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FDA 510(k)

Cortex Dental Implant System

K-Number: K163385 · 2017-08-29

Decision Date2017-08-29
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Cortex Dental Implant System is the device name listed in this FDA 510(k) record. The listed applicant is Cortex Dental Implants Industries , Ltd.. It received FDA 510(k) clearance on 2017-08-29 under 510(k) number K163385. 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 Cortex Dental Implant System?

Cortex Dental Implant System is a medical device that received FDA 510(k) clearance on 2017-08-29. The listed applicant is Cortex Dental Implants Industries , Ltd.. The 510(k) number is K163385.

When did Cortex Dental Implant System receive FDA 510(k) clearance?

Cortex Dental Implant System received FDA 510(k) clearance on 2017-08-29, under 510(k) number K163385.

Who is the listed applicant for Cortex Dental Implant System?

The FDA 510(k) record lists Cortex Dental Implants Industries , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Cortex Dental Implant System?

The FDA product code for Cortex Dental Implant System is DZE.

Other records listing Cortex Dental Implants Industries , 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.

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.

Official Source

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