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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 the device name listed in this FDA 510(k) record. The listed applicant is T-Plus Implant Tech. Co., Ltd.. It received FDA 510(k) clearance on 2016-06-07 under 510(k) 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. The listed applicant is T-Plus Implant Tech. Co., Ltd.. The 510(k) number is K152786.

When did A Plus Internal Fixture System receive FDA 510(k) clearance?

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

Who is the listed applicant for A Plus Internal Fixture System?

The FDA 510(k) record lists T-Plus Implant Tech. Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing T-Plus Implant Tech. Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K190919ST Internal Implant SystemK152787ST Internal Fixture System

Related Devices (Code: DZE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251188UNIQA® Dental Implants SystemUniqa Dental, Ltd.K251232MegaGen Zygoma Dental Implant SystemMegagen Implant Co., Ltd.K250806Dental Implant SystemA.B. Dental Devices , Ltd.K260006INOSS SystemInosys, Inc.K252731Promimic ZrP Surface Dental Implant; Promimic ZrP + HAnano Surface Dental ImplantPromimic ABK252031Adin Long Dental Implant SystemAdin Dental Implant Systems , 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.

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