(133 days)
No
The summary describes a physical dental implant system made of titanium alloy, with no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is intended to replace missing teeth and restore chewing function, which can be considered therapeutic as it addresses a health-related issue.
No
Explanation: The device is a dental implant system designed to replace missing teeth and support prosthetic devices. Its function is to restore chewing function, not to provide diagnostic information about a patient's condition.
No
The device description clearly details physical components made of Titanium alloy, such as implants, healing caps, abutments, and screws. There is no mention of software as the primary or sole component.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for replacing missing teeth and supporting prosthetic devices to restore chewing function. This is a direct therapeutic and restorative purpose within the body.
- Device Description: The description details the physical components of a dental implant system (implants, healing caps, abutments, screws) made of titanium alloy. These are all physical devices intended for surgical implantation and mechanical support.
- Lack of IVD Characteristics: An IVD is a medical device intended to be used in vitro for the examination of specimens, including blood and tissue samples, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to monitor therapeutic measures. The provided text does not mention any of these activities. There is no mention of analyzing samples, providing diagnostic information, or monitoring physiological states through in vitro testing.
Therefore, the Noris Medical Ltd. Conical Platform Dental Implants System is a medical device used for surgical implantation and prosthetic support, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Noris Medical Ltd. Conical Platform 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.
Noris Medical Ltd. Conical platform Dental Implants diameter 3.25 are intended to replace lateral incisor in Maxilla and/or a central or lateral incisor in the mandible 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 impants are appropriate for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
Product codes
DZE, NHA
Device Description
-
a) Dental Implants- 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 UniCon and Tuff Unicon Implants are designed with conical connection comprises of cone and internal hex connection, diameters of 3.25, 3.5, 3.75 and 4.2 mm and lengths of 8, 10, 11.5, 13, 16 and 18 mm. Both Implants are designed with three thread zones, the Tuff UniCon with lower V-shape thread zone and UniCon with sharp buttress threads enables self-tapping. The middle zone square type thread of Tuff UniCon and wide edge buttress of UniCon is used for compressing cancellous bone. The micro threads on the upper zone enables less pressure on the crestal bone. The subject devices undergo RBM (Resorbable Blasting Media) surface treatment and color anodization within its connection for the purpose of color coding. It is indicated to replace missing tooth/teeth in either jaw for supporting prosthetic devices that may aid in restoring the patient's chewing function. The Implants Diameter Ø3.25 are intended to replace lateral incisor in maxilla and/or a central or lateral incisor in the mandible for supporting prosthetic devices that may aid in restoring the patient's chewing function.
-
Healing Cap Healing Caps are Titanium devices mounted onto the dental implant b) before the soft tissue is sutured around the implant and are intended to protect the implant bore. The Subject Healing Cap with the conical connection fits the UniCon and Tuff Unicon Implants. It is single use device, non-sterile and made of Titanium alloy Ti- 6Al-4V ELI (ASTM F136). The Healing Cap provided with 4.3mm, 4.8mm and 5.2mm Diameter and 4.5mm, 5.5mm, 6.5m, 7.5mm, 8.5mm External Body Height. The subject device undergoes color anodization.
-
c) Abutments (temporary, straight, angular and screw retained)- The Subject Abutments with the conical connection fits the UniCon and Tuff UniCon Implants. It is single use device, non-sterile and made of Titanium alloy Ti- 6Al-4V ELI (ASTM F136). The subject device undergoes color anodization. The abutments are provided in different types and dimensions; The straight abutment is used in the fabrication of cement-retained restorations, single crowns or bridges. Straight abutments with shoulder are provided with 4.5mm Diameter and 9mm, 10mm, 11mm,12mm External Body Height. Straight abutments are provided with 5mm Diameter and 9mm, 12mm External Body Height. Angular abutments are used when a change to the axis of the implant is required. Normally used for constructing cement-retained single crowns or bridges. Angular Abutment are provided with 4.1mm, 4.4mm Diameter and 9mm, 11mm External Body Height and 15° and 25° degrees angle. The Flat attachment superstructure is intended to secure an overdenture. Flat attachments are provided with 3.87 mm diameter and are suitable for gingival heights* of 0.5mm, 1mm, 2mm, 3mm, 4mm, and 5mm. Temporary Titanium Abutments are screwed into the dental implants. They serve as a base for a temporary prosthetic restoration. Non-engage Temporary abutment and Temporary abutment are provided with 4.3mm Diameter and 9.5mm External Body Height.
-
Multi-Unit Straight/Angular Screw Retained abutment- Multi-Unit Abutments are d) intended to function in the mandible or maxilla to support multiple-unit temporary or permanent restorations on Noris dental implants. The Subject Abutments with the conical connection fits the UniCon and Tuff UniCon Implants. It is single use device, non-sterile and made of Titanium alloy Ti- 6Al-4V ELI (ASTM F136). The subject device undergoes color anodization. The Multi-Unit straight Screw Retained abutments are provided with 4.9mm Diameter and 1.5mm, 3.5mm, 4.5mm, 5.5mm Collar Height and the Multi-Unit Angular Screw Retained abutments are provided with 4.9mm Diameter and 2mm, 2.5mm Gingival Height and 17, 30 degrees angle.
-
Abutments screw- The abutment screw is intended to fasten the abutment to a e) dental implant. The Subject Abutments screw with the conical connection fits the UniCon and Tuff UniCon Implants. It is single use device, non-sterile and made of Titanium alloy Ti- 6Al-4V ELI (ASTM F136). The Abutments screw provided with 2mm Diameter and 7.3 mm Length. The subject device undergoes color anodization.
-
Cover screw- Healing Caps and Cover Screws are Titanium devices mounted onto the f) dental implant before the soft tissue is sutured in place around the implant and which are intended to protect the implant bore. The Subject Cover screw with the conical connection fits the UniCon and Tuff Unicon Implants. It is single use device, non-sterile and made of Titanium alloy Ti- 6Al-4V ELI (ASTM F136). The cover screws are provided with 3.2mm, 3.5mm Diameters and 4.9 mm Length. The subject device undergoes color anodization.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
either jaw, Maxilla, mandible
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 UniCon implants, according to FDA Guidance.
The subject implant devices undergo RBM (Resorbable Blasting Media) surface treatment and color anodization within its connection for the purpose of color coding. The Prosthetic device and screws undergoes Gold anodization process. Non- clinical worst-case Biocompatibility leverage was performed since the material, manufacturing, and surface treatments are identical to the material, manufacturing, and surface treatments used to manufacture dental implants cleared in K151909.
Non-clinical worst-case Reprocessing sterilization for the subject prosthetic device and screws and sterilization for subject devices Implants was leveraged since the material and design is the same as previously cleared devices in K140440.
Pyrogen limits specifications are monitored at set intervals. Test was leveraged since there is no change from previously cleared devices in K140440.The method used to make the determination that the device meets pyrogen limits specifications is based on USP .
Non-clinical worst-case MRI review was performed to evaluate the metallic Noris Medical's Conical Platform Dental Implants System, UniCon, Tuff UniCon in the MRI environment using scientific rationale and published literature (e.g., Woods, Terry 0., 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 including all variations (all compatible implant bodied, dental abutments and, fixation screws) and material composition. 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 shows the logo for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: on the left, there is a symbol representing the Department of Health & Human Services, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The text is arranged in two lines, with "FDA" being larger and bolder than the rest of the text.
Noris Medical Ltd. Noa Mor Regulatory Affairs Director 8 Hataasia St. Nesher, 3688808 ISRAEL
June 6, 2024
Re: K240202
Trade/Device Name: Conical Platform Dental Implants System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: May 7, 2024 Received: May 7, 2024
Dear Noa Mor:
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.
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-regulatory-
assistance/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)
K240202
Device Name
Conical Platform Dental Implants System
Noris Medical Ltd. Conical Platform Dental Implants System id intended to replace missing tooth/teeth in either jaw for supporting prosthetic devices that may aid in restoring the patient's chewing function.
Noris Medical Ltd. Conical platform Dental Implants diameter 3.25 are intended to replace lateral incisor in Maxilla and/or a central or lateral incisor in the mandible 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 impants are appropriate for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
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/0 description: The image contains 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. Below the text is the phrase "Dental Implant Solutions" in a smaller, lighter gray font. The logo is clean and professional, suggesting a focus on medical and dental products.
510k Summary (K240202)
l. SUBMITTER
Noris Medical Ltd. 8 Hataasia St. 3688808 Nesher, Israel
Phone: 972-73-7964477
Contact Person: Noa Mor Date Prepared: June 05, 2024
II. DEVICE
Name of Device: Conical Platform Dental Implants System Common or Usual Name: Conical Platform Dental Implants System Classification Name: Endosseous dental implant (21 CFR 872.3640) Regulatory Class: II Product Code: DZE Associated Product Code: NHA
PREDICATE AND REFERENCE DEVICES lll.
Noris Medical Ltd. - Tuff (K140440 Primary Predicate) Nobel Biocare – NobelActive ® (NP-Narrow Platform) (K142260 Reference Device) Paltop Advanced Dental Solutions Ltd. - PCA (NP- Narrow Platform) (K130462 Reference Device)
Noris Medical Ltd. - Zygomatic Implants (K151909 Reference Device for Biocompatibility)
IV. DEVICE DESCRIPTION
- a) Dental Implants- 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 UniCon and Tuff Unicon Implants are designed with conical connection comprises of cone and internal hex connection, diameters of 3.25, 3.5, 3.75 and 4.2 mm and lengths of 8, 10, 11.5, 13, 16 and 18 mm. Both Implants are designed with three thread zones, the Tuff UniCon with lower V-shape thread zone and UniCon with sharp buttress threads enables self-tapping. The middle zone square type thread of Tuff UniCon and wide edge buttress of UniCon is used for compressing cancellous bone. The micro threads on the upper zone enables less pressure on the crestal bone. The subject devices undergo RBM (Resorbable Blasting Media) surface treatment and color anodization within its connection for the purpose of color coding. It is indicated to replace missing tooth/teeth in either jaw for supporting prosthetic devices that may aid in restoring the patient's chewing function. The Implants Diameter Ø3.25 are intended to replace lateral incisor in maxilla and/or a
5
Dental Implant Solution
central or lateral incisor in the mandible for supporting prosthetic devices that may aid in restoring the patient's chewing function.
- Healing Cap Healing Caps are Titanium devices mounted onto the dental implant b) before the soft tissue is sutured around the implant and are intended to protect the implant bore. The Subject Healing Cap with the conical connection fits the UniCon and Tuff Unicon Implants. It is single use device, non-sterile and made of Titanium alloy Ti- 6Al-4V ELI (ASTM F136). The Healing Cap provided with 4.3mm, 4.8mm and 5.2mm Diameter and 4.5mm, 5.5mm, 6.5m, 7.5mm, 8.5mm External Body Height. The subject device undergoes color anodization.
- c) Abutments (temporary, straight, angular and screw retained)- The Subject Abutments with the conical connection fits the UniCon and Tuff UniCon Implants. It is single use device, non-sterile and made of Titanium alloy Ti- 6Al-4V ELI (ASTM F136). The subject device undergoes color anodization. The abutments are provided in different types and dimensions; The straight abutment is used in the fabrication of cement-retained restorations, single crowns or bridges. Straight abutments with shoulder are provided with 4.5mm Diameter and 9mm, 10mm, 11mm,12mm External Body Height. Straight abutments are provided with 5mm Diameter and 9mm, 12mm External Body Height. Angular abutments are used when a change to the axis of the implant is required. Normally used for constructing cement-retained single crowns or bridges. Angular Abutment are provided with 4.1mm, 4.4mm Diameter and 9mm, 11mm External Body Height and 15° and 25° degrees angle. The Flat attachment superstructure is intended to secure an overdenture. Flat attachments are provided with 3.87 mm diameter and are suitable for gingival heights* of 0.5mm, 1mm, 2mm, 3mm, 4mm, and 5mm. Temporary Titanium Abutments are screwed into the dental implants. They serve as a base for a temporary prosthetic restoration. Non-engage Temporary abutment and Temporary abutment are provided with 4.3mm Diameter and 9.5mm External Body Height.
- Multi-Unit Straight/Angular Screw Retained abutment- Multi-Unit Abutments are d) intended to function in the mandible or maxilla to support multiple-unit temporary or permanent restorations on Noris dental implants. The Subject Abutments with the conical connection fits the UniCon and Tuff UniCon Implants. It is single use device, non-sterile and made of Titanium alloy Ti- 6Al-4V ELI (ASTM F136). The subject device undergoes color anodization. The Multi-Unit straight Screw Retained abutments are provided with 4.9mm Diameter and 1.5mm, 3.5mm, 4.5mm, 5.5mm Collar Height and the Multi-Unit Angular Screw Retained abutments are provided with 4.9mm Diameter and 2mm, 2.5mm Gingival Height and 17, 30 degrees angle.
- Abutments screw- The abutment screw is intended to fasten the abutment to a e) dental implant. The Subject Abutments screw with the conical connection fits the UniCon and Tuff UniCon Implants. It is single use device, non-sterile and made of Titanium alloy Ti- 6Al-4V ELI (ASTM F136). The Abutments screw provided with 2mm Diameter and 7.3 mm Length. The subject device undergoes color anodization.
- Cover screw- Healing Caps and Cover Screws are Titanium devices mounted onto the f) dental implant before the soft tissue is sutured in place around the implant and which are intended to protect the implant bore. The Subject Cover screw with the conical connection fits the UniCon and Tuff Unicon Implants. It is single use device, non-sterile and made of Titanium alloy Ti- 6Al-4V ELI (ASTM F136). The cover screws
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Image /page/6/Picture/0 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 words "NORIS Medical" in gray. Below "NORIS Medical" is the text "Dental Implant Solutions" in a smaller, lighter gray font. The logo is clean and modern, with a focus on the company's name and its specialization in dental implants.
are provided with 3.2mm, 3.5mm Diameters and 4.9 mm Length. The subject device undergoes color anodization.
*Flat Attachment gingival height - the distance from the flat coronal surface of implants with diameters of 3.5 mm, 3.75 mm, and 4.2 mm, measured up to 0.5 mm below the metal cap of the flat attachment. For implants with a diameter of 3.25 mm, this distance is 0.86 mm below the metal cap of the flat attachment.
INDICATION FOR USE V.
Noris Medical Ltd Conical Platform 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 .
Noris Medical Ltd Conical Platform Dental Implants diameter Ø3.25 are intended to replace lateral incisor in maxilla and/or a central or lateral incisor in the mandible 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.
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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 words "NORIS Medical" in gray on the right. Below "NORIS Medical" is the text "Dental Implant Solutions" in a lighter gray color. There is a registered trademark symbol next to the word Medical.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS VI.
- a. Dental Implants
| SUBJECT DEVICE | SUBJECT DEVICE | PRIMARY PREDICATE | REFERENCE PREDICATE | REFERENCE PREDICATE | |
|---|---|---|---|---|---|
| Device | UniCon | Tuff UniCon | Tuff | ||
| (K140440) | NobelActive ® | ||||
| (K142260) | PCA | ||||
| (K130462) | |||||
| Noris Medical Ltd. | Noris Medical Ltd. | Noris Medical Ltd. | Nobel Biocare AB | Paltop Advanced Dental Solutions | |
| Ltd. | |||||
| Design Description | Threaded root-form implant to be | ||||
| used with matching abutments. | Threaded root-form implant to be | ||||
| used with matching abutments. | Threaded root-form implant to be used | ||||
| with matching abutments. | Threaded root-form implant to be | ||||
| used with matching abutments. | Threaded root-form implant to be | ||||
| used with matching abutments. | |||||
| Indication for Use | Noris Medical Ltd Conical | ||||
| Platform 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. | |||||
| Noris Medical Ltd. Conical | |||||
| Platform Implants diameter Ø3.25 | |||||
| are intended to replace lateral | |||||
| incisor in maxilla and/or a central | |||||
| or lateral incisor in the mandible | |||||
| 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 Ltd Conical Platform | ||||
| 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. | |||||
| Noris Medical Ltd.Conical Platform | |||||
| Implants diameter Ø3. 25 are | |||||
| intended to replace lateral incisor in | |||||
| maxilla and/or a central or lateral | |||||
| incisor in the mandible 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 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. | NobelActive ® implants are | ||||
| endosseous implants intended to | |||||
| be surgically placed in the upper | |||||
| or lower jaw bone for anchoring or | |||||
| supporting tooth replacements to | |||||
| restore patient esthetics and | |||||
| chewing function. NobelActive ® | |||||
| implants are indicated for single or | |||||
| multiple unit restorations in | |||||
| splinted or non-splinted | |||||
| applications. This can be achieved | |||||
| by a 2-stage or 1-stage surgical | |||||
| technique in combination with | |||||
| immediate, early or delayed | |||||
| loading protocols, recognizing | |||||
| sufficient primary stability and | |||||
| appropriate occlusal loading for | |||||
| the selected technique. | |||||
| NobelActive® 3.0 implants are | |||||
| intended to replace a lateral | |||||
| incisor in the maxilla and/or a | |||||
| central or lateral incisor in the | |||||
| mandible. | |||||
| NobelActive® 3.0 implants are | |||||
| indicated for single unit | |||||
| restorations only. | The Paltop Narrow implant is | ||||
| indicated for use in surgical and | |||||
| restorative applications for | |||||
| placement in the mandibular | |||||
| central, lateral incisor and | |||||
| maxillary lateral incisor regions of | |||||
| partially edentulous jaws where | |||||
| the horizontal space is limited by | |||||
| the adjacent teeth and roots, to | |||||
| provide support for prosthetic | |||||
| devices, such as artificial teeth, in | |||||
| order to restore the patient's | |||||
| chewing function. The Paltop | |||||
| narrow implant is indicated also for | |||||
| immediate loading when good | |||||
| primary stability is achieved and | |||||
| with appropriate occlusal loading |
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Image /page/8/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 gray. Below the company name, the text "Dental Implant Solutions" is written in a smaller, lighter gray font.
| SUBJECT DEVICE | SUBJECT DEVICE | PRIMARY PREDICATE | REFERENCE PREDICATE | REFERENCE PREDICATE | |
|---|---|---|---|---|---|
| Device | UniCon | Tuff UniCon | Tuff | ||
| (K140440) | NobelActive ® | ||||
| (K142260) | PCA | ||||
| (K130462) | |||||
| Noris Medical Ltd. | Noris Medical Ltd. | Noris Medical Ltd. | Nobel Biocare AB | Paltop Advanced Dental Solutions | |
| Ltd. | |||||
| Type | Bone level Implant | Bone level Implant | Bone level Implant | Bone level Implant | Bone level Implant |
| Implant Diameter [mm] | Ø 3.5 | ||||
| Ø 3.75 | |||||
| Ø 4.2 | Ø 3.25 | ||||
| Ø 3.5 | |||||
| Ø 3.75 | |||||
| Ø 4.2 | Ø 3.75 | ||||
| Ø 4.2 | Ø 3.5 | ||||
| Ø 4.3 | Ø 3.25 | ||||
| Length [mm] | 8, 10, 11.5, 13, 16,18 | 10, 11.5, 13, 16 For Ø3.25 | |||
| 8, 10, 11.5, 13, 16, 18 for Ø3.5, | |||||
| Ø3.75, Ø4.2 | 8, 10, 11.5, 13, 16,18 | 8.5, 10, 11.5, 13, 15,18 | 10, 11.5, 13, 16 | ||
| Material | Titanium alloy Grade 23 | ||||
| Ti-6Al-4V ELI | Titanium alloy Grade 23 | ||||
| Ti-6Al-4V ELI | Titanium alloy Grade 23 | ||||
| Ti-6Al-4V ELI | Commercially Pure Titanium | ||||
| Grade 4 | Titanium alloy Grade 23 | ||||
| Ti-6Al-4V ELI | |||||
| Surface Treatment | RBM (Resorbable Blasting Media) | RBM (Resorbable Blasting Media) | RBM (Resorbable Blasting Media) | TiUnite | Sand blasted and acid etched |
| 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/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 words "NORIS Medical" in gray. Below the company name, the words "Dental Implant Solutions" are written in a smaller font, also in gray.
b. Healing Cap
| SUBJECT DEVICE | PRIMARY PREDICATE | REFERENCE PREDICATE | |
|---|---|---|---|
| Device | Healing Cap | ||
| Conical Platform | Healing Cap | ||
| Internal Hex (Standard Platform) | |||
| (K140440) | Nobel Active® Healing Abutments | ||
| Bridge | |||
| Conical | |||
| Connection NP | |||
| (Narrow | |||
| Platform) | |||
| (K142260) | |||
| Noris Medical Ltd. | Noris Medical Ltd. | Nobel Biocare AB | |
| Design Description | Cylindrical shape with concave | ||
| emergence profile body. | |||
| Free-rotation (non-engage) with | |||
| integrated screw portion to thread | |||
| directly to the implant. | |||
| Interface the implant upper face. | Cylindrical shape body. | ||
| Free-rotation (non-engage) with integrated | |||
| screw portion to thread directly to the | |||
| implant. | |||
| Interface the implant internal connection | |||
| cone. | Cylindrical shape with concave | ||
| emergence profile body. | |||
| Free-rotation (non-engage) with | |||
| integrated screw portion to thread | |||
| directly to the implant. | |||
| Interface the implant upper face. | |||
| Material | Titanium alloy Ti-6Al-4V ELI | Titanium alloy Ti-6Al-4V ELI | Titanium alloy |
| Color | Gold Anodize | No Color | Partial Pink Anodize |
| Diameter | 4.3, 4.8, 5.2 | 3.8, 4.6, 5.5, 6.3 | 4 |
| External Body Height* | |||
| [mm] | 4.5, 5.5, 6.5, 7.5, 8.5 | ||
| For Ø4.3, Ø5.2 | |||
| 4.5, 5.5, 6.5, 7.5 | |||
| For Ø4.8 | 2, 3, 4, 5, 6, 7 | 3, 5, 7 | |
| Angle [°] | 0 | 0 | 0 |
| Sterilization | Non sterile | Non sterile | Sterile |
| Single Use | Yes | Yes | Yes |
- External Body Height - The height from implant most coronal surface
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Image /page/10/Picture/0 description: The image contains 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. Below that, the text "Dental Implant Solutions" is also in gray and in a smaller font size.
ﻥ Straight abutment
| SUBJECT DEVICE | PRIMARY PREDICATE | REFERENCE PREDICATE | |
|---|---|---|---|
| Device | Straight abutment with shoulder | ||
| Conical Platform | Straight abutment with shoulder | ||
| Internal Hex (Standard Platform) | |||
| (K140440) | Nobel Active Snappy Abutments | ||
| Conical Connection NP (Narrow | |||
| Platform) | |||
| (K142260) | |||
| Noris Medical Ltd. | Noris Medical Ltd. | Nobel Biocare AB | |
| Design Description | Anti-rotation products that | ||
| interface the internal connection of | |||
| the implant and include cone and | |||
| hexagon (to engage the implant). | |||
| Shoulder in various heights. | |||
| These products include dedicated | |||
| screw to connect to the implant. | Anti-rotation products that interface the | ||
| internal connection of the implant and | |||
| include cone and hexagon (to engage the | |||
| implant). Shoulder in various heights. | |||
| These products include dedicated screw to | |||
| connect to the implant. | Anti-rotation products that | ||
| interface the internal connection of | |||
| the implant and include cone and | |||
| hexagon (to engage the implant). | |||
| These products include dedicated | |||
| screw to connect to the implant. | |||
| Material | Titanium alloy Ti-6Al-4V ELI | Titanium alloy Ti-6Al-4V ELI | Titanium alloy |
| Color | Gold Anodize | No Color | Partial Pink Anodize |
| Diameter | 4.5 | 4.5, 5.5 | 4, 5.5 |
| External Body Height* | |||
| [mm] | 9,12 | 8.5, 9, 9.5, 10.5, 11, 11.5, 12.5 | 5.5, 7, 8.5 |
| Angle [°] | 0 | 0 | 0 |
| Sterilization | Non sterile | Non sterile | Sterile |
| Single Use | Yes | Yes | Yes |
- External Body Height- The height from implant platform (for 3.5,3.75 and 4.2 diameter implants)
d. Angular Abutment
| SUBJECT DEVICE | PRIMARY PREDICATE | REFERENCE PREDICATE | |
|---|---|---|---|
| Device | Angular abutment | ||
| Conical Platform | Angular abutment | ||
| Internal Hex (Standard Platform) | |||
| (K140440) | Nobel Active 15° Esthetic Abutments | ||
| Conical Connection NP (Narrow | |||
| Platform) | |||
| (K142260) | |||
| Noris Medical Ltd. | Noris Medical Ltd. | Nobel Biocare AB | |
| Design Description | Anti-rotation products that interface | ||
| the internal connection of the | |||
| implant and include cone and | |||
| hexagon (to engage the implant). | Anti-rotation products that interface the | ||
| internal connection of the implant and | |||
| include cone and hexagon (to engage the | |||
| implant). | Anti-rotation products that interface | ||
| the internal connection of the | |||
| implant and include cone and | |||
| hexagon (to engage the implant). | |||
| Material | Titanium alloy Ti-6Al-4V ELI | Titanium alloy Ti-6Al-4V ELI | Titanium alloy |
| Color | Gold Anodize | No Color | Partial Pink Anodize |
| Diameter | 4.1, 4.4 | 4, 4.5 | Not published |
| External Body Height* | |||
| [mm] | 9,11 | 9, 11 | 8, 9.5, 11 |
| Angle [°] | 15, 25 | 15, 25 | 15 |
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Image /page/11/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 words "NORIS Medical" in gray. Below "NORIS Medical" are the words "Dental Implant Solutions" in a smaller font, also in gray. The logo is clean and modern, with a focus on the company's name and its specialization in dental implants.
| Device | SUBJECT DEVICE | PRIMARY PREDICATE | REFERENCE PREDICATE |
|---|---|---|---|
| Angular abutment | |||
| Conical Platform | Angular abutment | ||
| Internal Hex (Standard Platform) | |||
| (K140440) | Nobel Active 15° Esthetic Abutments | ||
| Conical Connection NP (Narrow | |||
| Platform) | |||
| (K142260) | |||
| Noris Medical Ltd. | Noris Medical Ltd. | Nobel Biocare AB | |
| Sterilization | Non sterile | Non sterile | Sterile |
| Single Use | Yes | Yes | Yes |
- External Body Height- The height from implant platform (for 3.5,3.75 and 4.2 diameter implants)
e. Multi-Unit Angular/Straight Screw Retained abutment
ල
| SUBJECT DEVICE | PRIMARY PREDICATE | REFERENCE PREDICATE | |
|---|---|---|---|
| Device | Multi-Unit Straight Screw Retained | ||
| abutment | |||
| Conical Platform | Multi-Unit Straight Screw Retained abutment | ||
| Internal Hex (Standard Platform) | |||
| (K140440) | Nobel Active Multi-Unit Abutment | ||
| Conical Connection NP (Narrow Xeal | |||
| Platform) | |||
| (K142260) | |||
| Noris Medical Ltd. | Noris Medical Ltd. | Nobel Biocare AB | |
| Design Description | Screw retained shape with concave | ||
| emergence profile body. | |||
| Free-rotation (non-engage) with | |||
| integrated screw portion to thread | |||
| directly to the implant. | |||
| Screw retained restorative portion | |||
| with hexagon, cone and internal | |||
| thread. | |||
| Interface the implant internal | |||
| connection cone. | Screw retained shape with concave | ||
| emergence profile body. | |||
| Free-rotation (non-engage) with integrated | |||
| screw portion to thread directly to the | |||
| implant. | |||
| Screw retained restorative portion with | |||
| hexagon, cone and internal thread. | |||
| Interface the implant internal connection | |||
| cone. | Screw retained shape with concave | ||
| emergence profile body. | |||
| Free-rotation (non-engage) with | |||
| integrated screw portion to thread | |||
| directly to the implant. | |||
| Screw retained restorative portion | |||
| with hexagon, cone and internal | |||
| thread. | |||
| Interface the implant internal | |||
| connection cone. | |||
| Material | Titanium alloy Ti-6Al-4V ELI | Titanium alloy Ti-6Al-4V ELI | Titanium alloy |
| Color | Gold Anodize | No Color | Gold Anodize |
| Diameter | 4.9 | 4.9 | 4.9 |
| Gingival Height [mm] | Angular: 2, 2.5, 3.5 | ||
| Straight: 1.5, 2.5, 3.5, 4.5, 5.5 | Angular: 2, 3, 4, 5 | ||
| Straight: 1, 2, 3, 4, 5 | Angular: 2.5, 3.5, 4.5 | ||
| Straight: 1.5, 2.5, 3.5 | |||
| Angle [°] | 0, 17, 30 | 0, 17, 30 | 0, 17, 30 |
| Sterilization | Non sterile | Non sterile | Sterile |
| Single Use | Yes | Yes | Yes |
ﺖ Flat Attachment
| Device | SUBJECT DEVICE | PRIMARY PREDICATE | REFERENCE PREDICATE |
|---|---|---|---|
| Flat Attachment | |||
| Conical Platform | Flat Attachment | ||
| Internal Hex (Standard Platform) | |||
| (K140440) | Device - LOCATOR® Implant | ||
| Attachment System | |||
| (K083324) | |||
| Noris Medical Ltd. | Noris Medical Ltd. | ZEST ANCHORS, INC. |
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Image /page/12/Picture/0 description: The image contains the logo for NORIS Medical Dental Implant Solutions. The logo consists of a red abstract shape resembling the letter 'N' on the left, followed by the text "NORIS Medical" in gray. Below "NORIS Medical" is the text "Dental Implant Solutions" in a smaller gray font. The logo is clean and modern, suggesting a company in the medical or dental field.
| SUBJECT DEVICE | PRIMARY PREDICATE | REFERENCE PREDICATE | |
|---|---|---|---|
| Device | Flat Attachment | ||
| Conical Platform | Flat Attachment | ||
| Internal Hex (Standard Platform) | |||
| (K140440) | Device - LOCATOR® Implant | ||
| Attachment System | |||
| (K083324) | |||
| Noris Medical Ltd. | Noris Medical Ltd. | ZEST ANCHORS, INC. | |
| Design Description | Cylindrical shape with concave | ||
| emergence profile body. | |||
| Free-rotation (non-engage) with | |||
| integrated screw portion to thread | |||
| directly to the implant. | |||
| Interface the internal connection of | |||
| the implant cone. | |||
| Attachment head to connect to | |||
| overdenture metal house with | |||
| retentive elastomer cap. | Cylindrical shape with concave emergence | ||
| profile body. | |||
| Free-rotation (non-engage) with integrated | |||
| screw portion to thread directly to the | |||
| implant. | |||
| Interface the internal connection of the | |||
| implant cone. | |||
| Attachment head to connect to overdenture | |||
| metal house with retentive elastomer cap. | Cylindrical shape with concave | ||
| emergence profile body. | |||
| Free-rotation (non-engage) with | |||
| integrated screw portion to thread | |||
| directly to the implant. | |||
| Interface the internal connection of | |||
| the implant cone. | |||
| Attachment head to connect to | |||
| overdenture metal house with | |||
| retentive elastomer cap. | |||
| Material | Titanium alloy Ti-6Al-4V ELI | Titanium alloy Ti-6Al-4V ELI | Titanium alloy |
| Color | Gold Anodize | No Color | Partial Gold Anodize |
| Diameter | 3.87 | 3.87 | 3.87 |
| Gingival Height* [mm] | 0.5, 1, 2, 3, 4, 5 | 0.5, 1, 2, 3, 4, 5 | 1, 2, 3, 4, 5, 6 |
| Angle [°] | 0 | 0 | 0 |
| Sterilization | Non sterile | Non sterile | Sterile |
| Single Use | Yes | Yes | Yes |
- Flat attachments Gingival Height- Distance from the flat coronal surface of implants with diameters of 3.5mm,
3.75mm, and 4.2mm, measured up to 0.5mm below the metal cap of the flat attachment.
For implants with a diameter of 3.25mm, this distance is 0.86 mm below the metal cap of the flat attachment.
g. Temporary abutment
| Device | SUBJECT DEVICE | PRIMARY PREDICATE | REFERENCE PREDICATE |
|---|---|---|---|
| Non-engage Temporary | |||
| abutment/Temporary Abutment | |||
| Conical Platform | Non-engage Temporary abutment/ | ||
| Temporary Abutment | |||
| Internal Hex (Standard Platform) | |||
| (K140440) | Nobel Active Temporary Abutment | ||
| Nobel Biocare N1™ TCC Conical | |||
| Connection NP (Narrow Platform) | |||
| (K142260) | |||
| Noris Medical Ltd. | Noris Medical Ltd. | ZEST ANCHORS, INC. | |
| Design Description | Free-rotation (non-engage). | ||
| Interface the internal connection of | |||
| the implant cone. | |||
| The product includes dedicated | |||
| screw to connect to the implant. | Free-rotation (non-engage). | ||
| Interface the internal connection of the | |||
| implant cone. | |||
| The product includes dedicated screw to | |||
| connect to the implant. | Free-rotation (non-engage). | ||
| Interface the internal connection of | |||
| the implant cone. | |||
| The product includes dedicated screw | |||
| to connect to the implant. | |||
| Material | Titanium alloy Ti-6Al-4V ELI | Titanium alloy Ti-6Al-4V ELI | Titanium alloy |
| Color | Gold Anodize | No Color | Gold Anodize / Partial Pink |
| Anodize | |||
| Diameter | 4.3 | 4.4 | Not published |
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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 gray. Below "NORIS Medical" is the text "Dental Implant Solutions" also in gray.
| Device | SUBJECT DEVICE | PRIMARY PREDICATE | REFERENCE PREDICATE |
|---|---|---|---|
| Non-engage Temporary | |||
| abutment/Temporary Abutment | |||
| Conical Platform | Non-engage Temporary abutment/ | ||
| Temporary Abutment | |||
| Internal Hex (Standard Platform) | |||
| (K140440) | Nobel Active Temporary Abutment | ||
| Nobel Biocare N1™ TCC Conical | |||
| Connection NP (Narrow Platform) | |||
| (K142260) | |||
| Noris Medical Ltd. | Noris Medical Ltd. | ZEST ANCHORS, INC. | |
| External Body Height* | |||
| [mm] | 9.5 | 9/ 9.5 | 10 |
| Angle [°] | 0 | 0 | 0 |
| Sterilization | Non sterile | Non sterile | Sterile |
| Single Use | Yes | Yes | Yes |
- External Body Height- The height from implant platform (for 3.5,3.75 and 4.2 diameter implants)
h. Cover screw / Abutment screw
| SUBJECT DEVICE | PRIMARY PREDICATE | REFERENCE PREDICATE | |
|---|---|---|---|
| Device | Cover screw/ Abutment Screw | ||
| Conical Platform | Cover screw/ Abutment Screw Internal Hex | ||
| (Standard Platform) | |||
| (K140440) | Cover Screw | ||
| Conical Connection NP/ Multi-Unit | |||
| Abutment Screw (Narrow Platform) | |||
| (K142260) | |||
| Noris Medical Ltd. | Noris Medical Ltd. | ZEST ANCHORS, INC. | |
| Design Description | Screw | ||
| Free-rotation (non-engage) with | |||
| integrated screw portion to thread | |||
| directly to the implant. | |||
| Interface the implant upper face. | Screw | ||
| Free-rotation (non-engage) with integrated | |||
| screw portion to thread directly to the | |||
| implant. | |||
| Interface the implant upper face. | Screw | ||
| Free-rotation (non-engage) with | |||
| integrated screw portion to thread | |||
| directly to the implant. | |||
| Interface the implant upper face. | |||
| Material | Titanium alloy Ti-6Al-4V ELI | Titanium alloy Ti-6Al-4V ELI | Titanium alloy |
| Color | Gold Anodize | Blue Anodize | Pink/Purple Anodize/ dark coating |
| Diameter | Cover screws: 3.2, 3.5 | Cover screws: 3.8 | Cover screws: 3 |
| Abutment screws: 2 | Abutment screws: 2.1 | Abutment screws: not published | |
| Length [mm] | Cover screws: 4.9 | Cover screws: 5 | Cover screws: not published |
| Abutment screws: 7.3 | Abutment screws: 8.3 | Abutment screws: not published | |
| Angle [°] | 0 | 0 | 0 |
| Sterilization | Non sterile | Non sterile | Sterile |
| Single Use | Yes | Yes | Yes |
VII. PERFORMANCE DATA
Fatigue tests per ISO 14801 were performed to determine the fatigue strength for UniCon implants, according to FDA Guidance.
The subject implant devices undergo RBM (Resorbable Blasting Media) surface treatment and color anodization within its connection for the purpose of color coding. The Prosthetic
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Image /page/14/Picture/0 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. Below the text "NORIS Medical" is the text "Dental Implant Solutions" in a smaller font size and also in gray. The logo is simple and modern, and it is likely used to represent the company's brand.
device and screws undergoes Gold anodization process. Non- clinical worst-case Biocompatibility leverage was performed since the material, manufacturing, and surface treatments are identical to the material, manufacturing, and surface treatments used to manufacture dental implants cleared in K151909.
Non-clinical worst-case Reprocessing sterilization for the subject prosthetic device and screws and sterilization for subject devices Implants was leveraged since the material and design is the same as previously cleared devices in K140440.
Pyrogen limits specifications are monitored at set intervals. Test was leveraged since there is no change from previously cleared devices in K140440.The method used to make the determination that the device meets pyrogen limits specifications is based on USP .
Non-clinical worst-case MRI review was performed to evaluate the metallic Noris Medical's Conical Platform Dental Implants System, UniCon, Tuff UniCon in the MRI environment using scientific rationale and published literature (e.g., Woods, Terry 0., 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 including all variations (all compatible implant bodied, dental abutments and, fixation screws) and material composition. 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.
VIII. 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.
Thus, the subject devices have been demonstrated to be substantially equivalent to the predicate device.