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FDA 510(k)

Noris Medical Zygomatic Dental Implant System

K-Number: K151909 · 2016-04-08

ApplicantNoris Medical , Ltd.
Decision Date2016-04-08
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Noris Medical Zygomatic Dental Implant System is the device name listed in this FDA 510(k) record. The listed applicant is Noris Medical , Ltd.. It received FDA 510(k) clearance on 2016-04-08 under 510(k) number K151909. 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 Zygomatic Dental Implant System?

Noris Medical Zygomatic Dental Implant System is a medical device that received FDA 510(k) clearance on 2016-04-08. The listed applicant is Noris Medical , Ltd.. The 510(k) number is K151909.

When did Noris Medical Zygomatic Dental Implant System receive FDA 510(k) clearance?

Noris Medical Zygomatic Dental Implant System received FDA 510(k) clearance on 2016-04-08, under 510(k) number K151909.

Who is the listed applicant for Noris Medical Zygomatic Dental Implant System?

The FDA 510(k) record lists Noris Medical , Ltd. as the applicant. This does not by itself establish the device manufacturer.

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

The FDA product code for Noris Medical Zygomatic Dental Implant System 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.

NCT07551024Evaluation of Zygomatic Implant Placement Accuracy Using Fully Metallic vs Resin-based Static Surgical Guides in Severely Atrophic MaxillaRECRUITING

Other records listing Noris Medical , Ltd. 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.

K241462LONGY Implant and LONGY-N ImplantK240202Conical Platform Dental Implants SystemK210852Noris Medical Dental Implants System - CorticalK210356Noris Medical Dental Implants SystemK162308Noris Medical MBI-2mm Dental Implant SystemK153043Noris Medical MBI Dental Implant System

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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

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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