(270 days)
Not Found
No
The summary describes a physical dental implant system and its materials, design, and clinical testing. There is no mention of software, algorithms, or any technology that would typically incorporate AI or ML.
Yes
The device is intended to replace missing teeth, restore chewing function, and support prosthetic devices, which are all therapeutic benefits for the patient.
No
The device is a dental implant system used to replace missing teeth and support prosthetic devices, not to diagnose medical conditions.
No
The device description clearly details physical implants and prosthetic components made of titanium alloy, indicating it is a hardware medical 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 function, not a diagnostic one performed on in vitro samples.
- Device Description: The device is a dental implant system made of titanium alloy, designed for surgical implantation into bone. This is a physical implant, not a reagent, instrument, or system intended for use in the examination of specimens derived from the human body.
- Performance Studies: The performance studies focus on the success rate of the implant in patients, which is a measure of surgical and prosthetic outcome, not diagnostic accuracy.
IVD devices are used to perform tests on samples like blood, urine, or tissue to diagnose diseases or conditions. This device is a medical implant used in a surgical procedure.
N/A
Intended Use / Indications for 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 operation. All implants are appropriate for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
Noris Medical Zygomatic Dental Implant System is intended to be implanted in the upper jaw arch to provide support for fixed or removable prosthetic devices in patients with partially or fully edentulous maxillae.
Product codes (comma separated list FDA assigned to the subject device)
DZE, NHA
Device Description
Noris Medical Dental Implants are tapered internal hex implants, designed to enable easy insertion while supporting excellent initial stability. The variable thread design enables self-tapping, thus providing solutions for a variety of bone conditions. Noris Medical multi-design features offer a solution for immediate placement and immediate loading. The implantation procedure can be accomplished in a one-stage or two-stage surgical operation for all implants type beside the Mono (Noris Medical cleared K140440) which is for one stage only. Packaging has been designed for quick identification and easy opening.
The Noris Medical Zygomatic Dental Implant is designed to provide a solution for cases of atrophic maxilla. The shape of the Noris Medical Zygomatic Dental Implant consists of sharp threads at the apical part. The platform of the Noris Medical Zygomatic Dental Implant is 3.75mm platform, with internal Hex connection. The Noris Medical Zygomatic Dental Implant is available in a large variety of lengths, from 30 mm to 57.5 mm.
Prosthetic Components: Straight, 17°, 30° Multi unit and Vari connect prosthetic system are already cleared under previous Noris Medical 510k submission -K140440. Multi unit and Vari connect 45° prosthetic system are subject of this current submission as a part of the Zyqomatic Dental Implant System.
The Multi-Unit system provides a solution for screw-retained prostheses even on complicated-to-restore implants (for example, multiple tilted implants). The Multi-Unit system comprises a full range of sizes for both the upper and lower jaws. Straight, 17°, 30°, 45° components, in a variety of heights, connects to a wide range of complementary products.
The Vari-Connect system presents a complete solution for removable prostheses on tilted implants. It provides all the required equipment for removable prostheses, both on ball attachments and flat attachments, covering a wide range of possible situations. Straight, 17°, 30°, 45° components are available. Complementary products are fixed to the adaptors by the adaptor thread.
Materials and Production: The implants and prosthetic components are manufactured from Titanium alloy 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 RBM (Resorbable Blast Media) surface treatment technology. The product is packed 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Computed Tomography (CT), Panoramic radiographs
Anatomical Site
Upper jaw arch, maxillae, either jaw
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)
Non-clinical testing included SEM and Surface analysis (EDS) after RBM process, sterilization validation tests (ANSI/AAMI/ISO 11137-1:06 and EN ISO 11137-2:12 and ANSI/AAMI ST79:2010 & A1:2010), biocompatibility tests (AAMI ANSI ISO 10993-5: 2009 (R)2014 and AAMI ANSI ISO 10993-11: 2006 (R)2010), accelerated aging per ASTM-F-1980:07, and static and dynamic compression performance testing per ISO 14801: 07. Comparative testing was conducted according to a modified ISO 14801 set-up. The results of the testing indicate that the Noris Medical Zygomatic Dental Implant is substantially equivalent to the predicate devices.
Clinical evaluation: A series of retrospective, randomized clinical case studies.
Sample Size: 18 patients (a total of 29 Zygomatic implants).
Data Source: Implanted during the years 2013 to 2014 in one clinical site in Israel.
Key Results: Immediate occlusal loading was employed in all 29 cases. Patients were evaluated at a minimum of 6 months post-surgery. The success endpoint was identified as osseointegration following implant placement. A success rate of 96% was obtained after at least 6 months follow up. Those results correspond to the CSR (Cumulative Success Rate) reported worldwide by the sponsor for Zygomatic dental implants.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
96% success rate (osseointegration following implant placement)
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.
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 features a stylized caduceus symbol, which is often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 8, 2016
Noris Medical Ltd. Ms. Simha Sibony VP Regulatory Science 8 Hataasia St. Nesher, 3688808 ISRAEL
Re: K151909
Trade/Device Name: Noris Medical Zygomatic Dental Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE, NHA Dated: March 1, 2016 Received: March 9, 2016
Dear Ms. Sibony:
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.
1
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 devicerelated 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 Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education 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.
Sincerely yours,
Tina Kiang -S
for 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
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
Noris Medical Zygomatic Dental Implant System
Indications for Use (Describe)
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 operation. All implants are appropriate for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
Noris Medical Zygomatic Dental Implant System is intended to be implanted in the upper jaw arch to provide support for fixed or removable prosthetic devices in patients with partially or fully edentulous maxillae.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017 See PRA Statement below.
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Druq Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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K151909 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 Zygomatic Dental Implant System
1. GENERAL INFORMATION
| Date Prepared: | April 7, 2016 |
|---|---|
| Common Name: | Noris Medical Zygomatic Dental Implant System |
| 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: | Primary Predicate: K093562-SOUTHERN IMPLANTS Inc. |
| K140440-Noris Medical Ltd. | |
| Submitter: | Noris Medical Ltd. 8 Hataasia street, Nesher 3688808, |
| Israel | |
| Contact 1: | Ms. Simha Sibony- VP Regulatory Science |
| Noris Medical Ltd | |
| 8 Hataasia St., Nesher 3688808 ISRAEL | |
| M:+972 52-654-6625 | |
| T: +972 (73) 796-4477 | |
| F: +972 (4) 695-0991 | |
| E:simhas@norismedical.com | |
| Contact 2: | Mr. Aharon Siev, President |
| Noris Medical Ltd | |
| 8 Hataasia St. Nesher 3688808 | |
| ISRAEL | |
| T: +972(73)796-4477 | |
| F: +972(4)695-0991 | |
| E: asiev@norismedical.com |
2. DEVICE DESCRIPTION
- 2.1. BACKGROUND Noris Medical Dental Implants are tapered internal hex implants, designed to enable easy insertion while supporting excellent initial stability. The variable thread design enables self-tapping, thus providing
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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 bold, sans-serif font. Below the text "NORIS Medical" is the text "ENGINEERED FOR HEALTH" in a smaller, lighter font. The logo is clean and modern, and the use of red and gray gives it a professional look.
solutions for a variety of bone conditions. Noris Medical multi-design features offer a solution for immediate placement and immediate loading. The implantation procedure can be accomplished in a one-stage or twostage surgical operation for all implants type beside the Mono(Noris Medical cleared K140440) which is for one stage only. Packaging has been designed for quick identification and easy opening.
The scope of this submission is the following items:
2.2 NORIS MEDICAL ZYGOMATIC DENTAL IMPLANT
The Noris Medical Zygomatic Dental Implant is designed to provide a solution for cases of atrophic maxilla. The shape of the Noris Medical Zygomatic Dental Implant consists of sharp threads at the apical part. The platform of the Noris Medical Zygomatic Dental Implant is 3.75mm platform, with internal Hex connection. The Noris Medical Zygomatic Dental Implant is available in a large variety of lengths, from 30 mm to 57.5 mm.
Zygomatic Implant sizes and dimensions:
Image /page/4/Picture/6 description: The image shows a dental implant. The implant has a diameter of 4.2 mm and lengths of 30, 35, 37.5, 40, 42.5, 45, 47.5, 50, 52.5, 55, and 57.5 mm. The implant is made of titanium alloy Ti 6Al 4V ELI.
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Image /page/5/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 gray sans-serif font. Below the text is the tagline "ENGINEERED FOR HEALTH" in a smaller, lighter gray font.
2.3 PROSTHETIC COMPONENTS FOR NORIS MEDICAL ZYGOMATIC IMPLANT
Background: Straight, 17°, 30° Multi unit and Vari connect prosthetic system are already cleared under previous Noris Medical 510k submission -K140440
Multi unit and Vari connect 45° prosthetic system are subject of this current submission as a part of the Zyqomatic Dental Implant System.
Multi-Unit - screw retained reconstruction
The Multi-Unit system provides a solution for screw-retained prostheses even on complicated-to-restore implants (for example, multiple tilted implants). The Multi-Unit system comprises a full range of sizes for both the upper and lower jaws. Straight, 17°, 30°, 45° components, in a variety of heights, connects to a wide range of complementary products.
Image /page/5/Picture/6 description: The image shows a close-up of a brass-colored plumbing fitting. The fitting has a hexagonal base and a cylindrical top, with a joint in between that allows for angular adjustment. The fitting appears to be new and unused, with a clean and shiny surface.
Angulated 45° - Length 4 mm Made of titanium alloy Ti 6AI 4V ELI
Vari-Connect - screw retained or removable reconstruction
The Vari-Connect system presents a complete solution for removable prostheses on tilted implants. It provides all the required equipment for removable prostheses, both on ball attachments and flat attachments, covering a wide range of possible situations. Straight, 17°, 30°, 45° components are available. Complementary products are fixed to the adaptors by the adaptor thread.
Image /page/5/Picture/10 description: The image shows a close-up of a brass-colored fitting. The fitting has a 90-degree angle and appears to be made of metal. The top part of the fitting has a threaded section, while the bottom part has a hexagonal shape. The fitting is likely used for connecting pipes or hoses in plumbing or other fluid transfer systems.
Angulated 45° - Length 4 mm Made of titanium alloy Ti 6AI 4V ELI
Materials and Production:
The implants and prosthetic components are manufactured from Titanium alloy complying with standard ASTM F 136 Standard Specification for
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Image /page/6/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.
Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for surgical implant applications.
Noris Medical employs the RBM (Resorbable Blast Media) surface treatment technology.
The product is packed 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 onestage or two-stage surgical operation. All implants are appropriate for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
Noris Medical Zygomatic Dental Implant System is intended to be implanted in the upper jaw arch to provide support for fixed or removable prosthetic devices in patients with partially or fully edentulous maxillae.
4. SUBSTANTIAL EQUIVALENCE CLAIMED TO PREDICATE DEVICES
Identification of the Legally Marketed Predicate Devices Used to Claim Substantial Equivalence:
Noris Medical Zygomatic Dental Implant System is substantially equivalent to Primary predicate -Southern Implants Zygomatic Implant (K093562) in terms of intended use, design, materials used and performance testing. As well as to secondary predicate - Noris Medical Dental Implant System(K140440) in terms of Internal Hex connection, packaging and sterilization.
With regards to the intended use, material, design, characteristics and dimensions, the equivalence was determined through the points in following table:
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Image /page/7/Picture/0 description: The image shows the logo for Noris Medical. The logo consists of a red square with a white diagonal line running through it, followed by the words "NORIS Medical" in red and gray. Below the words "NORIS Medical" is the phrase "ENGINEERED FOR HEALTH" in gray.
| Device Name | Southern Implants
Zygomatic Implant
(Primary Predicate) | Noris Medical
Dental Implants
system | Noris Medical
Zygomatic Dental
Implant System
(Current Submission) |
|-----------------------|-------------------------------------------------------------------------------|-------------------------------------------------------------------------------|-------------------------------------------------------------------------------|
| 510k | K093562 | K140440 | K151909 |
| Intended use | [1] | [2] | [3] |
| Patient
Population | Edentulous or partially
edentulous individuals | Edentulous or partially
edentulous individuals | Edentulous or partially
edentulous individuals |
| Material | Titanium Grade 4 | Titanium alloy | Titanium alloy |
| Diameter(mm) | 4.05 | Tuff Implant
3.3,3.75,4.2,5,6 | 4.2 |
| Length(mm) | 35, 40, 42.5, 45, 47.5,
50, 52.5, 55 | Tuff Implant Series:
6,8,10,11.5,13,16 | 35,37.5,40,42.5,45,47.
5, 50,52.5,55,57.5 |
| Abutments° | 55 | 0,15,17,25,30 | 45 |
| Surface treatment | Machined,
Oxidized surface | Sand blasted
Acid-etched | RBM(Resorbable Blast
Media) |
| Thread Design | Screw type | Tapered screw type | Tapered screw type |
| Sterility | Gamma irradiation | Gamma irradiation | Gamma irradiation |
| Clinical procedure | Immediate loading or
for loading after a
conventional healing
period | Immediate loading or
for loading after a
conventional healing
period | Immediate loading or
for loading after a
conventional healing
period |
[1] The Zygomatic implant is intended to be implanted in the upper jaw arch to provide support for fixed or removable dental prostheses in partially edentulous or full arch prostheses. It further adds the option for immediate function when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function. This implant is not intended, nor should it be used, in conjunction with an angled abutment.
[2] 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 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.
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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 words "NORIS Medical" in a bold, sans-serif font. Below the company name, the tagline "ENGINEERED FOR HEALTH" is written in a smaller, lighter font.
[3] 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 operation. All implants are appropriate for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
Noris Medical Zyqomatic Dental Implant System is intended to be implanted in the upper jaw arch to provide support for fixed or removable prosthetic devices in patients with partially of fully edentulous maxillae.
Evidence of equivalence has been demonstrated through the following: * The Noris Medical Zygomatic Dental Implant System's intended use and indications for use were previously cleared by FDA for the predicate devices.
-
The technical characteristics of the Noris Medical Dental implant System are similar to those of the predicate devices.
-
Nonclinical testing results for the Noris Medical Zygomatic Dental implants System are similar to those of the predicate devices.
Therefore, the Noris Medical Zygomatic Dental Implant System is substantially equivalent to the predicate devices in terms of intended use, materials used, and technological characteristics
4. NON-CLINICAL TESTING
The Noris Medical Zygomatic Dental Implant is manufactured from medical grade Titanium alloy per ASTM F136.
SEM and Surface analysis (EDS) after RBM process demonstrated the morphology and cleanliness of the final product.
Sterilization validation tests for the Noris Medical Dental Implants System were conducted in compliance with the following:
-
ANSI/AAMI/ISO 11137-1:06 and EN ISO 11137-2:12 and ANSI/AAMI ST79:2010 & ● A1:2010.
Biocompatibility tests were conducted in compliance with the following: -
AAMI ANSI ISO 10993-5: 2009 (R)2014 Biological evaluation of medical devices ● Part 5: Tests for in vitro cytotoxicity
-
AAMI ANSI ISO 10993-11: 2006 (R)2010 Biological evaluation of medical devices ● Part 11: Tests for systemic toxicity
Accelerated aging per ASTM-F-1980:07 has 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.
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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, followed by the text "NORIS Medical" in a dark gray sans-serif font. Below the company name, the text "ENGINEERED FOR HEALTH" is written in a smaller, lighter gray font.
Static and dynamic compression performance testing was conducted per ISO 14801: 07- Dentistry-Implants-Dynamic fatique 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".
Comparative testing was conducted according to a modified ISO 14801 set-up to account for the nominal bone level for a zygomatic dental implant design
The results of the testing indicate that the Noris Medical Zygomatic Dental Implant is substantial equivalent to the predicate devices cited in this submission.
5. CLINICAL EVALUATION
Because the subject device design represented a new technology, featuring a different threading pattern from its primary predicate, clinical testing was requested. The sponsor provided a series of retrospective, randomized clinical case studies to support the proposed device. The device was implanted in 18 patients (a total of 29 Zygomatic implants). All patients required dental extraction and immediate subject device implant replacement. The location for Zygomatic implant was usually in the upper second premolar.
The implants were placed during the years 2013 to 2014 in one clinical site in Israel, and in all 29 cases, immediate occlusal loading was employed. Patients were evaluated at a minimum of 6 months post-surgery, with the success endpoint identified as osseointegration following implant placement. Computed Tomography (CT) was taken Pre-op. Panoramic radiographs were taken Pre-op, immediately after implantation and after at least 6 month follow up.
In the clinical study report, the sponsor presented long-term results of several patients implanted with the subject device. A success rate of 96% was obtained after at least 6 months follow up. Those results correspond to the CSR (Cumulative Success Rate) reported worldwide by the sponsor for Zygomatic dental implants.
6. CONCLUSION
The results of the testing conducted on the Noris Medical Zygomatic Dental Implant System demonstrated that the system is substantially equivalent to the predicate devices in terms of functional, mechanical properties, indications for use and material.