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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 a medical device manufactured by Keystone Dental, Inc.. It received FDA 510(k) clearance on 2023-05-25 under approval 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. It is manufactured by Keystone Dental, Inc.. The 510(k) number is K223814.

When was Genesis ACTIVE Implant System approved by the FDA?

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

What company makes Genesis ACTIVE Implant System?

Genesis ACTIVE Implant System is manufactured by Keystone Dental, Inc..

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

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

Related Clinical Trials

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Related PubMed Literature

PMID: 41966145 From Registry to Reality: Opportunities to Enhance Post-market Surveillance of High-Risk Medical Devices Comment on "Quality and Utility of European Cardiovascular and Orthopaedic Registries for the Regulatory Evaluation of Medical Device Safety and Performance Across the Implant Lifecycle: A Systematic Review". International journal of health policy and management (2025) PMID: 35685299 Multicenter, Double-Blinded, Randomized, Active-Sham Controlled Clinical Study Design to Assess the Safety and Effectiveness of a Novel High Frequency Electric Nerve Block System in the Treatment of Post-Amputation Pain (The QUEST Study). Journal of pain research (2022)

Other Devices by Keystone Dental, Inc.

K201334Keystone Dental XL Dental Implant System K221381KDG Abutments K240966Prima Plus Conical Implant System

Related Devices (Code: DZE)

K160475Ritter Dental Implant SystemRitter Implants GmbH & Co. KG K161244s-Clean OneQ-SL Narrow Implant SystemDentis Co., Ltd. K163043Zeramex P6 Dental Implant SystemDentalpoint AG K161497Dental Implants and AbutmentsDitron Precision, Ltd. K153332ETIII SA Fixture System (O3.2mm)Hiossen, Inc. K151970KJ Mini Implant SystemKj Meditech Co., 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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