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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 the device name listed in this FDA 510(k) record. The listed applicant is Jdentalcare Srl. It received FDA 510(k) clearance on 2024-08-16 under 510(k) 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. The listed applicant is Jdentalcare Srl. The 510(k) number is K233896.

When did JDentalCare Dental Implant System: JDEvolution; JDEvolution plus; JDIcon; JDIcon plus receive FDA 510(k) clearance?

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

Who is the listed applicant for JDentalCare Dental Implant System: JDEvolution; JDEvolution plus; JDIcon; JDIcon plus?

The FDA 510(k) record lists Jdentalcare Srl as the applicant. This does not by itself establish the device manufacturer.

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

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.

NCT07091448Biotivity A-C Membrane Socket Preservation StudyNOT_YET_RECRUITINGNCT07744776Effect of Implant Macro-Design and Surface Treatment on Insertion Torque and Early Implant Stability Quotient (ISQ)RECRUITINGNCT07763431Home-Use Dual-Light Antibacterial Photodynamic Therapy for Peri-Implant Mucositis in Full-Arch Implant ProsthesesNOT_YET_RECRUITING

Other records listing Jdentalcare Srl 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.

K251148JDEvolution Plus L and JDEvolution Plus LEK240143JDZygoma dental implantsK182081JDentalCare Implant System JDIcon

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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