive Fixture

K-Number: K173938 · 2018-05-24

Decision Date2018-05-24

Product CodeDZE

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

IS-III HActive Fixture is a medical device manufactured by Neobiotech Co., Ltd.. It received FDA 510(k) clearance on 2018-05-24 under approval number K173938. 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 IS-III HActive Fixture?

IS-III HActive Fixture is a medical device that received FDA 510(k) clearance on 2018-05-24. It is manufactured by Neobiotech Co., Ltd.. The 510(k) number is K173938.

When was IS-III HActive Fixture approved by the FDA?

IS-III HActive Fixture received FDA 510(k) clearance on 2018-05-24, under approval number K173938.

What company makes IS-III HActive Fixture?

IS-III HActive Fixture is manufactured by Neobiotech Co., Ltd..

What is the FDA product code for IS-III HActive Fixture?

The FDA product code for IS-III HActive Fixture is DZE.

Other Devices by Neobiotech Co., Ltd.

K160991Neo GBR System K181137IT-III active System K181138IS-III active System K181178S-mini active Fixture K190849IS-III active System_S-narrow Type K210903IS Multi Unit Abutment System

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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.