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FDA 510(k)

A Plus Internal Fixture System

K-Number: K152786 · 2016-06-07

ApplicantT-Plus Implant Tech. Co., Ltd.
Decision Date2016-06-07
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

A Plus Internal Fixture System is a medical device manufactured by T-Plus Implant Tech. Co., Ltd.. It received FDA 510(k) clearance on 2016-06-07 under approval number K152786. 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 A Plus Internal Fixture System?

A Plus Internal Fixture System is a medical device that received FDA 510(k) clearance on 2016-06-07. It is manufactured by T-Plus Implant Tech. Co., Ltd.. The 510(k) number is K152786.

When was A Plus Internal Fixture System approved by the FDA?

A Plus Internal Fixture System received FDA 510(k) clearance on 2016-06-07, under approval number K152786.

What company makes A Plus Internal Fixture System?

A Plus Internal Fixture System is manufactured by T-Plus Implant Tech. Co., Ltd..

What is the FDA product code for A Plus Internal Fixture System?

The FDA product code for A Plus Internal Fixture System is DZE.

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Other Devices by T-Plus Implant Tech. Co., Ltd.

K152787ST Internal Fixture System K190919ST Internal Implant 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

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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