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FDA 510(k)

IS-III active System

K-Number: K181138 · 2018-10-03

ApplicantNeobiotech Co., Ltd.
Decision Date2018-10-03
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

IS-III active System is a medical device manufactured by Neobiotech Co., Ltd.. It received FDA 510(k) clearance on 2018-10-03 under approval number K181138. 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 active System?

IS-III active System is a medical device that received FDA 510(k) clearance on 2018-10-03. It is manufactured by Neobiotech Co., Ltd.. The 510(k) number is K181138.

When was IS-III active System approved by the FDA?

IS-III active System received FDA 510(k) clearance on 2018-10-03, under approval number K181138.

What company makes IS-III active System?

IS-III active System is manufactured by Neobiotech Co., Ltd..

What is the FDA product code for IS-III active System?

The FDA product code for IS-III active System is DZE.

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Other Devices by Neobiotech Co., Ltd.

K160991Neo GBR System K181137IT-III active System K181178S-mini active Fixture K173938IS-III HActive Fixture K190849IS-III active System_S-narrow Type K210903IS Multi Unit Abutment System

View all 9 devices →

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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