The Noris LONGY and LONGY-N implants are indicated for splinted restorations in the maxilla, utilizing a minimum of two implants to support fixed or removable prosthetic devices with partially or fully edentulous upper jaws, and may be suitable for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

The procedure can be accomplished in a one-stage or two-stage surgical operation.

Device Description

The subject dental implant devices are single use devices, provided sterile by Gamma Radiation, made of Titanium alloy Ti-6Al-4V ELI (ASTM F136). The LONGY Implants and LONGY-N Implants bare internal hex connection, diameters of 3.75 and 4.0mm and lengths of 18, 20, 22 and 25 mm. The Noris LONGY and LONGY-N implants are indicated for splinted restorations in the maxilla, utilizing a minimum of two implants to support fixed or removable prosthetic devices in patients with partially or fully edentulous upper jaws, and may be suitable for immediate loading when good primary stability is achieved. The procedure can be accomplished in a one-stage surgical operation. All implants are appropriate for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

LONGY and LONGY-N dental implants are compatible with FDA cleared Noris Medical Ltd. Internal Hex platform abutments and superstructures only intended for multiple-unit loading, provided that they do not exceed an angulation of 30° (≤30).

AI/ML Overview

The provided text is a 510(k) Premarket Notification from Noris Medical Ltd. for their LONGY Implant and LONGY-N Implant. It primarily focuses on demonstrating substantial equivalence to legally marketed predicate devices rather than proving a device meets specific acceptance criteria through a study involving AI or human reader performance.

Therefore, the document does not contain the information required to answer the prompt's request for acceptance criteria and a study proving device performance against those criteria, especially in the context of AI assistance or human reader improvement.

The document details the following:

Device Name: LONGY Implant and LONGY-N Implant
Regulation Number/Name: 21 CFR 872.3640 (Endosseous Dental Implant)
Regulatory Class: Class II
Product Code: DZE
Indications for Use: Splinted restorations in the maxilla, utilizing a minimum of two implants to support fixed or removable prosthetic devices in patients with partially or fully edentulous upper jaws, suitable for immediate loading when good primary stability is achieved and with appropriate occlusal loading. Can be accomplished in a one-stage or two-stage surgical operation.
Predicate Devices: Neodent Implant System - GM Helix LG ® (K190958 - Primary), Noris Medical Ltd. - TUFF (K140440 - Reference), Neodent Implant System - Zygoma GM (K190718 - Reference), Noris Medical Ltd. - Zygomatic Implants (K151909 - Reference), Noris Medical Ltd. - MBI Dental Implant System (K153043 - Reference).
Device Description: Single-use, sterile (Gamma Radiation), made of Titanium alloy Ti-6Al-4V ELI (ASTM F136), internal hex connection, diameters of 3.75 and 4.0mm, lengths of 18, 20, 22, and 25 mm.
Performance Data: Fatigue tests per ISO 14801, biocompatibility, sterilization validation, shelf-life testing, mechanical testing, and MRI review. These tests are to demonstrate substantial equivalence, not to establish performance against specific clinical acceptance criteria in a user-performance or AI-assisted context.

Missing Information (as per the prompt's requirements):

A table of acceptance criteria and the reported device performance: Not provided in the context of clinical endpoints or user performance. The performance data discussed (fatigue, biocompatibility, etc.) are for device safety and mechanical integrity, not for clinical diagnostic or treatment performance against specific numerical acceptance criteria.
Sample size used for the test set and the data provenance: No test set is described for evaluating AI or human reader performance.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no AI/human reader study is described.
Adjudication method for the test set: Not applicable.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: Not mentioned.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not mentioned. This document is about a physical dental implant, not AI software.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to the presented data (which is about implant mechanical and material properties).
The sample size for the training set: Not applicable (no AI/machine learning model discussed).
How the ground truth for the training set was established: Not applicable.

In summary, the provided document is a regulatory submission for a dental implant, focusing on its physical and material properties to demonstrate substantial equivalence for market clearance. It does not contain information related to AI or human-in-the-loop studies, nor does it define acceptance criteria in the manner requested by the prompt for such studies.

Summary

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

Noris Medical Ltd. Biatrina Shidlovsky Senior Regulatory Affairs Expert 8 Hataasia St. Nesher, 3688808 ISRAEL

February 11, 2025

Re: K241462

Trade/Device Name: LONGY Implant and LONGY-N Implant Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE Dated: December 29, 2024 Received: January 13, 2025

Dear Biatrina Shidlovsky:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products: and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

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For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Andrew I. Steen -S

Andrew I. Steen Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K241462

Device Name LONGY Implant and LONGY-N Implant

Indications for Use (Describe)

The procedure can be accomplished in a one-stage or two-stage surgical operation.

Type of Use (Select one or both, as applicable)

☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/4/Picture/1 description: The image is a logo for Noris Medical Dental Implant Solutions. The logo consists of a red abstract shape on the left, followed by the text "NORIS Medical" in gray, with the registered trademark symbol. Below the company name, the text "Dental Implant Solutions" is written in a smaller, lighter gray font.

510k Summary

SUBMITTER l.

Noris Medical Ltd. 8 Hataasia St. 3688808 Nesher, Israel

Phone: 972-73-7964477

Contact Person: Biatrina Shidlovsky Date Prepared: Feb 11, 2025

II. DEVICE

Name of Device: LONGY Implant and LONGY-N Implant Common or Usual Name: Long Dental Implants System Classification Name: Endosseous dental implant (21 CFR 872.3640) Regulatory Class: II Product Code: DZE

III. PREDICATE DEVICE

Neodent Implant System- GM Helix LG ® (K190958 Primary Predicate) Noris Medical Ltd. - TUFF (K140440 Reference Device) Neodent Implant System- Zygoma GM (K190718 Reference Device) Noris Medical Ltd. - Zygomatic Implants (K151909 Reference Device) Noris Medical Ltd. - MBI Dental Implant System (K153043 Reference Device)

IV. DEVICE DESCRIPTION

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Image /page/5/Picture/0 description: The image shows the logo for Noris Medical Dental Implant Solutions. The logo consists of a red abstract shape on the left, followed by the text "NORIS Medical" in gray, with a registered trademark symbol. Below that, the text "Dental Implant Solutions" is written in a smaller, lighter gray font. The text "INDICATION FOR USE" is written in bold, underlined letters, and the letter "V." is written on the bottom left.

The Noris LONGY and LONGY-N implants are indicated for splinted restorations in the maxilla, utilizing a minimum of two implants to support fixed or removable prosthetic devices in patients with partially or fully edentulous upper jaws, and may be suitable for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

The procedure can be accomplished in a one-stage or two-stage surgical operation.

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Image /page/6/Picture/0 description: The image shows the logo for Noris Medical, a company that provides dental implant solutions. The logo consists of a red abstract shape on the left and the words "NORIS Medical" in gray on the right. Below the company name, the words "Dental Implant Solutions" are written in a smaller font, also in gray. The logo is simple and modern, and it conveys the company's focus on medical and dental solutions.

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS VI.

	SUBJECT DEVICE	SUBJECT DEVICE	PRIMARY PREDICATE	REFERENCE PREDICATE	REFERENCE PREDICATE
Device	LONGY Implant	LONGY-N Implant	GM Helix LG (K190958)	Tuff (K140440)	Zygoma GM (K190718)
	Noris Medical Ltd.	Noris Medical Ltd.	Neodent Implant System	Noris Medical Ltd.	Neodent Implant System
Design Description	Threaded root-form implant to beused with matching abutments.	Threaded root-form implant with 2flat surfaces to be used withmatching abutments.	Threaded root-form implant with internalGM Morse taper connection with internalhex.	Threaded root-form implant to beused with matching abutments.	Threaded root-form implant to beused with matching abutments,made of Titanium grade 4.With 2 flat surfaces.
Indication for Use	The Noris LONGY and LONGY-Nimplants are indicated for splintedrestorations in the maxilla, utilizinga minimum of two implants tosupport fixed or removableprosthetic devices in patients withpartially or fully edentulous upperjaws, and may be suitable forimmediate loading when goodprimary stability is achieved andwith appropriate occlusal loading.The procedure can beaccomplished in a one-stage ortwo-stage surgical operation.	The Noris LONGY and LONGY-Nimplants are indicated for splintedrestorations in the maxilla, utilizing aminimum of two implants to supportfixed or removable prostheticdevices in patients with partially orfully edentulous upper jaws, andmay be suitable for immediateloading when good primary stabilityis achieved.The procedure can be accomplishedin a one-stage or two-stage surgicaloperation.	The Neodent Implant System is intendedto be surgically placed in the bone of theupper or lower jaw to provide support forprosthetic devices, such as artificial teeth,to restore chewing function. It may beused with single- stage or two-stageprocedures, for single or multiple unitrestorations, and may be loadedimmediately when good primary stability isachieved and with appropriate occlusalloading. The Neodent GM Helix LGimplants can be placed bicortically incases of reduced bone density. TheNeodent GM Helix LG implants are onlyindicated for multiple unit restorations insplinted applications that utilize at leasttwo implants.	Noris Medical Ltd Dental ImplantsSystem is intended to replacemissing tooth/teeth in either jaw forsupporting prosthetic devices thatmay aid in restoring the patient'schewing function. The procedurecan be accomplished in a one-stage or two-stage surgicaloperation. All implants areappropriate for immediate loadingwhen good primary stability isachieved and with appropriateocclusal loading.	Zygomatic Implants are indicatedfor surgical installation in thezygoma region, in cases of severejaw resorption, in order to restorepatient esthetics and chewingfunction. Zygomatic Implants arerecommended for the posterior(pre-molar/molar) region, oneimplant on each side, with at leasttwo standard dental implants in theanterior region to support a fixedrestoration. Zygomatic Implantsmay be loaded immediately whengood primary stability is achievedand with appropriate occlusalloading
Type	Bone level Implant	Bone level Implant	Bone level Implant	Bone level Implant	Bone level Implant
	SUBJECT DEVICE	SUBJECT DEVICE	PRIMARY PREDICATE	REFERENCE PREDICATE	REFERENCE PREDICATE
Device	LONGY Implant	LONGY-N Implant	GM Helix LG (K190958)	Tuff (K140440)	Zygoma GM (K190718)
	Noris Medical Ltd.	Noris Medical Ltd.	Neodent Implant System	Noris Medical Ltd.	Neodent Implant System
Implant Diameter [mm]	Ø 3.75Ø 4.0	Ø 3.75Ø 4.0	Ø 3.75Ø 4.0	Ø 3.3Ø 3.75Ø 4.2Ø 5Ø 6	Ø 4.0
Length [mm]	18, 20, 22, 25	18, 20, 22, 25	20, 22.5, 25	8, 10, 11.5, 13, 16	30, 35, 37.5, 40, 42.5, 47.5, 50,52.5, 55
Material	Titanium alloy Grade 23Ti-6Al-4V ELI	Titanium alloy Grade 23Ti-6Al-4V ELI	Commercially Pure Titanium (ASTM F67)	Titanium alloy Grade 23Ti-6Al-4V ELI	Commercially Pure Titanium(ASTM F67) Grade 4
Surface Treatment	RBM (Resorbable Blasting Media)	RBM (Resorbable Blasting Media)	Sand blasted, acid etched NeoPorossurface.	RBM (Resorbable Blasting Media)	Sand blasted, acid etchedNeoPoros surface.
Sterilization	Gamma Irradiation Sterilization	Gamma Irradiation Sterilization	Gamma Irradiation Sterilization	Gamma Irradiation Sterilization	Gamma Irradiation Sterilization
Single Use	Yes	Yes	Yes	Yes	Yes

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Image /page/7/Picture/0 description: The image contains the logo for Noris Medical. The logo consists of a red abstract shape on the left and the text "NORIS Medical" in gray on the right. Below the company name, the text "Dental Implant Solutions" is written in a smaller, lighter gray font.

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Image /page/8/Picture/0 description: The image shows the logo for Noris Medical. The logo consists of a red abstract shape resembling the letter 'N' on the left, followed by the text "NORIS Medical" in gray. Below the company name, the text "Dental Implant Solutions" is written in a smaller, lighter gray font.

VII. SUBSTANTIAL EQUIVALENCE DISCUSSION

The subject devices and the primary predicate device have equivalent intended use and Indications for Use statements. Both indicated for splinted restorations utilizing a minimum of two implants to support fixed or removable prosthetic in the maxilla and may be loaded immediately when good primary stability is achieved.

The subject devices and the primary predicate devices present similar designs and have the same range of diameters and lengths. The subject devices have additional shorter nonworst-case devices. The subject device LONGY-N have a design modification identical to reference device K151909.

The subject devices and the primary predicate devices also share the same Gamma Irradiation sterilization method.

The subject devices and the primary predicate device have shown equivalent performance strength.

The subject devices and the reference device K140440 share the same material and surface treatment.

The subject devices have the same implant-to-abutment interface design as the reference device K140440.

VIII. PERFORMANCE DATA

Fatigue tests per ISO 14801 were performed to determine the fatigue strength for LONGY Implant and LONGY-N implants, according to FDA Guidance.

The LONGY and LONGY-N implants underwent comprehensive non-clinical testing to demonstrate substantial equivalence to the predicate devices in terms of safety and effectiveness. These evaluations included biocompatibility assessments, sterilization validation, shelf-life testing, mechanical testing, and additional process verifications as detailed below.

Non-clinical worst-case biocompatibility testing for the subject implants was leveraged based on the identical material, manufacturing processes, and surface treatments used in previously cleared devices under K151909. The tests included cytotoxicity (ISO 10993-5), sensitization and irritation (ISO 10993-10), and systemic and subchronic toxicity (ISO 10993-11), which confirmed the biocompatibility of the materials for their intended use.

Non-clinical worst-case MRI review was performed to evaluate the metallic devices in the MRI environment using scientific rationale and published literature (i.e., Woods, Terry O., Jana G. Delfino, and Sunder Rajan. "Assessment of Magnetically Induced Displacement Force and Torque on Metal Alloys Used in Medical Devices." Journal of Testing and Evaluation 49.2 (2019): 783-795), based on the entire system to include all variations (all compatible implant bodies, dental abutments, and fixation screws) and material compositions. The rationale addressed parameters per the FDA Guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment", including magnetically induced displacement force and torque.

Similarly, the RBM (Resorbable Blasting Media) surface treatment process for the subject implants was leveraged, as it is identical to the surface treatment validated for Noris Medical implants cleared under K153043. This ensures consistent adherence to specifications and supports the reliability of the implants' surface properties.

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Image /page/9/Picture/0 description: The image shows the logo for Noris Medical. The logo consists of a red abstract shape on the left and the words "NORIS Medical" in gray on the right. Below the words "NORIS Medical" are the words "Dental Implant Solutions" in a smaller, lighter gray font.

Furthermore, the sterilization process for the subject implants was leveraged, as it employs the same gamma irradiation method validated in accordance with ISO 11137-1 and ISO 11137-2, achieving a Sterility Assurance Level (SAL) of 10^-6. This method has been successfully validated for previously cleared devices under K140440, demonstrating compliance with sterilization requirements.

Based on the equivalence of material, design, and manufacturing processes with previously cleared devices, ensure that the subject implants meet all relevant safety and performance standards. The results of all tests confirmed that the LONGY and LONGY-N implants meet performance and safety requirements for their intended use and demonstrate substantial equivalence to the predicate devices.

l. CONCLUSION

Noris Medical's comparative analysis clearly demonstrates that any differences between our subject devices and predicate devices do not compromise safety or effectiveness. Modifications or improvements made to the design aim to enhance performance and patient outcomes without deviating from the fundamental characteristics of predicate devices.

Regulation Number and Section

§ 872.3640 Endosseous dental implant.

(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.