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FDA 510(k)

Microdent Ektos Implant System

K-Number: K153650 · 2016-05-20

ApplicantImplants Microdent System S.L
Decision Date2016-05-20
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Microdent Ektos Implant System is the device name listed in this FDA 510(k) record. The listed applicant is Implants Microdent System S.L. It received FDA 510(k) clearance on 2016-05-20 under 510(k) number K153650. 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 Microdent Ektos Implant System?

Microdent Ektos Implant System is a medical device that received FDA 510(k) clearance on 2016-05-20. The listed applicant is Implants Microdent System S.L. The 510(k) number is K153650.

When did Microdent Ektos Implant System receive FDA 510(k) clearance?

Microdent Ektos Implant System received FDA 510(k) clearance on 2016-05-20, under 510(k) number K153650.

Who is the listed applicant for Microdent Ektos Implant System?

The FDA 510(k) record lists Implants Microdent System S.L as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Microdent Ektos Implant System?

The FDA product code for Microdent Ektos Implant 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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