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FDA 510(k)

QZA and RS Dental Implant Systems

K-Number: K163640 · 2017-05-03

ApplicantTrinon Titanium GmbH
Decision Date2017-05-03
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

QZA and RS Dental Implant Systems is the device name listed in this FDA 510(k) record. The listed applicant is Trinon Titanium GmbH. It received FDA 510(k) clearance on 2017-05-03 under 510(k) number K163640. 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 QZA and RS Dental Implant Systems?

QZA and RS Dental Implant Systems is a medical device that received FDA 510(k) clearance on 2017-05-03. The listed applicant is Trinon Titanium GmbH. The 510(k) number is K163640.

When did QZA and RS Dental Implant Systems receive FDA 510(k) clearance?

QZA and RS Dental Implant Systems received FDA 510(k) clearance on 2017-05-03, under 510(k) number K163640.

Who is the listed applicant for QZA and RS Dental Implant Systems?

The FDA 510(k) record lists Trinon Titanium GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for QZA and RS Dental Implant Systems?

The FDA product code for QZA and RS Dental Implant Systems is DZE.

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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