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FDA 510(k)

ALFA GATE Dental Implants System

K-Number: K182143 · 2019-10-03

ApplicantAlfa Gate Mazen, Ltd.
Decision Date2019-10-03
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ALFA GATE Dental Implants System is the device name listed in this FDA 510(k) record. The listed applicant is Alfa Gate Mazen, Ltd.. It received FDA 510(k) clearance on 2019-10-03 under 510(k) number K182143. 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 ALFA GATE Dental Implants System?

ALFA GATE Dental Implants System is a medical device that received FDA 510(k) clearance on 2019-10-03. The listed applicant is Alfa Gate Mazen, Ltd.. The 510(k) number is K182143.

When did ALFA GATE Dental Implants System receive FDA 510(k) clearance?

ALFA GATE Dental Implants System received FDA 510(k) clearance on 2019-10-03, under 510(k) number K182143.

Who is the listed applicant for ALFA GATE Dental Implants System?

The FDA 510(k) record lists Alfa Gate Mazen, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ALFA GATE Dental Implants System?

The FDA product code for ALFA GATE Dental Implants System 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

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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