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FDA 510(k)

Noris Medical Dental Implants System

K-Number: K210356 · 2022-02-04

ApplicantNoris Medical , Ltd.
Decision Date2022-02-04
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Noris Medical Dental Implants System is a medical device manufactured by Noris Medical , Ltd.. It received FDA 510(k) clearance on 2022-02-04 under approval number K210356. The device is classified under product code NHA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Noris Medical Dental Implants System?

Noris Medical Dental Implants System is a medical device that received FDA 510(k) clearance on 2022-02-04. It is manufactured by Noris Medical , Ltd.. The 510(k) number is K210356.

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

Noris Medical Dental Implants System received FDA 510(k) clearance on 2022-02-04, under approval number K210356.

What company makes Noris Medical Dental Implants System?

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

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

The FDA product code for Noris Medical Dental Implants System is NHA.

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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 K210852Noris Medical Dental Implants System - Cortical K240202Conical Platform Dental Implants System K241462LONGY Implant and LONGY-N Implant

View all 7 devices →

Related Devices (Code: NHA)

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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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