Data / Medical devices / Israel / Noris Medical Ltd.

Noris Medical Ltd.: FDA-registered device maker in Nesher Haifa, Israel, 8 510(k) clearances

Name: Noris Medical Ltd. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Noris Medical Ltd. is registered with the FDA (registration 3011390931) in Nesher Haifa, Israel. It lists 4 device types. The FDA files 8 510(k) clearances under its listings, the newest dated February 11, 2025. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3011390931
Address: 8 Hataasia St., Nesher Haifa, Israel, 3688808
Owner or operator: Noris Medical Ltd. (10048677)
Roles: Complaint file establishment, Manufacturer
First device listed: February 10, 2015
Registered through: 2026

Devices it lists

Device	Product code	Class	Role	Source
Abutment, Implant, Dental, Endosseous	NHA	2	Manufacturer	accessdata.fda.gov
Accessories, Implant, Dental, Endosseous	NDP	1	Complaint file establishment, Manufacturer	accessdata.fda.gov
Drill, Dental, Intraoral	DZA	1	Manufacturer	accessdata.fda.gov
Implant, Endosseous, Root-Form	DZE	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
February 11, 2025	K241462	LONGY Implant and LONGY-N Implant	DZE	Substantially Equivalent	Noris Medical , Ltd.	accessdata.fda.gov
June 6, 2024	K240202	Conical Platform Dental Implants System	DZE	Substantially Equivalent	Noris Medical , Ltd.	accessdata.fda.gov
June 24, 2022	K210852	Noris Medical Dental Implants System - Cortical	DZE	Substantially Equivalent	Noris Medical , Ltd.	accessdata.fda.gov
February 4, 2022	K210356	Noris Medical Dental Implants System	NHA	Substantially Equivalent	Noris Medical , Ltd.	accessdata.fda.gov
March 17, 2017	K162308	Noris Medical MBI-2mm Dental Implant System	DZE	Substantially Equivalent	Noris Medical , Ltd.	accessdata.fda.gov
April 11, 2016	K153043	Noris Medical MBI Dental Implant System	DZE	Substantially Equivalent	Noris Medical , Ltd.	accessdata.fda.gov
April 8, 2016	K151909	Noris Medical Zygomatic Dental Implant System	DZE	Substantially Equivalent	Noris Medical , Ltd.	accessdata.fda.gov
December 19, 2014	K140440	NORIS MEDICAL DENTAL IMPLANTS SYSTEM	DZE	Substantially Equivalent	Noris Medical , Ltd.	accessdata.fda.gov

Compare with other makers

Updated February 11, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.