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FDA 510(k)

Prima Plus Conical Implant System

K-Number: K240966 · 2024-07-09

ApplicantKeystone Dental, Inc.
Decision Date2024-07-09
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Prima Plus Conical Implant System is a medical device manufactured by Keystone Dental, Inc.. It received FDA 510(k) clearance on 2024-07-09 under approval number K240966. 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 Prima Plus Conical Implant System?

Prima Plus Conical Implant System is a medical device that received FDA 510(k) clearance on 2024-07-09. It is manufactured by Keystone Dental, Inc.. The 510(k) number is K240966.

When was Prima Plus Conical Implant System approved by the FDA?

Prima Plus Conical Implant System received FDA 510(k) clearance on 2024-07-09, under approval number K240966.

What company makes Prima Plus Conical Implant System?

Prima Plus Conical Implant System is manufactured by Keystone Dental, Inc..

What is the FDA product code for Prima Plus Conical Implant System?

The FDA product code for Prima Plus Conical Implant System is DZE.

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Related PubMed Literature

PMID: 39892748 Long-term Safety and Performance of a Suprachoroidal Pressure Sensor System: Results of the EYEMATE-SC Trial Follow-up Study. Ophthalmology (2025) 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: 39726899 How to improve the mechanical safety of a novel spinal implant while saving costs and time. JOR spine (2024)

Other Devices by Keystone Dental, Inc.

K201334Keystone Dental XL Dental Implant System K221381KDG Abutments K223814Genesis ACTIVE 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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