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FDA 510(k)

Noris Medical Dental Implants System - Cortical

K-Number: K210852 · 2022-06-24

ApplicantNoris Medical , Ltd.
Decision Date2022-06-24
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Noris Medical Dental Implants System - Cortical is a medical device manufactured by Noris Medical , Ltd.. It received FDA 510(k) clearance on 2022-06-24 under approval number K210852. 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 Noris Medical Dental Implants System - Cortical?

Noris Medical Dental Implants System - Cortical is a medical device that received FDA 510(k) clearance on 2022-06-24. It is manufactured by Noris Medical , Ltd.. The 510(k) number is K210852.

When was Noris Medical Dental Implants System - Cortical approved by the FDA?

Noris Medical Dental Implants System - Cortical received FDA 510(k) clearance on 2022-06-24, under approval number K210852.

What company makes Noris Medical Dental Implants System - Cortical?

Noris Medical Dental Implants System - Cortical is manufactured by Noris Medical , Ltd..

What is the FDA product code for Noris Medical Dental Implants System - Cortical?

The FDA product code for Noris Medical Dental Implants System - Cortical is DZE.

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Related PubMed Literature

PMID: 42181028 Systematic biocompatibility assessment of 4-µm surface silicone implants. Biomaterials and biosystems (2026) PMID: 42175114 Make Open Source Compliant: Validation in Non-Interventional Clinical Studies. Studies in health technology and informatics (2026) PMID: 42174947 Aligning AI-Native 6G Healthcare Systems with EU Ethical and Legal Frameworks. Studies in health technology and informatics (2026) PMID: 42173476 Feasibility of applying the Orthopaedic Data Evaluation Panel (ODEP) shoulder criteria for implants used in a United States-based integrated healthcare system. Journal of shoulder and elbow surgery (2026)

Other Devices by Noris Medical , Ltd.

K153043Noris Medical MBI Dental Implant System K151909Noris Medical Zygomatic Dental Implant System K162308Noris Medical MBI-2mm Dental Implant System K210356Noris Medical Dental Implants System K240202Conical Platform Dental Implants System K241462LONGY Implant and LONGY-N Implant

View all 7 devices →

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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