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FDA 510(k)

LONGY Implant and LONGY-N Implant

K-Number: K241462 · 2025-02-11

ApplicantNoris Medical , Ltd.
Decision Date2025-02-11
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

LONGY Implant and LONGY-N Implant 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 2025-02-11 under 510(k) number K241462. 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 LONGY Implant and LONGY-N Implant?

LONGY Implant and LONGY-N Implant is a medical device that received FDA 510(k) clearance on 2025-02-11. The listed applicant is Noris Medical , Ltd.. The 510(k) number is K241462.

When did LONGY Implant and LONGY-N Implant receive FDA 510(k) clearance?

LONGY Implant and LONGY-N Implant received FDA 510(k) clearance on 2025-02-11, under 510(k) number K241462.

Who is the listed applicant for LONGY Implant and LONGY-N Implant?

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 LONGY Implant and LONGY-N Implant?

The FDA product code for LONGY Implant and LONGY-N Implant is DZE.

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.

K240202Conical Platform Dental Implants SystemK210852Noris Medical Dental Implants System - CorticalK210356Noris Medical Dental Implants SystemK162308Noris Medical MBI-2mm Dental Implant SystemK153043Noris Medical MBI Dental Implant SystemK151909Noris Medical Zygomatic 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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