(361 days)
No
The summary describes a system of dental implants and abutments, focusing on mechanical properties, biocompatibility, and clinical outcomes. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is intended to replace missing teeth and support prosthetic devices that aid in restoring a patient's chewing function, which is a therapeutic purpose.
No
The Noris Medical Dental Implants System is intended to replace missing teeth and support prosthetic devices, rather than to diagnose medical conditions.
No
The device description explicitly states that the system includes physical components like abutments, extenders, and screws, which are manufactured from Titanium alloy. This indicates it is a hardware device, not software-only.
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 screws, which are physical components implanted into the jawbone.
- Lack of In Vitro Testing: The description of performance studies includes biocompatibility tests (which can be in vitro, but are not the primary function of an IVD), sterilization validation, and mechanical tests. The clinical data is based on real-world patient outcomes. There is no mention of testing biological samples (blood, urine, tissue, etc.) outside of the body for diagnostic purposes.
- Anatomical Site: The device is used within the patient's jaw.
- Input Imaging Modality: Panoramic radiographs and CT are used for planning and assessment, not for analyzing biological samples.
IVD devices are designed to examine specimens derived from the human body (like blood, urine, or tissue) in vitro (outside the body) to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
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)
NHA
Device Description
Noris Medical Multi Unit and Vari Connect abutments, including 52° and 60° 2mm height prosthetic systems, and additional heights for 17°, 30°, and 45° Multi Unit and Vari Connect abutments, are subject of this current submission as part of the Dental Implants System. Vari Connect Extenders are also included, which can be added to the Vari Connect 2mm height to obtain final heights of 4, 5, 6, 7, 8 mm. The system also includes abutment fixation screws. Noris Medical Multi Unit and Vari Connect 45°, 52°, 60° abutments are intended to be used only with Noris Medical Zygomatic Dental implant (K151909). Noris Medical Multi Unit and Vari Connect 17°, 30° abutments are intended to be used only with Noris Medical Dental implants System (K140440).
The Multi-Unit system provides a solution for screw-retained prostheses, including for complicated-to-restore implants such as multiple tilted implants, and offers a full range of sizes for both upper and lower jaws. The Vari-Connect system is a complete solution for removable prostheses on tilted implants, providing equipment for both ball and flat attachments.
The implants and prosthetic components are manufactured from Titanium alloy complying with standard ASTM F 136. Abutments are anodized gold.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
either jaw (for Noris Medical Dental Implants System); upper jaw arch (for Noris Medical Zygomatic Dental Implant System)
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 Tests:
- Biocompatibility tests: Conducted in compliance with AAMI ANSI ISO 10993-5: 2009 (R) 2014 - Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity.
- Sterilization validation: Conducted according to ISO 17665-1, ISO 17665-2, and ANSI/AAMI ST79.
- Mechanical tests: Comparative fatigue testing was performed on both zygomatic predicate systems (Nobel Biocare Multi Unit 60° abutment connected to Zygomatic implant 50 mm-NobelZygoma 0°) and the subject devices (Noris Medical Multi Unit and Vari Connect 52°,60° abutments and Noris Medical Multi Unit/Variconnect 17°,30°), following a modified ISO 14801 approach using worst-case constructs. The subject device dynamic fatigue test shows equivalent performance compared to the predicate device.
Clinical Data:
- Real-world evidence from literature (Ref. 1): A retrospective study including 44 completely edentulous maxillary rehabilitations (77 Multi unit abutments) using NobelZygoma 0 implants with TiUnite surface. Abutments were 45° and 60° Multi-unit abutments External Hex RP6 mm of height. Primary outcome measures evaluated at implant surgery and 2 years post-surgery included prosthetic success, abutment success, abutment complications, modified plaque index (mPLI), modified bleeding index (mBI), mucosal seal efficacy evaluation (MSEE) >4 mm, and Zygomatic implants classification level (ZICL). Cumulative success rate at 2-years was 95.3% (patient unit) and 95.9% (implant/abutment unit). One patient lost one zygomatic implant; two 60-degree angulated abutments needed replacement in one patient due to aesthetic complaint.
- Noris Medical retrospective study: Included 33 patients (19 females, 14 males; average age 61) with 88 Multi Unit abutments. Implants were placed from 2013 to 2020. Panoramic radiographs and CT were taken pre-op and immediately after implantation, and after at least 6 months follow up. The study showed success relative to stability and no micro movements, no bleeding or soft tissue downgrowth, and no pain. Noris Medical Zygomatic implant/MU abutment survival was 100% (No failures). 14 clinical cases of Noris Medical Zygomatic implants system from 10 patients demonstrated the performance and local effects of implantation for the 60° Multi Unit abutment. Of the 33 patients, 10 used the 60° abutment.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
For Nobel Biocare Multi Unit (Ref. 1):
- Cumulative success rate at 2-years: 95.3% (patient unit) and 95.9% (implant/abutment unit).
- Cumulative Proportion Success at 7 months: 0.977.
- Survival Rate % (Placement—1 year): 98.7%
- Survival Rate % (1 year—2 years): 100%
- Survival Rate % (2 years—3 years): 100%
- Cumulative Survival Rate % (Placement—1 year, 1 year—2 years, 2 years—3 years): 98.7%
- Survival Rate of the 60° Zygomatic implant/abutment system: 93.5% (within 24 months Follow up).
For Noris Medical Multi Unit:
- Survival: 100% (No failures) based on stability, no micro movements, no bleeding or soft tissue downgrowth, and no pain observed.
- Survival Rate of the 60° Zygomatic implant/abutment system: 100% (within 6 to 48 months Follow up).
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.
K151909 - Noris Medical Ltd
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K140440 - Noris Medical Ltd, K161598-Nobel Biocare A B
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
§ 872.3630 Endosseous dental implant abutment.
(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). 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.)
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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Noris Medical Ltd Simha Sibony QA/RA 8 Hataasia Nesher, 3688808 ISRAEL
Re: K210356
Trade/Device Name: Noris Medical Dental Implants System Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: January 2, 2022 Received: January 5, 2022
Dear Simha 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. 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 located 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
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 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Andrew I. Steen Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
510(k) Number (if known) K210356
Device Name
Noris Medical Dental Implants 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) | |
|---|---|
| ------------------------------------------------- | -- |
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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Image /page/3/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.
K210356
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: | February 4, 2022 |
|---|---|
| Trade/Device Name: | Noris Medical Dental Implants System |
| Common Name: | Endosseous Dental Implant Abutment |
| Classification Name: | Abutment, Implant, Dental, Endosseous |
| Class: | II |
| Product Code: | NHA |
| CFR section: | 21 CFR§872.3630 |
| Device panel: | Dental Device Panel |
| Legally Marketed | |
| Primary Predicate | |
| Device: | K151909 - Noris Medical Ltd |
| Legally Marketed | |
| Reference Devices: | K140440 - Noris Medical Ltd |
| K161598-Nobel Biocare A B | |
| Submitter: | Noris Medical Ltd. 8 Hataasia street, Nesher 3688808, Israel |
| Contact 1: | Ms. Simha Sibony- Regulatory Affairs Consultant – GMRE |
| Ltd | |
| RA/QA Consultant | |
| M: +972 52-654-6625 | |
| T: +972 (73) 796-4477 | |
| F: +972 (4) 695-0991 | |
| E:simhasibony@gmail.com | |
| Contact 2: | Mr. Udi Dailes - VP Executive |
| Noris Medical Ltd | |
| 8 Hataasia St. Nesher 3688808 | |
| ISRAEL | |
| T: +972(54)2626719 | |
| F: +972(4)695-0991 | |
| E: udid@norismedical.com |
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Image /page/4/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 gray. Below "NORIS Medical" is the phrase "Dental Implant Solutions" also in gray. The logo is simple and modern, and the use of red and gray gives it a professional look.
2. DEVICE DESCRIPTION
2.1 NORIS MEDICAL MULTI UNIT AND VARI CONNECT ABUTMENTS
Background:
Multi Unit, Vari Connect 52° and 60° 2mm height prosthetic system are subject of this current submission as a part of the Dental Implants System (K151909).
Multi Unit 17°, 30°, (K140440) with additional 4, 5 mm gingival height are subject of this current submission.
Vari Connect 17°, 30° (K140440) with additional 4, 5, 6 mm gingival heights are subject to this current submission.
Multi Unit 45°(K151909) with additional 4, 5 mm gingival height are subject of this current submission. Vari Connect 45°(K151909) with additional 4,5,6 mm gingival heights are subject to
Illustration of Gingival Height:
this current submission.
Multi Unit
Vari Connect
Image /page/4/Picture/11 description: The image shows a cross-sectional view of a threaded fitting. The fitting has an angled body with a threaded internal bore. The outer diameter of the fitting is labeled as 3.75, and the inner diameter is labeled as 2.42. The height of the fitting is also labeled.
Image /page/4/Picture/12 description: This image is a technical drawing of a part, showing its dimensions and features. The drawing includes measurements such as a diameter of 4.9, a height labeled as 'Height', and a platform with a diameter of 3.75. Additionally, the drawing specifies a thread size of M3 and a dimension of 2.1 on one side. The drawing provides a detailed view of the part's geometry and dimensions.
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Image /page/5/Picture/0 description: The image shows the logo for Noris Medical Dental Implant Solutions. The logo consists of a red abstract shape on the left, followed by the text "NORIS Medical" in gray. Below the text is the phrase "Dental Implant Solutions" in a smaller, lighter gray font.
Vari Connect Extender
| Vari-Connect Platform Extender | ||||
|---|---|---|---|---|
| Platform Extender | ||||
| Height (mm) | ||||
| 2 | 3 | 4 | 5 | 6 |
| Image: Platform Extender 2mm | Image: Platform Extender 3mm | Image: Platform Extender 4mm | Image: Platform Extender 5mm | Image: Platform Extender 6mm |
| NM-T7282 | NM-T7283 | NM-T7284 | NM-T7285 | NM-T7286 |
| Image: Platform Extender Diagram | ||||
| Platform | ||||
| Extender Height | Extender | |||
| Tightening | ||||
| Torque | ||||
| 30-35Ncm | ||||
| Vari-Connect | ||||
| Platform | ||||
| Height | ||||
| Total Platform | ||||
| Height |
By adding the extenders to Vari Connect 2mm height, the final heights of 4, 5,6,7,8 mm will be obtained.
The system also includes abutment fixation screws.
Noris Medical Multi Unit and Vari Connect 45°, 52°, 60° abutments are intended to be used only with Noris Medical Zygomatic Dental implant (K151909).
Noris Medical Multi Unit and Vari Connect 17°, 30° abutments are intended to be used only with Noris Medical Dental implants System(K140440).
2.2.1 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.
2.2.2 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
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Image /page/6/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 gray. Below the text, it says "Dental Implant Solutions" also in gray.
on ball attachments and flat attachments, covering a wide range of possible situations. Complementary products: Vari Connect extenders are fixed to the Vari Connect abutment by the extender's thread.
| ANGLED MULTI-UNIT | ANGLED VARI-CONNECT | ||||||
|---|---|---|---|---|---|---|---|
| Angled Multi-Units | Angle Vari-Connect | ||||||
| Multi-Unit Platform Height (mm) | Vari-Connect Platform Height (mm) | ||||||
| Angle° | 2 | 3 | 4 | 5 | Angle° | 2 | 3 |
| 17° | NM-A7112 | NM-A7113 | NM-A7114 | NM-A7115 | 17° | NM-A7212 | NM-A7213 |
| 30° | NM-A7133 | NM-A7134 | NM-A7135 | NM-A7136 | 30° | NM-A7233 | NM-A7234 |
| 45° | NM-A7144 | NM-A7145 | NM-A7146 | NM-A7147 | 45° | NM-A7244 | |
| 52° | NM-A7152 | Included with all multi-unit bases |
Abutment Cary-on handle
NM-S7101 NM-X7101 | | | 52° | NM-A7252 | |
| 60° | NM-A7160 | | | | 60° | NM-A7260 | |
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Image /page/7/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" is the text "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.
3. 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. Abutments are anodized gold, the same as the reference device K140440.
4. 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 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.
5. SUBSTANTIAL EQUIVALENCE CLAIMED TO PREDICATE DEVICES
Identification of the Legally Marketed Predicate Devices Used to Claim Substantial Equivalence:
Noris Medical Multi Unit and Vari Connect 52°,60° abutments subject to this submission are substantially equivalent to Primary predicate – Noris Medical Dental Implant System (K151909) in terms of intended use, design, and materials used.
Reference Device - Nobel Biocare K161598 Multi Unit 60° abutment connected to Zygomatic implant 50 mm-NobelZygoma 0° is equivalent to current submission in terms of performance testing. Reference Device Noris Medical Dental Implant System (K140440) is equivalent to current submission in terms of similar 3.75 mm Platform and Internal Hex connection for all abutments components connected to the same Noris Medical Dental implants system.
With regards to the intended use, material, design, characteristics and dimensions, the equivalence was determined through the points in following pages:
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Image /page/8/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.
Table 1: Comparison of subject and predicate abutments characteristics (K151909)
| | Nobel Biocare
Multi Unit 60°
abutment
Reference
Device | Noris Medical
Zygomatic Dental
Implant System-
Primary Predicate
Multi Unit/Variconnect | Noris Medical
Dental Implant
System-
Current
Submission
Multi
Unit/Variconnect
Connected to Noris
Zygomatic Dental
Implant system
K151909 only | Equivalence
Discussion |
|-----------------------|--------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|
| 510k | K161598 | K151909 | Current Submission | - |
| Indication for
use | [3] | [2] | [4] | Identical
Same indication for
use for subject and
primary predicate |
| Patient
Population | Edentulous or
partially
edentulous
individuals | Edentulous or partially
edentulous individuals | Edentulous or
partially edentulous
individuals | Identical |
| Material
abutments | Titanium alloy | Titanium alloy | Titanium alloy | Identical
Subject and
predicate devices
have the same
material of
construction. |
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Image /page/9/Picture/0 description: The image shows the logo for NORIS Medical, a company that provides dental implant solutions. The logo consists of a red abstract shape on the left and the words "NORIS Medical" in gray on the right. Below the company name, the words "Dental Implant Solutions" are written in a smaller, lighter gray font. The logo is simple, modern, and professional.
| 45,60 | 45 | 45,52,60 | SE | |
|---|---|---|---|---|
| Abutments° | the angulation is | |||
| equivalent to the | ||||
| reference device | ||||
| Abutment | ||||
| Gingival | ||||
| Height-mm | 45°: 6mm, | |||
| 8mm, 10mm | ||||
| 60°: 6mm,8mm | 2 mm | Multi Unit 45°: | ||
| 3,4,5 mm | ||||
| Variconnect 45° | ||||
| extender: | ||||
| 3,4,5,6 mm | ||||
| 52°,60°: 2 mm | SE: The subject | |||
| device is equivalent | ||||
| to reference device. | ||||
| Dynamic fatigue | ||||
| test of the subject | ||||
| device shows | ||||
| equivalent | ||||
| performance in | ||||
| comparison to | ||||
| predicate device | ||||
| See Section 6.3 | ||||
| Screw | ||||
| material | Titanium alloy | Titanium alloy | Titanium alloy | Identical |
| Compatible | ||||
| implant | ||||
| abutment | External Hex | |||
| Regular | ||||
| Platform (RP) | Internal Hex | |||
| 3.75mm platform | Internal Hex | |||
| 3.75mm platform | Identical to | |||
| predicate device | ||||
| Sterility | Supplied sterile | |||
| Single use | Supplied non-sterile. | |||
| Single use | ||||
| Steam sterilized before | ||||
| use | Supplied non-sterile. | |||
| Single use | ||||
| Steam sterilized | ||||
| before use | Identical to primary | |||
| predicate device |
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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 and the words "NORIS Medical" in gray on the right. Below the company name, the words "Dental Implant Solutions" are written in a smaller font, also in gray.
Table 2: Comparison of subject and predicate abutments characteristics (K140440)
| | Noris Medical
Dental Implants
system- Reference
Device | Noris Medical
Dental Implants System-
Current Submission
Multi Unit/Variconnect
Connected to Noris Medical
Dental implants K140440
only | Equivalence
Discussion:
Identical/SE |
|------------------------------------|-----------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510k | K140440 | Current Submission | - |
| Intended use | [1] | [4] | Identical
Same indication for
use for subject and
primary predicate |
| Patient
Population | Edentulous or partially
edentulous individuals | Edentulous or partially
edentulous individuals | Identical |
| Material
abutments | Titanium alloy | Titanium alloy | Identical
Subject and predicate
devices have the
same material of
construction |
| Abutments° | 0,15,17,25,30 | Multi Unit/Variconnect 17,30 | Identical
the angulation is
equivalent to the
primary predicate
device |
| Abutment
Gingival Height-
mm | Multi Unit 17,30°:
2,3 mm
Variconnect 17,30°:
2mm | Multi Unit 17,30°:
4,5 mm
Variconnect 17°,30° extender:
2,3,4,5,6 mm | SE : The subject
device has additional
gingival Height.
Worst cases
calculations for Multi
unit with higher
angulations show
equivalent
performance in
comparison to their
primary predicate
device
See Section 6.3 |
| Screw material | Titanium alloy | Titanium alloy | Identical |
| Compatible
implant
abutment | Internal Hex
3.75mm platform | Internal Hex
3.75mm platform | Identical
Subject and primary
predicate devices are
compatible with the
same devices. |
| Sterility | Supplied non-sterile.
Single use
Steam sterilized before
use | Supplied non-sterile.
Single use
Steam sterilized before use | Identical to primary
predicate device |
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Image /page/11/Picture/0 description: The image is 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" also in gray.
[1] 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.
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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 gray. Below the company name, the text "Dental Implant Solutions" is written in a smaller font, also in gray.
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 singletooth restorations. Multiple-unit restorations should be splinted together and may be used immediately when clinically appropriate.
[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. 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 with partially or fully edentulous maxillae.
[3] Nobel Zygoma implants are endosseous implants intended to be surgically placed in the bone of the upper iaw arch to provide support for the prosthetic devices, such artificial teeth, in order to restore patient esthetics and chewing function. The NobelZygoma Implants are appropriate for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
[4] 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,
Evidence of equivalence has been demonstrated through:
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The Noris Medical Dental Implants System intended use and indications for use are similar to previously cleared FDA cleared predicate and reference devices.
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The technical characteristics of the Noris Medical Dental implants System are similar to those of the predicate and reference devices.
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Clinical and non-clinical performance testing results of the Noris Medical Dental implants System are similar to those of the predicate and reference devices.
Therefore, the Noris Medical Dental Implants System is substantially equivalent to the predicate device in terms of intended use, materials used, and technological characteristic
6. NON-CLINICAL TEST
6.1 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
6.2 Sterilization
Sterilization validation for subject devices was conducted according to ISO 17665-1, ISO 17665-2, and ANSI/AAMI ST79.
6.3 Mechanical tests
Comparative fatigue testing was performed on both zygomatic predicate systems as well as the subject devices, following a modified ISO 14801 approach to reflect the extra-maxillary surgical techniques of the subject and predicate systems, utilizing worst-case constructs for each system
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Image /page/13/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 gray. Below the text, it says "Dental Implant Solutions" in a smaller, lighter gray font.
7. CLINICAL DATA
Real-world evidence of Nobel Biocare Zygomatic implant system cases were provided from the literature to address the clinical concerns regarding the worst case angulation 60° Multi Unit abutment subject to this submission to legally marketed Nobel Biocare Multi Unit 60°
Nobel Biocare Multi Unit (predicate device) presented in Ref. 1 below is provided as real world evidence data: A retrospective study including a total of 44 completely edentulous maxillary rehabilitations (77 Multi unit abutments) were performed.
The zygomatic implants used in this study were NobelZygoma 0 with a TiUnite surface (Nobel Biocare AB, Göteborg, Sweden), and typically emerged between the first premolar and the first molar on the residual crest of the ridge, near its center).The study abutments were 45 and 60 Multi-unit abutments External Hex RP6 mm of height. The surgical protocol followed previous indications for zygomatic implants inserted through the extramaxillary surgical technique.
This implant is the predicate device presented in this current submission and the extramaxillary surgical technique is the same as Noris Medical surgical technique for Zygomatic implants.
Outcome Measures
Outcome measures were evaluated at implant surgery and at 2 years post-surgery.
The primary outcome measures were prosthetic success, abutment success, abutment success and complications. modified plaque index (mPLI), modified bleeding index (mBI), mucosal seal efficacy evaluation (MSEE) >4 mm, and Zygomatic implants classification level (ZICL). Prosthetic success was judged in terms of function, being considered a failure if need to be replaced by a new prosthesis. Two patients (4.5%) were lost to follow-up. No prosthesis was lost; one patient lost one zygomatic implant; two angulated abutments of 60 degrees needed to be replaced in one patient due to an aesthetic complaint; rendering a cumulative success rate at 2-years of 95.3% and 95.9% using patient and implant/abutment as unit of analysis, respectively.
Table 3: Summary of clinical cases of Nobel Biocare Zygomatic/ Multi Unit system
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Image /page/14/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 gray. Below the text "NORIS Medical" is the text "Dental Implant Solutions" in a smaller, lighter gray font. The logo is clean and modern, and the use of red and gray gives it a professional look.
| (a) | Cumulative Proportion Success at the Time | |||||
|---|---|---|---|---|---|---|
| Time (Months) | Status | |||||
| (0 = Success; | ||||||
| 1 = Failure *) | Estimate | Std. Error | N of Cumulative | |||
| Events | N of Patients at | |||||
| Risk | ||||||
| 0 | 0 | 0 | 44 | |||
| 7 | 1 | 0.977 | 0.022 | 1 | 43 | |
| 9 | 0 | 1 | 42 | |||
| 10 | 0 | 1 | 41 | |||
| 12 | 0 | 1 | 41 | |||
| 13 | 0 | 1 | 40 | |||
| 24 | 0 | 1 | 40 | |||
| (b) | ||||||
| Duration | Total | Failed | Lost to Follow-Up | Censored | Survival Rate % | Cumulative |
| Survival Rate % | ||||||
| Placement—1 year | 77 | 1 | 1 | 5 | 98.7% | 98.7% |
| 1 year—2 years | 70 | 0 | 2 | 2 | 100% | 98.7% |
| 2 years—3 years | 52 | 0 | 0 | 25 | 100% | 98.7% |
- Failure was defined as the first implant to fail in one patient.
Citation:
Ref. 1 : Angulated Abutments for Full-Arch Rehabilitation of Extremely Atrophic Maxillae : Short-Term Outcome of a Retrospective Cohort - Armando L, Miguel de Araújo Nobre, Ana Ferro, Carlos Moura Guede, Ricardo Almeida and Mariana Nunes , J. Clin. Med. 2021, 10, 3600
Noris Medical Multi Unit (subject device) clinical cases report was submitted.
This Noris Medical retrospective study included 33 patients (19 females and 14 males) with 88 Multi Unit abutment. The patients were on average 61 (36–86) years old. Patients required dental extraction and immediate replacement.
The implants were placed during the years 2013 to 2020. Patients were treated with Multi Unit abutments.
Panoramic radiographs and CT were taken Pre-op and Panoramic radiographs immediately after implantation and after at least 6 months follow up.
In this report 33 patients (88 Multi unit abutments) showed success relative to stability and no micro movements, no bleeding or soft tissue downgrowth, no pain was observed. Table 4 below provides a summary of the cases demonstrating that Noris Medical Zygomatic implant/MU abutment survival was 100 %( No failures). To evaluate the performance and local effects of implantation, 10 patients representing 14 clinical cases of Noris Medical Zygomatic implants system were provided to address concerns regarding the worst case angulation 60° Multi Unit abutment subject to this submission. Of the 33 patients noted, 10 used the 60° abutment.
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r
Table 4: Summary of clinical cases of Noris Medical Zygomatic/Multi Unit System
| Case
no. | Gender | Age
[yea
rs] | Position | Catalog
number | Follow-
up period
[month] | Angle
of
Multi
Unit | Status
(0=Suc
cess;
1=Failu
re) |
|-------------|--------|--------------------|--------------|-------------------|---------------------------------|------------------------------|---------------------------------------------|
| 1 | F | 79 | 4, 2, 13 | NM-A7144 | 8 | 45° | 0 |
| 2 | F | 53 | 4, 2, 13, 15 | NM-A7144 | 9 | 45° | 0 |
| 3 | F | 52 | 2, 13, 15 | NM-A7144 | 11 | 45° | 0 |
| 4 | F | 65 | 4, 2, 13, 15 | NM-A7144 | 13 | 45° | 0 |
| 5 | M | 52 | 2, 13, 15 | NM-A7144 | 8 | 45° | 0 |
| 6 | F | 56 | 4, 2, 13, 15 | NM-A7144 | 17 | 45° | 0 |
| 7 | F | 64 | 4, 2, 13, 15 | NM-A7144 | 7 | 45° | 0 |
| 8 | M | 71 | 4, 13 | NM-A7144 | 11 | 45° | 0 |
| 9 | M | 58 | 4, 2, 13, 15 | NM-A7144 | 10 | 45° | 0 |
| 10 | M | 51 | 2, 13, 15 | NM-A7144 | 14 | 45° | 0 |
| 11 | M | 68 | 4, 2, 15 | NM-A7144 | 13 | 45° | 0 |
| 12 | F | 55 | 2, 13, 15 | NM-A7144 | 8 | 45° | 0 |
| 13 | M | 64 | 4, 2, 13, 15 | NM-A7144 | 11 | 45° | 0 |
| 14 | M | 80 | 4, 2, 13, 15 | NM-A7144 | 10 | 45° | 0 |
| 15 | F | 60 | 4, 2, 13, 15 | NM-A7144 | 10 | 45° | 0 |
| 16 | F | 36 | 2, 13 | NM-A7144 | 6 | 45° | 0 |
| 17 | F | 52 | 2, 15 | NM-A7144 | 7 | 45° | 0 |
| 18 | F | 43 | 15 | NM-A7144 | 7 | 45° | 0 |
| 19 | M | 43 | 2 | NM-A7144 | 7 | 45° | 0 |
| 20 | F | 58 | 15 | NM-A7144 | 6 | 45° | 0 |
| 21 | M | 45 | 15 | NM-A7144 | 8 | 45° | 0 |
| 22 | M | 66 | 4 | NM-A7144 | 11 | 45° | 0 |
| 23 | F | 67 | 6 | NM-A7152 | 13 | 52° | 0 |
| 24 | F | 61 | 3, 14 | NM-A7145 | 47 | 45° | 0 |
| 24 | F | 61 | 6 | NM-A7152 | 47 | 52° | 0 |
| 24 | F | 61 | 11 | NM-A7160 | 47 | 60° | 0 |
| 25 | F | 86 | 4, 2,13,15 | NM-A7145 | 11 | 45° | 0 |
| 25 | F | 86 | 7 | NM-A7160 | 11 | 60° | 0 |
| 26 | M | 43 | 3, 14 | NM-A7152 | 48 | 52° | 0 |
| 26 | M | 43 | 6, 11 | NM-A7160 | 48 | 60° | 0 |
| 27 | M | 72 | 3 | NM-A7160 | 13 | 60° | 0 |
| 28 | F | 68 | 6, 11 | NM-A7160 | 12 | 60° | 0 |
| 29 | F | 67 | 4 | NM-A7160 | 13 | 60° | 0 |
| 30 | M | 78 | 6, 11 | NM-A7160 | 15 | 60° | 0 |
| 31 | M | 81 | 6, 4 | NM-A7160 | 12 | 60° | 0 |
| 32 | F | 81 | 11 | NM-A7160 | 14 | 60° | 0 |
| 33 | F | 79 | 6 | NM-A7160 | 14 | 60° | 0 |
| 33 | F | 79 | 4, 11,14 | NM-A7144 | 14 | 45° | 0 |
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Image /page/16/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 that, the words "Dental Implant Solutions" are also written in gray. The logo is simple and modern, and it conveys a sense of professionalism and expertise.
Conclusion:
The Nobel Biocare MU cases presented in this report (real world evidence data -see ref. 1 above) demonstrated substantially equivalent success of the predicate Device All the Noris Medical MU cases presented in the submitted cases report demonstrate substantial equivalence results compared to Nobel Biocare predicate device in term of status of success.
Table 5 below details the Number of different Multi Unit angles that is included in the Noris Medical cases report and in the Nobel Biocare real world evidence clinical data.
Table 5: No. of MU abutment Cases- Noris Medical vs Nobel Biocare
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Image /page/17/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 the words "NORIS Medical" is the phrase "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 area of expertise.
| Multi-unit Angle
(degrees) | No. of abutments used –
Noris Medical | No. of abutments
used –Nobel Biocare |
|-------------------------------|------------------------------------------|-----------------------------------------|
| 45 | 70 | 31 |
| 52 | 4 | - |
| 60 | 14 | 46 |
| Total: | 88 | 77 |
No adverse events norinflammation were reported and the follow up showed 100% success of the Noris Medical MU abutment by attaining the end point of continuous stability of implant with no inflammation after at least 6 months.
Survival Rate of the 60° Zygomatic implant/abutment system Noris Medical was 100% vs Nobel Biocare was 93.5% within 6 months to 48 months Follow up and 24 months Follow up respectively.
8. CONCLUSION
The data presented in this submission demonstrates that the subject devices are substantially equivalent with respect to performance and intended use. The proposed devices perform as well as the legally marketed primary and reference devices. The subject device, the primary predicate device, and the reference device have the same intended use, have similar technological characteristics. The subject device and the primary predicate, are made of identical materials, are packaged in the same materials, and are sterilized using the same methods. The data included in this submission demonstrate substantial equivalence to the predicate devices listed above.
Furthermore, the subject devices do not pose any new or increased risks as compared to the legally marketed predicate devices listed above.