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FDA 510(k)

JDentalCare Dental Implant System: JDEvolution; JDEvolution plus; JDIcon; JDIcon plus

K-Number: K233896 · 2024-08-16

ApplicantJdentalcare Srl
Decision Date2024-08-16
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

JDentalCare Dental Implant System: JDEvolution; JDEvolution plus; JDIcon; JDIcon plus is a medical device manufactured by Jdentalcare Srl. It received FDA 510(k) clearance on 2024-08-16 under approval number K233896. 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 JDentalCare Dental Implant System: JDEvolution; JDEvolution plus; JDIcon; JDIcon plus?

JDentalCare Dental Implant System: JDEvolution; JDEvolution plus; JDIcon; JDIcon plus is a medical device that received FDA 510(k) clearance on 2024-08-16. It is manufactured by Jdentalcare Srl. The 510(k) number is K233896.

When was JDentalCare Dental Implant System: JDEvolution; JDEvolution plus; JDIcon; JDIcon plus approved by the FDA?

JDentalCare Dental Implant System: JDEvolution; JDEvolution plus; JDIcon; JDIcon plus received FDA 510(k) clearance on 2024-08-16, under approval number K233896.

What company makes JDentalCare Dental Implant System: JDEvolution; JDEvolution plus; JDIcon; JDIcon plus?

JDentalCare Dental Implant System: JDEvolution; JDEvolution plus; JDIcon; JDIcon plus is manufactured by Jdentalcare Srl.

What is the FDA product code for JDentalCare Dental Implant System: JDEvolution; JDEvolution plus; JDIcon; JDIcon plus?

The FDA product code for JDentalCare Dental Implant System: JDEvolution; JDEvolution plus; JDIcon; JDIcon plus 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)

Other Devices by Jdentalcare Srl

K182081JDentalCare Implant System JDIcon K240143JDZygoma dental implants K251148JDEvolution Plus L and JDEvolution Plus LE

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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