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FDA 510(k)

Genesis ACTIVE Implant System

K-Number: K223814 · 2023-05-25

ApplicantKeystone Dental, Inc.
Decision Date2023-05-25
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Genesis ACTIVE Implant System is the device name listed in this FDA 510(k) record. The listed applicant is Keystone Dental, Inc.. It received FDA 510(k) clearance on 2023-05-25 under 510(k) number K223814. 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 Genesis ACTIVE Implant System?

Genesis ACTIVE Implant System is a medical device that received FDA 510(k) clearance on 2023-05-25. The listed applicant is Keystone Dental, Inc.. The 510(k) number is K223814.

When did Genesis ACTIVE Implant System receive FDA 510(k) clearance?

Genesis ACTIVE Implant System received FDA 510(k) clearance on 2023-05-25, under 510(k) number K223814.

Who is the listed applicant for Genesis ACTIVE Implant System?

The FDA 510(k) record lists Keystone Dental, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Genesis ACTIVE Implant System?

The FDA product code for Genesis ACTIVE Implant System is DZE.

Other records listing Keystone Dental, Inc. 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.

K240966Prima Plus Conical Implant SystemK221381KDG AbutmentsK201334Keystone Dental XL Dental Implant 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

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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