(264 days)
No
The 510(k) summary describes a dental implant system made of titanium alloy. The description focuses on the material, dimensions, intended use, and mechanical testing. There is no mention of AI, ML, image processing, or any software-driven features that would suggest the incorporation of AI/ML technology.
Yes.
The device is an implantable dental device designed to support prosthetic devices to restore function to partially or fully edentulous jaws, which aligns with the definition of a therapeutic device.
No
The device description clearly states "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." This describes a restorative implant, not a device used to diagnose a condition.
No
The device description clearly states the device is a physical dental implant made of Titanium alloy, which is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use describes a surgical implant for supporting dental prosthetics in the maxilla. This is a device used in vivo (within the body) for structural support.
- Device Description: The description details a physical implant made of titanium alloy, designed for surgical placement.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is clearly designed for surgical implantation in vivo.
N/A
Intended Use / Indications for Use
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.
Product codes
DZE
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 degrees (≤30).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
maxilla, upper jaws
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K140440, K190718, K151909, K153043
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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.
1
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.
2
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
3
Indications for Use
510(k) Number (if known) K241462
Device Name LONGY Implant and LONGY-N Implant
Indications for Use (Describe)
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.
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
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).
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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 be | ||||
| used with matching abutments. | Threaded root-form implant with 2 | ||||
| flat surfaces to be used with | |||||
| matching abutments. | Threaded root-form implant with internal | ||||
| GM Morse taper connection with internal | |||||
| hex. | Threaded root-form implant to be | ||||
| used with matching abutments. | Threaded root-form implant to be | ||||
| used with matching abutments, | |||||
| made of Titanium grade 4. | |||||
| With 2 flat surfaces. | |||||
| Indication for Use | 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. | 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 or two-stage surgical | |||||
| operation. | The Neodent Implant System is intended | ||||
| to be surgically placed in the bone of the | |||||
| upper or lower jaw to provide support for | |||||
| prosthetic devices, such as artificial teeth, | |||||
| to restore chewing function. It may be | |||||
| used with single- stage or two-stage | |||||
| procedures, for single or multiple unit | |||||
| restorations, and may be loaded | |||||
| immediately when good primary stability is | |||||
| achieved and with appropriate occlusal | |||||
| loading. The Neodent GM Helix LG | |||||
| implants can be placed bicortically in | |||||
| cases of reduced bone density. The | |||||
| Neodent GM Helix LG implants are only | |||||
| indicated for multiple unit restorations in | |||||
| splinted applications that utilize at least | |||||
| two implants. | Noris Medical Ltd Dental Implants | ||||
| System is intended to replace | |||||
| missing tooth/teeth in either jaw for | |||||
| supporting prosthetic devices that | |||||
| may aid in restoring the patient's | |||||
| chewing function. The procedure | |||||
| can be accomplished in a one- | |||||
| stage or two-stage surgical | |||||
| operation. All implants are | |||||
| appropriate for immediate loading | |||||
| when good primary stability is | |||||
| achieved and with appropriate | |||||
| occlusal loading. | Zygomatic Implants are indicated | ||||
| for surgical installation in the | |||||
| zygoma region, in cases of severe | |||||
| jaw resorption, in order to restore | |||||
| patient esthetics and chewing | |||||
| function. Zygomatic Implants are | |||||
| recommended for the posterior | |||||
| (pre-molar/molar) region, one | |||||
| implant on each side, with at least | |||||
| two standard dental implants in the | |||||
| anterior region to support a fixed | |||||
| restoration. Zygomatic Implants | |||||
| may be loaded immediately when | |||||
| good primary stability is achieved | |||||
| and with appropriate occlusal | |||||
| loading | |||||
| 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 3.75 | ||||
| Ø 4.0 | Ø 3.75 | ||||
| Ø 4.0 | Ø 3.75 | ||||
| Ø 4.0 | Ø 3.3 | ||||
| Ø 3.75 | |||||
| Ø 4.2 | |||||
| Ø 5 | |||||
| Ø 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 23 | ||||
| Ti-6Al-4V ELI | Titanium alloy Grade 23 | ||||
| Ti-6Al-4V ELI | Commercially Pure Titanium (ASTM F67) | Titanium alloy Grade 23 | |||
| Ti-6Al-4V ELI | Commercially Pure Titanium | ||||
| (ASTM F67) Grade 4 | |||||
| Surface Treatment | RBM (Resorbable Blasting Media) | RBM (Resorbable Blasting Media) | Sand blasted, acid etched NeoPoros | ||
| surface. | RBM (Resorbable Blasting Media) | Sand blasted, acid etched | |||
| NeoPoros 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.