Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a physical dental implant system and its clinical performance, with no mention of AI or ML technology in its design, function, or analysis of data.

Therapeutic

Yes
Dental implants are considered therapeutic devices because their intended use is to restore a patient's chewing function and support prosthetic devices, which directly addresses a medical condition (missing teeth) to improve health and well-being.

Diagnostic

No

This device is described as a dental implant system intended to replace missing teeth, not to diagnose medical conditions or diseases.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a physical dental implant made of titanium alloy, which is a hardware component.

IVD (In Vitro Diagnostic)

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 tooth/teeth in either jaw for supporting prosthetic devices that may aid in restoring the patient's chewing function." This describes a surgical implant for structural support and functional restoration within the body.
Device Description: The device is a "tapered internal hex 2.1. implants" made of titanium alloy. This is a physical implant designed to be surgically placed.
Lack of Diagnostic Purpose: The description and intended use do not mention any function related to diagnosing a disease, condition, or state of health. IVDs are used to examine specimens (like blood, urine, or tissue) from the human body to provide information for diagnosis, monitoring, or screening.

This device is a medical device, specifically a dental implant, but it does not fit the definition of an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

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.

Product codes (comma separated list FDA assigned to the subject device)

DZE

Device Description

Noris Medical Dental Implants are tapered internal hex 2.1. implants, designed to enable easy insertion while supporting excellent initial stability. The variable thread design enables self-tapping, thus providing solutions for a variety of bone conditions. Noris Medical multi-design features offer a solution for immediate placement and immediate loading. The implantation procedure can be accomplished in a one-stage or two-stage surgical operation. Packaging has been designed for quick identification and easy opening.

The Noris Medical Cortical Implant is part of the Noris Medical dental Implants system identical platform. Cortical implants are able to undergo immediate loading when good primary stability is achieved and with appropriate occlusal loading. The Cortical system can be used in extraction sites for immediate implantation. Cortical implant is available in different sizes to suit relevant implantation site.

Cortical - NM-MXXXX

Diameter 4.0 mm, Length 11.5, 13, 16, 18, 20 mm
Diameter 5.0 mm, Length 11.5, 13, 16 mm
Diameter 6.0 mm, Length 11.5, 13,16 mm

Made of titanium alloy Ti 6Al 4V ELI.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

either jaw, maxillary or mandibular molar areas, upper and lower jaws

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Clinical Test
Summary: OUS retrospective clinical study in which 40 Noris cortical implants were placed in 19 patients, 9 Male and 10 Female, ages 49-82 (average age 69) during years 2018-2019 in Israeli private clinic. The sample population was statistically derived as n=38. For inclusion in study, all patients required extraction and immediate placement of subject implant with immediate loading. Panoramic radiographs and CT were taken pre-op, along with panoramic radiographs taken immediately after implantation and after at least 6 months follow up. Radiographs provided baseline crestal bone height data for each patient case, with crestal bone level being measured from the base of the smooth, unmachined basket portion of implant body as the subject device is a tissue level device. Specific tooth crestal bone height measurements are provided for selected teeth from each panoramic film, serving as key teeth measured at baseline, 12 months and as late as 33 months. At subsequent patient evaluations, bone loss is calculated based on the total cortical dental implant length minus the 4 mm length of the smooth surface basket.

Acceptance Criteria: Pass Criteria for 1 Year ≤1mm; for 2 Years

Regulation Number and Section

§ 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.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

Noris Medical Ltd Simha Sibony VP Regulatory Science 8 Hataasia Nesher, 3688808 ISRAEL

Re: K210852

Trade/Device Name: Noris Medical Dental Implants System - Cortical Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE Dated: May 18, 2022 Received: May 25, 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.

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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 Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K210852

Device Name

Noris Medical Dental Implants System -Cortical

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.

Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image shows the logo for Noris Medical. The logo consists of a red abstract shape on the left and the words "NORIS Medical" in gray on the right. Below the words "NORIS Medical" is the phrase "Dental Implant Solutions" in a smaller, lighter gray font. The logo is simple and modern, and it conveys a sense of professionalism and expertise.

510(k) Summary- K210852

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 Implant System- Cortical

1. GENERAL INFORMATION

Date Prepared:	June 24, 2022
Common Name:	Noris Medical Dental Implants System - Cortical
Classification
Name:	Endosseous dental implant
Class:	Implant, Endosseous, Root-Form
Product Code:	II
CFR section:	DZE
Device panel:	21 CFR 872.3640
Legally Marketed
Predicate Device:	Dental
Legally Marketed
Reference Devices:	K140440 - Noris Medical Ltd
Submitter:	K140091 MegaGen Implant Co., Ltd., K200586
Straumann USA, LLC; K151909-Noris Medical Ltd
Contact 1:	Noris Medical Ltd. 8 Hataasia street, Nesher 3688808,
Israel
Contact 2:	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
	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 shows the Noris Medical logo, which includes a red geometric shape on the left and the text "NORIS Medical" in gray on the right. Below the company name, it says "Dental Implant Solutions" in a smaller font. The text "2. DEVICE DESCRIPTION" is at the bottom of the image in bold.

BACKGROUND -Noris Medical Dental Implants are tapered internal hex 2.1. implants, designed to enable easy insertion while supporting excellent initial stability. The variable thread design enables self-tapping, thus providing solutions for a variety of bone conditions. Noris Medical multi-design features offer a solution for immediate placement and immediate loading. The implantation procedure can be accomplished in a one-stage or two-stage surgical operation. Packaging has been designed for quick identification and easy opening. (Noris Medical cleared K140440).

The scope of this submission is Noris Medical Cortical Implant as part of the Noris Medical dental Implants system identical platform.

NORIS MEDICAL CORTICAL IMPLANTS 2.2.

Cortical implants are able to undergo immediate loading when good primary stability is achieved and with appropriate occlusal loading. The Cortical system can be used in extraction sites for immediate implantation. Cortical implant is available in different sizes to suit relevant implantation site.

Image /page/4/Picture/5 description: The image shows a dental implant. The implant is made of metal and has a screw-like shape. The top of the implant is smooth and rounded, while the bottom is sharp and pointed. The implant is designed to be inserted into the jawbone to support a false tooth.

Cortical - NM-MXXXX
Diameter 4.0 mm	Length 11.5, 13, 16, 18, 20 mm
Diameter 5.0 mm	Length 11.5, 13, 16 mm
Diameter 6.0 mm	Length 11.5, 13,16 mm

Made of titanium alloy Ti 6Al 4V ELI

INDICATION FOR USE 3.

Noris Medical Dental Implants System is intended to replace missing tooth/teeth in either jaw for supporting prosthetic devices that may aid in restoring the patient's chewing function. The procedure can be accomplished in a one-stage or two-stage surgical operation. All implants are appropriate for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

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Image /page/5/Picture/0 description: The image contains the logo for Noris Medical. The logo consists of a red abstract shape on the left, followed by the text "NORIS Medical" in gray. Below the text, it says "Dental Implant Solutions" also in gray.

4. SUBSTANTIAL EQUIVALENCE CLAIMED TO PREDICATE DEVICES

Identification of the Legally Marketed Predicate Devices Used to Claim Substantial Equivalence:

Predicate device: K140440 – Noris Medical Ltd – TUFF implant with regards to intended use, material, platform internal Hex design, packaging and sterilization.

Reference predicate device: K151909-Noris Medical Ltd with regards to RBM surface treatment

Reference predicate device 1: K140091 MegaGen Implant Co., Ltd. with regards to threads design.

Reference predicate device 2: K200586 Straumann USA, LLC with regards to neck implant design.

5. Summary of similarities and differences (See Table 1 and Fig.1 below)

Indications for Use:

[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.

[2] The Xpeed AnyRidge Internal Implant System is intended to be surgically placed in the maxillary or mandibular molar areas for the purpose providing prosthetic support for dental restorations (Crown, bridges, and overdentures) in partially or fully edentulous individuals. It is used to restore a patient's chewing function. Smaller implants (less than Ø6.0 mm) are dedicated for immediate loading when good primary stability is achieved and with appropriate occlusal loading. Larger implants are dedicated for the molar region and are indicated for delayed loading.

[3] Straumann TLX Implants are suitable for endosteal implantation in the upper and lower jaws and for the functional and esthetic oral rehabilitation of edentulous and partially edentulous patients. TLX Implants can be placed with immediate function on single-tooth multi-unit restorations when good primary stability is achieved and with appropriate occlusal loading to restore chewing function. The prosthetic restorations are connected to the implants through the corresponding abutment component.

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Image /page/6/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 written in a smaller, lighter gray font. The logo appears to be for a company that provides dental implant solutions.

5.1 Similarities

The subject device has the followings same/equivalent characteristic for the compared to the predicate device (Noris TUFF K140440):

Indication for use, Internal Connection, Single Use, Material, Sterilization and Shelf Life.

The subject device has the followings same/equivalent characteristic for the compared to the reference 1 (Megagen AnyRidge K140091):

Indication for use, Design of threads, Internal Connection, Single Use, Sterilization.

The subject device has the followings same/equivalent characteristic for the compared to the reference 2 (Straumann TLX K200586):

Indication for use, Design shape (gingival section), Type (Tissue Level), Single Use, Sterilization.

The diameter and length of subject device lies in the range of all predicate and reference devices.

5.2 Differences

The subject device has the different characteristic for the followings compared to the predicate and reference devices:

1) Gingival (Cuff)

The subject device is different from predicate and Ref 1 devices since the subject device is Tissue level design and the others are Bone level design implants.

Gingival (Cuff) Height (compared only to Ref 2)

The subject device has cuff height 4mm with consideration for soft tissue level similar to the Ref 2 device (3.3 mm).

The size of cuff height is a very minor parameter and is not considered affecting substantial equivalence, the cuff height provides good gingival adaptation and the variety of the size enables to operate with a more precise treatment in order to meet each patient's gingival condition.

2) Fixture Diameter and Thread Depth

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Image /page/7/Picture/0 description: The image shows the logo for Noris Medical, a dental implant solutions company. 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.

The subject device has major fixture diameters of 4mm, 5mm and 6mm similar to Ref. 2 device and are considered as equivalent.

The subject device has minimum thread depth slightly higher than the Ref. 1 device and are considered equivalent.

DISCUSSION OF DIFFERENCES

1. As demonstrated in SE (Substantial Equivalent) table, the range of Neck rough Endosseous and Non-Threaded Section is 0.7-3.5 vs 1.0-2.0 mm for the subject device vs the Ref 2 device respectively. This non-threaded section of the implant is not significant to the primary and long-term stability. We have provided comprehensive SE table including required characteristics such as the comparison to the depth of the thread.
  The subject device features a deeper thread of 0.4mm to 1.2mm (for diameters ranges from Ø 4 to Ø6) compared to AnyRidge Megagen (Ref 1) (for diameters of Ø3.5 to Ø8) which offers the thread depth of 0.35mm to 1 mm.
1. The clinically relevant section of the implant with respect to the bone is the length of the threaded and non-threaded rough portion that are surface treated (L). This portion is to be osseointegrated. According to this length, Noris' (subject device) and Ref 1 &2 lengths are equivalent, please see on SE table the parameter L (Implant Length) . Although Noris' threaded portion (see SE table parameter Fixture Length = L-
  L3) is shorter compared to Ref 2, this length is indeed clinically relevant to initial stability. However, the initial stability is mostly affected by the implants features such as the thread design and thread's depth (e.g. implants dimensions) are also contributing to the stability.
1. Fixture diameter of subject device is lower than Ref 1 This difference is related to the higher thread's depth of subject device. The subject device has major fixture diameters of 4mm, 5mm and 6mm similar to Ref.1 adevice and are considered as equivalent (see discussion below).

Summary of equivalence was determined through the points in following Table 1.

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Image /page/8/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 lighter shade of gray.

Fig. 1 – Dimensions of the implants (Subject and references):

(A) Cortical Noris –Subject device (B) AnyRidge Megagen- Ref. 1 (C) Straumann TLX –Ref.2

Image /page/8/Figure/3 description: The image shows three different types of dental implants: Cortical Noris, AnyRidge Megagen, and Straumann TLX. Each implant is labeled with its name and has several dimensions indicated by arrows and labels such as D1, D2, L1, L2, L3, L, P, and D. The diagrams illustrate the different shapes and sizes of the implants, highlighting the variations in their design and dimensions.

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Image /page/9/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 modern, suggesting a focus on medical technology and dental implants.

Table 1- Summary of Equivalence

| Feature | Subject
Device/Present
Submission | Predicate
Device | Reference Device
1 | Reference Device
2 | Equivalent
or
Identical |
|----------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K210852 | K140440 | K140091 | K200586 | - |
| Device Name | Noris Medical
Dental Implants
System -Cortical | Noris Medical
Dental Implants
System - TUFF | Xpeed AnyRidge
Internal Implant
System | Straumann TLX
Implant System-
TLX S | - |
| Sponsor/
Manufacturer | Noris Medical Ltd | Noris Medical Ltd | MegaGen Implant
Co., Ltd | Institut Straumann
AG | - |
| Design shape | Image: Subject Device | Image: Predicate Device | Image: Reference Device 1 | Image: Reference Device 2 | Equivalent to Ref.
1+2 |
| Indication for Use | [1] | [1] | [2] | [3] | SE |
| Product Code | DZE | DZE | DZE | DZE | SE |
| Feature | Subject
Device/Present
Submission | Predicate
Device | Reference Device
1 | Reference Device
2 | Equivalent
or
Identical |
| Target Population | Edentulous or
partially
edentulous
individuals | Edentulous or
partially
edentulous
individuals | Edentulous or
partially
edentulous
individuals | Edentulous or
partially
edentulous
individuals | SE |
| Material | Titanium alloy | Titanium alloy | CP Ti Grade 4 | Titanium-13
Zirconium alloy
(Roxolid®) | Identical to predicate |
| Diameter [mm]
Widest Diameter | 4.0, 5.0, 6.0 | 3.3, 3.75, 4.2, 5, 6 | For normal ridge:
4.0, 4.4, 4.9, 5.4,
5.9

For Ø5.0: 11.5,
13.0, 16.0

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Image /page/10/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, followed by the text "NORIS Medical" in gray. Below the company name, the text "Dental Implant Solutions" is written in a smaller font size, also in gray.

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Image /page/11/Picture/0 description: The image contains the logo for NORIS Medical, a company that specializes in dental implant solutions. The logo consists of a red abstract shape on the left, followed by the company name in gray text. Below the company name, the words "Dental Implant Solutions" are written in a smaller, lighter gray font.

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Image /page/12/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.

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Image /page/13/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, followed by the text "NORIS Medical" in gray. Below the company name, the text "Dental Implant Solutions" is also written in gray.

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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 words "NORIS Medical" in gray. Below "NORIS Medical" is the text "Dental Implant Solutions" also in gray.

❖ SE- Substantially Equivalent

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Image /page/15/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 company name, the text "Dental Implant Solutions" is written in a smaller, lighter gray font.

6. PROSTHETICS COMPONENTS – Substantial Equivalence

The Prosthetics components connected to the subject device-Cortical implants are same as the prosthetic devices submitted with predicate device - K140440.

The connection platform is 3.75mm internal Hex for all the prosthetic components.

	Noris Medical
Feature
K510	K140440
Product Name	Healing cap
Intended use	Used to allow the gingiva to heal around
implants.
Material	Titanium alloy
Diameter (mm)	3.8,4.6,5.5,6.3
Height (mm)	2,3,4,5,6,7
Angle	0
Sterility	Non-sterile

Healing Caps

Straight abutment

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Image /page/16/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 size, also in gray.

Feature	Noris Medical
Product Name	Straight abutment
K510	K140440
Intended use	The straight abutment is used in the fabrication of cement-retained restorations, single crowns or bridges.
Material	Titanium alloy
Diameter (mm)	3.75, 3.8, 4.5, 5.2, 5.5, 9
Height (mm)	6, 8, 8.5, 9, 9.5, 10, 10.5, 11, 11.5, 12, 12.5, 15
Angle	0
Sterility	Non-sterile

Angular Abutments

Feature	Noris Medical
Product Name	Angular Abutments
K510	K140440
Intended use	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.
The abutments are available with angles of 15° and 25°
degrees.
Material	Titanium alloy
Diameter (mm)	4, 4.5, 5.4
Height (mm)	9, 9.5, 10.5, 11, 11.5, 12.5
Angle (°)	15, 25
Sterility	Non-sterile

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Image /page/17/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 text, it says "Dental Implant Solutions" also in gray.

Esthetic Screw Abutments

Feature	Noris Medical
K510	K140440
Product Name	Esthetic Screw Abutments
Intended use	Esthetic Screw Abutment is intended for the screw
retained rehabilitation process on single or multiple
units.
Material	Titanium alloy
Diameter (mm)	4.7
Height (mm)	0.5, 1.5 ,2.5
Angle (º)	0
Sterility	Non-sterile

Ball attachment

Feature	Noris Medical
K510	K140440
Product Name	Ball attachment
Intended use	The ball attachment superstructure is intended to secure
a removable prosthesis.
Material	Titanium alloy
Height (mm)	0.5,1,2,3,4,5,6
Angle (°)	0
Sterility	Non-sterile

Flat attachment

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Image /page/18/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.

Feature	Noris Medical
Product Name	Flat attachment
K510	K140440
Intended use	The Flat attachment superstructure is intended to
secure an overdenture
Material	Titanium alloy
Diameter (mm)	3.75
Height (mm)	0.5,1,2,3,4,5
Angle (°)	0
Sterility	Non-sterile

Multi-Unit

Feature	Noris Medical
K510	K140440
Product Name	Multi-Unit
Intended use	The Multi-Unit Abutment is a prosthetic device that fits
only the 2.42 mm internal Hex implants. The device
has been developed for long-term, permanent use.
The Multi-Unit system provides a solution for screw-
retained prosthetic rehabilitation
Material	Titanium alloy
Diameter (mm)	4.9 Straight
3.75 Angled
Height (mm)	1,2,3,4
Angle (°)	0, 17, 30
Sterility	Non-sterile

Prosthetic Combination

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Image /page/19/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 size and also in gray.

Noris Medical prosthetics for Cortical implant is same as predicate deviceTuff implant(K140440). Same platform, same internal Hex connection.

As with the Noris Medical predicate submission (K140440), the complete set of prosthetics already registered is compatible with the subject device, and provides for a complete implantation procedure.

7. NON-CLINICAL TEST

Biocompatibility

The Noris Medical Dental Implant is manufactured from medical grade Titanium alloy per ASTM F136.

SEM and Surface analysis (EDS) after RBM process demonstrated the morphology and cleanliness of the final product.

Biocompatibility risk assessment is leveraged to the Reference predicate device K151909 - Noris Medical Ltd

Sterilization validation tests were conducted in compliance with ANSI/AAMI/SO 11137-1 and ISO 11137-2 in order to ensure safety and effectiveness related to Noris Medical Dental Implants System.

Test results have demonstrated that the SAL of 10-6 was achieved and all testing requirements were met.

Pyrogenicity information provided is based on FDA Guidance on "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submission for Devices Labeled as Sterile." The method used to determine the device meets pyrogen limit specifications is LAL Endotoxin Analysis with testing limit of 20 EU/device, based on USP 161.

The outer packaging and packaging materials constituting the sterile barrier are unchanged and are identical to the packaging used for the predicate K140440 - Noris Medical Ltd.

Transportation: A transportation simulation followed by visual inspection were made to assure the proposed packaging modification survives transportation conditions, in accordance with ASTM 4332 and ASTM D 4169.

Accelerated aging per ASTM-F-1980 have been applied on the final packaging followed by validating package integrity tests for the sterile barrier in order to substantiate 5 years shelf life.

Performance test: Static and dynamic compression performance test was conducted per ISO 14801 Dentistry-Implants-Dynamic fatigue test for Endosseous Dental implants. The worst-case scenario was chosen based on the FDA guideline "Class II Special Controls Guidance Document: Root form for Endosseous dental implants and Endosseous dental Implant Abutments".

The results of the testing indicate that the Noris Medical Dental Implant is substantially equivalent to the predicate devices in this submission.

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Image /page/20/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 company name, the text "Dental Implant Solutions" is written in a smaller, lighter gray font.

8. CLINICAL TEST

Summary: OUS retrospective clinical study in which 40 Noris cortical implants were placed in 19 patients, 9 Male and 10 Female, ages 49-82 (average age 69) during years 2018-2019 in Israeli private clinic. The sample population was statistically derived as n=38. For inclusion in study, all patients required extraction and immediate placement of subject implant with immediate loading. Panoramic radiographs and CT were taken pre-op, along with panoramic radiographs taken immediately after implantation and after at least 6 months follow up. Radiographs provided baseline crestal bone height data for each patient case, with crestal bone level being measured from the base of the smooth, unmachined basket portion of implant body as the subject device is a tissue level device. Specific tooth crestal bone height measurements are provided for selected teeth from each panoramic film, serving as key teeth measured at baseline, 12 months and as late as 33 months. At subsequent patient evaluations, bone loss is calculated based on the total cortical dental implant length minus the 4 mm length of the smooth surface basket.

Acceptance Criteria: Pass Criteria for 1 Year ≤1mm; for 2 Years