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FDA 510(k)

ST Internal Fixture System

K-Number: K152787 · 2016-07-22

ApplicantT-Plus Implant Tech. Co., Ltd.
Decision Date2016-07-22
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ST 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 2016-07-22 under 510(k) number K152787. 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 ST Internal Fixture System?

ST Internal Fixture System is a medical device that received FDA 510(k) clearance on 2016-07-22. The listed applicant is T-Plus Implant Tech. Co., Ltd.. The 510(k) number is K152787.

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

ST Internal Fixture System received FDA 510(k) clearance on 2016-07-22, under 510(k) number K152787.

Who is the listed applicant for ST 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 ST Internal Fixture System?

The FDA product code for ST 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 SystemK152786A Plus 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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