(301 days)
Not Found
No
The 510(k) summary describes a system of dental implants and associated components made of titanium alloy. The description focuses on the materials, surface treatment, and mechanical testing. There is no mention of software, algorithms, image processing, or any terms related to AI or ML. The performance studies are non-clinical and focus on material properties and sterilization.
No.
The device is a dental implant system intended to replace missing teeth and aid in restoring chewing function, which is a structural and functional restoration, not a therapeutic treatment for disease or illness.
No
The device is a dental implant system intended to replace missing teeth and support prosthetic devices. Its function is restorative, not diagnostic.
No
The device description explicitly states it consists of physical components made of titanium alloy, such as implants, abutments, and superstructures. It also describes manufacturing processes and physical testing, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to replace missing teeth and support prosthetic devices to restore chewing function. This is a surgical and prosthetic procedure performed directly on the patient's body.
- Device Description: The device consists of dental implants, abutments, and superstructures, which are physical components implanted into the jawbone.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not interact with or analyze such specimens.
- Performance Studies: The performance studies described focus on the physical properties of the implants (surface analysis, sterilization, aging, fatigue testing), not on the analysis of biological samples.
Therefore, the Noris Medical Ltd Dental Implants System is a medical device used for surgical and prosthetic purposes, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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 surgical operation. All implants are appropriate for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
Mono implants are specifically indicated for replacing maxillary lateral incisors and mandibular central and lateral incisors. They are used for immediate, non-occlusal provisionalization in single-tooth restorations. Multiple-unit restorations should be splinted together and may be used immediately when clinically appropriate.
Product codes (comma separated list FDA assigned to the subject device)
DZE, NHA
Device Description
The Noris Medical Dental Implants System consists of one or two stage endosseous form dental implants, internal hexagonal and one piece implants system. Abutments and Superstructures are used in conjunction with an endosseous dental implant fixture to aid in prosthetic rehabilitation. The implantation procedure can be accomplished in a one-stage or two-stage surgical operation for all implants type beside the Mono which is for one stage only.
The Noris Medical Dental Implants System includes prosthetics components that consist of healing caps, Cemented restorations: straight and angular abutments (narrow/narrow top/wide/shoulder/anatomic/esthetic abutment); Screw retained restorations: Multi unit, Esthetic screw abutments; Removable restorations : Vari connect abutments, Ball attachments, Flat attachments. Accessories: Cover screw, Angular Adaptor, Locator, transfer, Analog and others.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Maxillary lateral incisors and mandibular central and lateral incisors (specifically for Mono implants). Generally, "missing tooth/teeth in either jaw".
Indicated Patient Age Range
Edentulous or partially edentulous individuals.
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)
Non-clinical tests were performed.
SEM and Surface analysis (EDS) after SLA process demonstrated the morphology and cleanliness of the final product.
Sterilization validation tests were conducted in compliance with ANSI/AAMI/ISO 11137-1:06 and EN ISO 11137-2:12 in order to ensure safety and effectiveness related to Noris Medical Dental Implants System. Test results have demonstrated that the SAL of 10th was achieved and all testing requirements were met.
Accelerated aging per ASTM-F-1980:07 have been applied on the final packaging followed by validating durability to peel, dye and burst tests conditions in order to substantiate 5 years shelf life.
Static and dynamic compression performance test was conducted per ISO 14801: 07-Dentistry-Implants-Dynamic fatigue test for Endosseous Dental implants. The worst case scenario was chosen based on the FDA guideline "Class II Special Controls Guidance Document: Root form for Endosseous dental implants and Endosseous dental Implant Abutments".
The results of the testing indicate that the Noris Medical Dental Implants System is substantial equivalent to the predicate devices sighted in this submission.
No clinical studies were performed.
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.
K040807-MIS, K080162-MIS, K112440-A.B. dental, K132125-A.B.dental, K061477 Nobel Biocare
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.
Not Found
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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized image of a human figure in profile, with three overlapping faces. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the figure. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 19,2014
Noris Medical, Ltd. Dr. Raanan Aloni OA/RA Director 8 Hataasia Street Nesher 3688808 ISRAEL
Re: K140440
Trade/Device Name: Noris Medical Dental Implants System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous dental implant Regulatory Class: II Product Code: DZE, NHA Dated: November 19, 2014 Received: November 21, 2014
Dear Dr. Aloni:
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 (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. 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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Page 2 - Dr. Aloni
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
of Surveillance and Biometrics/Division of Postmarket Surveillance.
Sincerely yours,
Susan Runno, DDS, MA
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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Image /page/2/Picture/0 description: The image shows the logo for Noris Medical. The logo consists of a red abstract shape on the left, followed by the text "NORIS Medical" in a combination of red and gray. Below the text, there is a smaller line of text that reads "ENGINEERED FOR HEALTH" in gray.
Indications for Use
510(k) Number: K140440
Device Name: Noris Medical Dental Implants System
Indications for Use:
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 surgical operation. All implants are appropriate for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
Mono implants are specifically indicated for replacing maxillary lateral incisors and mandibular central and lateral incisors. They are used for immediate, non-occlusal provisionalization in single-tooth restorations. Multiple-unit restorations should be splinted together and may be used immediately when clinically appropriate.
Prescription Use Yes Over-The-Counter Use No AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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Image /page/3/Picture/0 description: The image shows the logo for Noris Medical. The logo consists of a red abstract shape on the left, followed by the text "NORIS Medical" in a light gray sans-serif font. Below the text "NORIS Medical" is the text "ENGINEERED FOR HEALTH" in a smaller, darker gray sans-serif font.
510(k) Summary
In accordance with 21 CFR 807.92 of the Federal Code of Regulations the following 510(k) summary is submitted for the Noris Medical Dental Implants System
1. GENERAL INFORMATION
| Date Prepared: | 11th December 2014 |
|---|---|
| Noris Medical Dental Implants System | |
| Common Name: | Endosseous Dental Implant |
| Classification Name: | Implant, Endosseous, Root-Form |
| Class: | II |
| Product Code: | DZE/NHA |
| CFR section: | 21 CFR§872.3640 |
| Device panel: | Dental |
| Legally Marketed | |
| Predicate Device: | K040807-MIS, K080162-MIS, K112440-A.B. dental, K132125- |
| A.B.dental, K061477 Nobel Biocare | |
| Submitter: | Noris Medical Ltd. 8 Hataasia street, Nesher 3688808, Israel |
| Contact: | Dr. Raanan Aloni, QA/RA Director |
| E-mail: aloni@norismedical.com | |
| and Simha Sibony- Regulatory Affairs specialist | |
| E-mail: simha.qualitech@gmail.com | |
| Tel: +972-73-796-4477 | |
| Fax: +972-4-695-0991 |
2. DEVICE DESCRIPTION
The Noris Medical Dental Implants System consists of one or two stage endosseous form dental implants, internal hexagonal and one piece implants system
Abutments and Superstructures are used in conjunction with an endosseous dental implant fixture to aid in prosthetic rehabilitation.
The implantation procedure can be accomplished in a one-stage or two-stage surgical operation for all implants type beside the Mono which is for one stage only.
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Image /page/4/Picture/0 description: The image shows the logo for Noris Medical. The logo consists of a red abstract shape on the left, followed by the text "NORIS Medical" in a combination of red and gray. Below the text, there is a smaller line of text that reads "ENGINEERED FOR HEALTH" in gray.
2.A Implants sizes and dimensions:
Tuff Implants
With their three thread zones, Tuff implants have been uniquely designed according to the anatomy of the bone structure. The lower V-shape thread zone enables self-tapping. The middle zone square type thread is used for compressing cancellous bone. Micro threads are
on the upper zone.
Diameter 3.3, 3.75, 4.2, 5mm Length 8, 10, 11.5,13,16 mm Diameter 6 mm Length 8, 10, 11.5.13 Made of titanium alloy Ti 6Al 4V ELI
Tuff TT Implants
Tuff TT Implants share the same three-thread zone concept as Tuff implants. The taper top converging coronal shape allows platform switch technology .
Diameter 4.2, 5 mm ; Length 8, 10, 11.5,13,16 mm Diameter 6 mm Length 8, 10, 11.5.13 Made of titanium alloy Ti 6Al 4V ELI
Onyx Implants
Onyx implants are specially designed for treatments involving placement in type I and type II bone.
Diameter 3.3, 3.75, 4.2, 5, mm Length 8, 10, 11.5,13, 16 mm Diameter 6 mm Length 8, 10, 11.5,13 Made of titanium alloy Ti 6Al 4V ELI
Mono Implants
Mono implants are specifically indicated for replacing maxillary lateral incisors and mandibular central and lateral incisors. The implants are cleared for immediate, nonocclusal provisionalization in single-tooth restorations. Multiple-unit restorations should be splinted together. In appropriate clinical conditions Mono Implants may be loaded immediately.
Diameter 3.0, 3.3, 3.75, 4.2 ; Length 10, 11.5, 13,16 mm Diameter 5 mm Length 10, 11.5, 13 mm Made of titanium alloy Ti 6Al 4V ELI
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Image /page/5/Picture/0 description: The image contains the logo for Noris Medical. The logo consists of a red abstract shape on the left, followed by the text "NORIS Medical" in a combination of red and gray. Below "NORIS Medical" is the text "ENGINEERED FOR HEALTH" in gray. The logo appears to be for a medical or healthcare-related company.
The Noris Medical Dental Implants System includes prosthetics components that consist of healing caps, Cemented restorations: straight and angular abutments (narrow/narrow top/wide/shoulder/anatomic/esthetic abutment); Screw retained restorations: Multi unit, Esthetic screw abutments; Removable restorations : Vari connect abutments, Ball attachments, Flat attachments. Accessories: Cover screw, Angular Adaptor, Locator, transfer, Analog and others.
2.B Prosthetics size and dimensions
Healing Caps
Healing caps prepare the site for the superstructure insertion and "shapes" the soft tissue surrounding the implant.
Diameter 3.8, 4.6, 5.5, 6.3 mm; Length 2, 3, 4, 5, 6, 7 mm Made of titanium alloy Ti 6Al 4V ELI
Straight Abutments- cemented retained reconstruction
A wide variety of titanium straight abutments are available for use in different situations.
- Narrow abutments ●
- Wide abutments
- Anatomic abutments
- Narrow shoulder abutments
Diameter 5.2 mm; Length 9, 10, 11, 12 mm; shoulder 1, 2, 3, 4 mm Diameter 4.5 mm; Length 8.5, 9.5, 10.5, 11.5 mm; shoulder 1, 2, 3, 4 mm Diameter 4.5 mm: Length 8.5. 9.5. 10.5. 11.5. 12.5 mm Diameter 3.75 mm; Length 8.5 mm; shoulder 0.5, 1.5, 2.75 mm Diameter 3.8 mm; Length 6, 8 mm Diameter 5.5 mm; Length 9, 11 mm Made of titanium alloy Ti 6Al 4V ELI
*Implant – abutment connection i same 3.75mm platform for all abutments .
Angular Abutments - cemented retained reconstruction
The abutments are available with angles of 15° and 25° degrees.
- Angular, narrow abutments are used in minimal prosthetic space.
- Angular anatomic abutments have a shape that is contoured to the gingiva. This enables an individualization of the prosthetic unit. Variety of shoulder heights provides solutions for the alignment of the abutment with the soft tissue topography.
- Narrow top angular abutment allows minimal technical preparation. ●
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Anatomic - 15° and 25°:
Diameter 5.4 mm; Length 9.5, 10.5, 11.5, 12.5 mm; shoulder 1, 2, 3, 4
mm
Anatomic - 15°: Diameter 5.4 mm; Length 8.5 mm; shoulder 0.8 mm
Standard - 15° and 25°: Diameter 5.4 mm; Length 9, 11 mm
Narrow - 15°: Diameter 4 mm; Length 9 mm
Narrow Top - 15° and 25°: Length 9 mm
Made of titanium alloy Ti 6A1 4V ELI
Esthetic Abutments
The esthetic abutments are available in different shapes, sizes and angulations.
Straight - Diameter 5.4 mm; Length 8.5, 9.5, 10.5 mm; shoulder 1, 2, 3 mm Angulated - 15° and 25°: Diameter 4.5 mm; Length 9, 11 mm Made of titanium alloy Ti 6Al 4V ELI
Color, using an anodizing technique, for categorical considerations only.
Esthetic Screw Abutments - screw retained restoration
Esthetic Screw Abutment is designed for the screw retained rehabilitation process on single or multiple units.
Base: Length 0.5, 1.5, 2.5 mm Screw: Length 10.5, 11.5, 12.5 mm Made of titanium alloy Ti 6Al 4V ELI
Plastic Castable Abutments on Titanium Bases enable the dental laboratory to cast on an accurate Titanium base. The machined Titanium base provides an accurate fit to the implant.
Hexed: Diameter 4.5 mm; Length 10.5 mm Made of titanium alloy Ti 6A14V ELI + Delrin
No angular correction may be fabricated on Titanium base plastic castable abutments
Multi-Unit - screw retained reconstruction
The Multi-Unit system comprises a full range of sizes for both the upper and lower jaws. Straight, 17°, 30° adaptors, in a variety of heights, connects to a wide range of complementary products.
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Image /page/7/Picture/0 description: The image shows the logo for Noris Medical. The logo consists of a red abstract shape on the left, followed by the words "NORIS Medical" in red and gray. Below the words "NORIS Medical" is the phrase "ENGINEERED FOR HEALTH" in gray.
Straight - Length 1, 2, 3 mm Angulated 17° and 30° - Length 2, 3, 4 mm Made of titanium alloy Ti 6Al 4V ELI
Vari-Connect - screw retained or removable reconstruction
The Vari-Connect system presents a complete solution for removable prostheses on tilted implants. Straight, 17°, 30° adaptors are available. Complementary products are fixed to the adaptors by the adaptor thread.
Angulated 17° and 30° - Length 2, 3, 4 mm Made of titanium alloy Ti 6Al 4V ELI
Ball attachment - removable
The ball attachment superstructure is intended to secure a removable prosthesis.
Length; 0.5, 1, 2, 3, 4, 5, 6 mm Made of titanium alloy Ti 6Al 4V ELI
Flat attachment- removable
The Flat attachment superstructure is intended to secure a removable prosthesis.
Length; 0.5, 1, 2, 3, 4, 5 mm Made of titanium alloy Ti 6Al 4V ELI
Materials and Production:
The implants and prosthetic components are manufactured from Titanium alloy (Ti 6Al 4V ELI) complying with standard ASTM F 136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for surgical implant applications. Noris Medical employs the SLA (Sandblasted, Large grit, Acid etched) surface treatment technology.
The product is packaged using materials known in the industry to be appropriate for medical device packaging and is provided with a minimum sterility assurance level of 10° validated in compliance with ANSI/AAMI/ISO 11137-1 Sterilization of healthcare products --Radiation -- Part 1:Requirements for development, validation and routine control of a sterilization process for medical devices.
3. INTENDED USE
Noris Medical 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
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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 on the left, followed by the text "NORIS Medical" in a combination of red and gray. Below the text, there is a tagline that reads "ENGINEERED FOR HEALTH" in gray.
operation. All implants are appropriate for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
Mono implants are specifically indicated for replacing maxillary lateral incisors and mandibular central and lateral incisors. They are used for immediate, non-occlusal provisionalization in single-tooth restorations. Multiple-unit restorations should be splinted together and may be used immediately when clinically appropriate.
4. SUBSTANTIAL EQUIVALENCE CLAIMED TO PREDICATE DEVICES
Noris Medical Dental Implants System(Noris) is substantially equivalent to M.I.S K040807,and M.I.S. K080162 in terms of intended use, design, materials used, safety and performance testing.
Identification of the Legally Marketed Predicate Devices Used to Claim Substantial Equivalence:
| Device Name | MIS Dental Implant System | Noris Medical Dental Implants System |
|---|---|---|
| 510(k)Number | K040807 | |
| K080162(Uno) | K140440 | |
| Sponsor | M.I.S. | Noris Medical |
| Product Code | DZE/NHA | DZE/NHA |
| Patient Population | Edentulous or partially edentulous individuals | Edentulous or partially edentulous individuals |
| Material | Titanium alloy | Titanium alloy |
| Diameter(mm) | Biocom | |
| 3.3, 3.75, 4.2, 5, 6. | ||
| Seven | ||
| 3.3, 3.75, 4.2, 5,6 | ||
| Uno | ||
| 3.0, 3.5 | Onyx | |
| 3.3, 3.75, 4.2, 5, 6 | ||
| Tuff | ||
| 3.3, 3.75, 4.2, 5, 6 | ||
| Tuff TT | ||
| 4.2, 5, 6 | ||
| Mono | ||
| 3.0, 3.3,3.75,4.2,5 | ||
| Length (mm) | Biocom | |
| 8, 10, 11.5, 13, 16 | ||
| Seven | ||
| 8, 10, 11.5, 13, 16 | ||
| Uno | ||
| 10,11.5, 13, 16 | Onyx | |
| 8,10,11.5,13,16 | ||
| Dia 6 -Length 8,10,11.5,13 | ||
| Tuff, Tuff TT | ||
| 8,10,11.5,13, 16 | ||
| Dia 6 -Length 8,10,11.5,13 |
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Image /page/9/Picture/0 description: The image is a logo for Noris Medical. The logo consists of a red abstract shape on the left, followed by the words "NORIS Medical" in red and gray. Below the words "NORIS Medical" is the phrase "ENGINEERED FOR HEALTH" in gray.
| Mono | ||
|---|---|---|
| 10,11.5,13,16 | ||
| Dia 5 –Length 10,11.5,13 | ||
| Abutments° | 0,15,25 | 0,15,17,25,30 |
| Design | Root Form | Root Form |
| Prosthetic | Internal Hex | Internal Hex |
| Connection | ||
| Sterility | Gamma irradiation | Gamma irradiation |
| Immediate loading or | Immediate loading or | |
| Clinical | for loading after a | for loading after a conventional healing |
| procedure | conventional healing period | period |
The prosthetics components of Noris Medical Dental Implants System are substantially equivalent to K112440-A.B. dental, K132125-A.B.dental, K061477 Nobel Biocare in terms of intended use, design, materials used, safety and performance testing.
Identification of the Legally Marketed Predicate Devices Used to Claim Substantial Equivalence:
| AB Dental | Noris Medical | |
|---|---|---|
| Feature | ||
| K510 | K112440 | Present submission |
| Product Name | P0-Healing Cap | Healing cap |
| Intended use | Used to allow the gingiva to | |
| heal around implants | Used to allow the gingiva to heal around | |
| implants. | ||
| Material | Titanium alloy | Titanium alloy |
| Diameter (mm) | 3.75 | 3.8,4.6,5.5,6.3 |
| Height (mm) | 2,3,4,5,6,7 | 2,3,4,5,6,7 |
| Angle | 0 | 0 |
| Sterility | Non sterile | Non sterile |
Healing cap
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Image /page/10/Picture/0 description: The image contains the logo for Noris Medical. The logo consists of a red abstract shape on the left, followed by the text "NORIS Medical" in red and gray. Below the text, there is a tagline that reads "ENGINEERED FOR HEALTH" in gray.
Straight abutment
| AB Dental | Noris Medical | |
|---|---|---|
| Feature | ||
| Product Name | P3 - abutment anti rotation | Straight abutment |
| K510 | K112440 | K140440 |
| Intended use | The straight abutment is used in | |
| the fabrication of cement- | ||
| retained restorations, single | ||
| crowns or bridges. | The straight abutment is used in the | |
| fabrication of cement-retained | ||
| restorations, single crowns or bridges. | ||
| Material | Titanium alloy | Titanium alloy |
| Diameter (mm) | 3,3.75,5 | 3.75,3.8,4.5,5.2,5.5,9 |
| Height (mm) | 5,7,9,12,15 | 6,8,8.5,9,9.5,10,10.5,11,11.5,12,12.5,15 |
| Angle | 0 | 0 |
| Sterility | Non sterile | Non sterile |
Vari-connect
| Feature | AB Dental | Noris Medical |
|---|---|---|
| K510 | K132125 | K140440 |
| Product Name | P5-P14 Ball for Angular Adaptor | Vari-connect |
| Intended use | To connect a removable denture to an | |
| implant. | The Vari-Connect system is intended to | |
| connect a removable denture to an implant | ||
| Material | Titanium alloy | Titanium alloy |
| Diameter (mm) | 3.5,3.9 | 4.8 |
| Height (mm) | 1,3 | 2,3,4 |
| Angle (º) | 17,30 | 0, 17, 30 |
| Sterility | Non sterile | Non sterile |
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Image /page/11/Picture/0 description: The image shows the logo for Noris Medical. The logo consists of a red abstract shape on the left, followed by the text "NORIS Medical" in a red sans-serif font. Below the text is the tagline "ENGINEERED FOR HEALTH" in a smaller, gray sans-serif font.
Esthetic Screw Abutments
| Feature | AB Dental | Noris Medical |
|---|---|---|
| K210 | K132125 | K140440 |
| Product Name | P7 Anti-rotation Aesthetic | |
| Abutment, | Esthetic Screw Abutments | |
| Intended use | Suitable for restorations of a | |
| single implant or screwed | ||
| bridge on non-parallel implants | Esthetic Screw Abutment is intended for the | |
| screw retained rehabilitation process on | ||
| single or multiple units. | ||
| Material | Titanium alloy | Titanium alloy |
| Diameter (mm) | 3.75 | 4.7 |
| Height (mm) | 1,2,3 | 0.5,1.5,2.5 |
| Angle (의) | 0 | 0 |
| Sterility | Non sterile | Non sterile |
Ball attachment
| Feature | AB Dental | Noris Medical |
|---|---|---|
| K510 | K132125 | K140440 |
| Product Name | P5- Ball attachment | |
| abutment | Ball attachment | |
| Intended use | To connect a removable | |
| denture to an implant | The ball attachment superstructure is | |
| intended to secure a removable prosthesis. | ||
| Material | Titanium alloy | Titanium alloy |
| Height (mm) | 1,2,3,4,5,6 | 0.5,1,2,3,4,5,6,7 |
| Angle (º) | 0 | 0 |
| Sterility | Non sterile | Non sterile |
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Image /page/12/Picture/0 description: The image contains the logo for Noris Medical. The logo consists of a red abstract shape on the left, followed by the text "NORIS Medical" in a sans-serif font. Below the text, there is a tagline that reads "ENGINEERED FOR HEALTH" in a smaller, lighter font.
Flat attachment
| Feature | AB Dental | Noris Medical |
|---|---|---|
| Product Name | P55 low connector | Flat attachment |
| K510 | K132125 | K140440 |
| Intended use | Over denture attachment system | |
| for easy connection between the | ||
| denture and the implant | The Flat attachment superstructure is intended | |
| to secure an overdenture | ||
| Material | Titanium alloy | Titanium alloy |
| Diameter (mm) | 3.75 | 3.75 |
| Height (mm) | 1,2,3,4,5,6,7,8 | 0.5,1,2,3,4,5 |
| Angle (º) | 0 | 0 |
| Sterility | Non sterile | Non sterile |
Multi-Unit
| Feature | Nobel biocare | Noris Medical |
|---|---|---|
| K510 | K061477 | K140440 |
| Product Name | Multi-unit | Multi-Unit |
| Intended use | Nobel Biocare's Multi-Unit Abutment | |
| is a premanufactured prosthetic | ||
| component intended for use as an aid | ||
| in prosthetic rehabilitation. | The Multi-Unit Abutment is a prosthetic | |
| device that fits only the 2.42 mm internal | ||
| Hex implants. The device has been | ||
| developed for long-term, permanent use. | ||
| The Multi-Unit system provides a solution | ||
| for screw-retained prosthetic rehabilitation | ||
| Material | Titanium alloy | Titanium alloy |
| Diameter (mm) | 3.5,3.9 | 4.8 |
| Height (mm) | 2,2.5,3,3.5,4,4.5,5 | 1,2,3,4 |
| Angle (º) | Up to 30 | 0, 17, 30 |
| Sterility | Non sterile | Non sterile |
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Image /page/13/Picture/0 description: The image contains the logo for Noris Medical. The logo consists of a red abstract shape on the left, followed by the text "NORIS Medical" in a larger, bolder font. Below the text, there is a smaller line that reads "ENGINEERED FOR HEALTH".
Evidence of equivalence has been demonstrated through:
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- The Noris Medical Dental Implants System intended use and indications for use were previously cleared by FDA for the predicate devices.
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- The technical characteristics of the Noris Medical Dental implants System are similar to those of the predicate devices.
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- Safety and performance testing of the Noris Medical Dental implants System are similar to those of the predicate devices.
Therefore, the Noris Medical Dental Implants System is substantially equivalent to the predicate devices in terms of intended use, materials used, and technological characteristics
4. NON-CLINICAL TEST
The components are manufactured from medical grade Titanium alloy (Ti 6Al 4V ELI) per ASTM F136.
SEM and Surface analysis (EDS) after SLA process demonstrated the morphology and cleanliness of the final product.
Sterilization validation tests were conducted in compliance with ANSI/AAMI/ISO 11137-1:06 and EN ISO 11137-2:12 in order to ensure safety and effectiveness related to Noris Medical Dental Implants System.
Test results have demonstrated that the SAL of 10th was achieved and all testing requirements were met.
Accelerated aging per ASTM-F-1980:07 have been applied on the final packaging followed by validating durability to peel, dye and burst tests conditions in order to substantiate 5 years shelf life.
Static and dynamic compression performance test was conducted per ISO 14801: 07-Dentistry-Implants-Dynamic fatigue test for Endosseous Dental implants. The worst case scenario was chosen based on the FDA guideline "Class II Special Controls Guidance Document: Root form for Endosseous dental implants and Endosseous dental Implant Abutments".
The results of the testing indicate that the Noris Medical Dental Implants System is substantial equivalent to the predicate devices sighted in this submission.
5. CLINICAL TEST
No clinical studies were performed.
6. CONCLUSION
The results of the testing conducted on the Noris Medical Dental Implants System demonstrated that the system is substantially equivalent to the named predicated devices in terms of functional, mechanical properties, indications for use and material.