(459 days)
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 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 scope of this submission is Noris Medical Cortical Implant as 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. Made of titanium alloy Ti 6Al 4V ELI.
Here's an analysis of the acceptance criteria and the study that proves the Noris Medical Dental Implants System - Cortical meets those criteria, based on the provided FDA 510(k) summary:
Overview
The provided document is a 510(k) Summary for the Noris Medical Dental Implants System - Cortical. The core purpose of a 510(k) submission is to demonstrate that a new medical device is "substantially equivalent" to a legally marketed predicate device, meaning it is as safe and effective. In this case, the clinical test section details a study that supports the safety and effectiveness of the implant with respect to a specific performance criterion: marginal bone loss. The non-clinical tests (biocompatibility, sterilization, performance testing) also contribute to demonstrating substantial equivalence but are not the focus of a comparative clinical performance criterion for this device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion (Clinical Performance) | Reported Device Performance (Clinical Study) |
|---|---|
| Marginal Bone Loss (MBL) at 1 Year: ≤ 1.0 mm | Average MBL at 12 months: 0.6 mm |
| Marginal Bone Loss (MBL) at 2 Years: < 1.2 mm | Average MBL at >24 months for 11/19 patients: 0.6 mm (same as 12 months, implying it remained below 1.2mm) |
| Marginal Bone Loss (MBL) at 3 Years: < 1.4 mm | Data not explicitly reported for 3 years, but 11/19 patients followed for >24 months with consistent 0.6mm average. |
| Overall accuracy: ± 0.25 mm (likely refers to measurement accuracy, not MBL performance) | Not explicitly detailed for this criterion, but the MBL values are presented with a standard deviation. |
| Continuous stability of implant with no inflammation after at least 6 months | 100% survival rate of implants. Implied absence of significant inflammation that would lead to instability/failure. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 40 Noris cortical implants were placed in 19 patients. The document states "The sample population was statistically derived as n=38" which is a bit ambiguous; it likely refers to the minimum required sample size for the study to achieve statistical significance, with 40 implants actually being tested.
- Data Provenance:
- Country of Origin: Israel ("Israeli private clinic").
- Retrospective or Prospective: Retrospective clinical study.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not specify the number of experts or their qualifications for establishing ground truth (specifically, measuring crestal bone height/loss). Measurements were taken from panoramic radiographs and CT scans. It's common in such retrospective studies that image analysis is performed by the researchers or a trained technician, often validated by a clinician. However, this detail is not provided.
4. Adjudication Method for the Test Set
The document does not specify an adjudication method. Since it's a retrospective study, it's possible that data was collected and analyzed by a single party or an unadjudicated team.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was it done?: No. This study is an observational clinical study assessing the performance of the Noris Medical Dental Implants System - Cortical in a real-world setting, focusing on marginal bone loss and survival rate. It does not involve human readers comparing AI-assisted vs. non-AI-assisted diagnosis or treatment.
- Effect size of improvement with AI vs. without AI assistance: Not applicable, as this was not an AI-assisted MCMC study.
6. Standalone (Algorithm-Only) Performance Study
- Was it done?: No. This device is an endosseous dental implant, a physical medical device, not a software algorithm. Therefore, "standalone" performance in the context of an algorithm is not relevant. The performance (e.g., marginal bone loss) is an inherent characteristic of the physical implant itself when used in patients.
7. Type of Ground Truth Used
- Clinical Outcomes/Measurements: The ground truth for the clinical study was established through quantitative measurements of crestal bone height and subsequent calculation of marginal bone loss from panoramic radiographs taken at baseline and follow-up intervals (e.g., 6, 12, 24, and up to 33 months). Implant survival (100%) was also a key outcome.
- Note: The document mentions "Adjudication method (e.g. 2+1, 3+1, none) for the test set" in the prompt template, which implies a study where human readers interpret data. In this clinical study, measurements are taken directly from images or clinical observation, not through a diagnostic interpretation process that requires expert consensus adjudication in the same way an AI diagnostic algorithm might.
8. Sample Size for the Training Set
- Not applicable. This report describes a physical medical device (dental implant), not a machine learning or AI algorithm that requires a training set. The clinical study described served as a test/validation set for the device's performance in humans.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. See point 8.
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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)
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 |
| ClassificationName: | Endosseous dental implant |
| Class: | Implant, Endosseous, Root-Form |
| Product Code: | II |
| CFR section: | DZE |
| Device panel: | 21 CFR 872.3640 |
| Legally MarketedPredicate Device: | Dental |
| Legally MarketedReference Devices: | K140440 - Noris Medical Ltd |
| Submitter: | K140091 MegaGen Implant Co., Ltd., K200586Straumann 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 LtdRA/QA ConsultantM: +972 52-654-6625T: +972 (73) 796-4477F: +972 (4) 695-0991E:simhasibony@gmail.com |
| Mr. Udi Dailes - VP ExecutiveNoris Medical Ltd8 Hataasia St. Nesher 3688808ISRAELT: +972(54)2626719F: +972(4)695-0991E: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
-
- 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.
- 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 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.
- 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-
-
- 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 | SubjectDevice/PresentSubmission | PredicateDevice | Reference Device1 | Reference Device2 | EquivalentorIdentical |
|---|---|---|---|---|---|
| 510(k) Number | K210852 | K140440 | K140091 | K200586 | - |
| Device Name | Noris MedicalDental ImplantsSystem -Cortical | Noris MedicalDental ImplantsSystem - TUFF | Xpeed AnyRidgeInternal ImplantSystem | Straumann TLXImplant System-TLX S | - |
| Sponsor/Manufacturer | Noris Medical Ltd | Noris Medical Ltd | MegaGen ImplantCo., Ltd | Institut StraumannAG | - |
| 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 | SubjectDevice/PresentSubmission | PredicateDevice | Reference Device1 | Reference Device2 | EquivalentorIdentical |
| Target Population | Edentulous orpartiallyedentulousindividuals | Edentulous orpartiallyedentulousindividuals | Edentulous orpartiallyedentulousindividuals | Edentulous orpartiallyedentulousindividuals | SE |
| Material | Titanium alloy | Titanium alloy | CP Ti Grade 4 | Titanium-13Zirconium 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, 5.4,5.9For low ridge: 6.4,6.9, 7.4, 7.9, 8.4 | 3.75, 4.0, 4.5, 5.0,5.5, 6.5 | Identical to Predicateand Ref.1.The Subject deviceis for Normal ridgeonly |
| Full Body Length[mm]- L1 | For Ø4.0: 11.5, 13,16, 18, 20For Ø5.0: 11.5,13.0, 16.0For Ø6.0: 11.5,13.0, 16.0 | 8, 10, 11.5, 13, 16 | 8.5, 10, 11.5,13,15 | 11.3, 13.3,15.3,17.3, 19.3 | SE |
| Feature | SubjectDevice/PresentSubmission | PredicateDevice | Reference Device1 | Reference Device2 | EquivalentorIdentical |
| ImplantedLength [mm]- LLength within thebone(and surfacetreated forosseointegration) | For Ø4.0:7.5, 9, 12, 14, 16For Ø5.0:7.5, 9, 12For Ø6.0:7.5, 9, 12 | For Ø3.3, Ø3.75,Ø4.2, Ø5:8, 10, 11.5, 13, 16For Ø6:8, 10, 11.5,13 | For Ø 4.0, Ø 4.4,Ø 4.9, Ø 5.4,Ø5.9:7,8.5,10,11.5,13,15For Ø 6.4:7, 8.5, 10, 11.5, 13 | For Ø3.75: 6, 8, 10,12, 14, 16, 18For Ø4.5: 8, 10, 12,14, 16, 18For Ø5.5: 8,10,12 | Equivalent topredicate and Ref.1+2 |
| Threaded Length[mm]-L-L3 | For Ø4.0:6.8, 8,10, 11,12.5For Ø5.0:6.8, 8, 10For Ø6.0:6.8, 8, 10 | NA | For normal ridge(Ø3.5-5.5):7.7, 9.2, 10.7,12.2, 14.2, 17.2For low ridge(Ø6-8):7.9, 9.4, 10.9, 12.4,14.4 | For Ø3.75:7, 8.3, 10.3, 12.3,14, 16For Ø4.5:7, 8.3, 10.3, 12.3,14, 16For Ø5.5:7, 8.3, 10.3 | Equivalent to Ref. 2 |
| Feature | SubjectDevice/PresentSubmission | PredicateDevice | Reference Device1 | Reference Device2 | EquivalentorIdentical |
| Gingival (Cuff) Height -[mm]- L2 | 4 | NA | NA | 3.3 | Equivalent to Ref. 2 |
| Basket (Noris Corticalname).Tulip (StraumannTLX name)Non-treated /smoothSection | |||||
| Thread to ShoulderHeight [mm]- L3Neck- surface treatedrough Endosseous andNon-Threaded Section | For L7.5: 0.7For L9: 1.0For L12: 2.0For L14: 3.0For L16: 3.5 | NA | NA | For L8: 1.0For L10, L12, L14:1.7For L16, L18: 2.0 | Equivalent to Ref. 2For Differencediscussion-seebelow |
| Thread Pitch [mm]- P | For Ø4.0: 2.4For Ø5.0: 2.8For Ø6.0: 3 | NA | 1 | For Ø3.75: 1.7, 2.2,2.6For Ø4.5: 2.0, 2.5,2.8For Ø5.5: 2.1, 2.5For Ø6.5: 2.5,2.8 | Equivalent to Ref. 2 |
| Feature | SubjectDevice/PresentSubmission | PredicateDevice | Reference Device1 | Reference Device2 | EquivalentorIdentical |
| Implant ThreadsDepth [mm]at CoreDiameter( 3.5mm belowBone level) | For Ø4.0:0.4, 0.45, 0.45, 0.5,0.5For Ø5.0:1.04, 0.95, 1For Ø6.0:1.25, 1.2, 1.2 | NA | For Ø4.0: 0.35For Ø4.4: 0.35For Ø4.9: 0.6For Ø5.4: 0.85For Ø5.9: 1.1For Ø6.4: 1 | NACannot becalculated - nodata | Higher thread depthfor subject device incomparison to Ref.1Differencediscussion-seebelow |
| ProstheticConnection | Internal Hex | Internal Hex | Internal Hex | TorcFit (withconical fitting) | Identical to predicate |
| Type | Tissue levelimplant | Bone level Implant | Bone level Implant | Tissue levelimplant | Identical to Ref 2 |
| External corebody | Tapered core | Tapered core | Tapered core | Tapered core | Identical to predicate |
| Design threadprofile | Root Form | Root Form | Root Form | Root Form | SE |
| SurfaceTreatment | RBM (ResorbableBlasting Media) | S.L.A (Sand-blasted, Large grit,Acid-etched). | S.L.A (Sand-blasted,large grit, Acid-etched). | HydrophilicSLActive® | Identical toReference K151909 |
| Feature | SubjectDevice/PresentSubmission | PredicateDevice | Reference Device1 | Reference Device2 | Equivalentorldentical |
| Sterilization | Gamma IrradiationSterilization | Gamma IrradiationSterilization | Gamma IrradiationSterilization | Gamma IrradiationSterilization | Identical to Predicate |
| Shelf Life | 5 Years | 5 Years | 5 Years | 5 Years | Identical to Predicate |
| Clinicalprocedure | Immediate loadingor for loading aftera conventionalhealing period | Immediate loadingor for loading aftera conventionalhealing period | Two stages, root-form dentalimplants,associated withabutmentsystems, whichprovide theclinician with thescrew and cementretainedrestoration formulti-mountoptions | N/A | Identical to Predicate |
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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 aroundimplants. | |
| 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 axisof the implant is required. Normally used forconstructing 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 screwretained rehabilitation process on single or multipleunits. |
| 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 securea 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 tosecure 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 fitsonly the 2.42 mm internal Hex implants. The devicehas 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 Straight3.75 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<1.2mm; for 3 Years <1.4mm, with overall accuracy ±0.25mm. A continuous stability of implant with no inflammation after at least 6 months was considered as a success.
Implants were placed in both anterior and posterior of both mandible and maxilla. Implant full body lengths used consisted of 11.5mm, 16mm and 18mm. All implants were placed in extraction sockets in bone density consisting of types III- IV (low density cancellous bone) with immediate restoration and occlusal loading. Results: All patients were followed at least 12 months post-loading, with 11/19 followed more than 24 months for evaluation of marginal bone loss at 12 months and 24 months. Results showed 100% survival rate of implants with average marginal bone loss of 0.6mm with a standard deviation of 0.57mm.
9. SUMMARY OF SUBSTANTIAL EQUIVALENCE
The Noris Medical Cortical Implant and its predicate and reference devices share equivalent intended use, and technological features, as described hereunder:
Intended Use
Both TUFF and Cortical Implant (Noris) devices are intended to be implanted in either jaw arch to provide support for fixed or removable prosthetic devices in patients with partially or fully edentulous maxillae.
Technoloqical Features
The subject device material uses ASTM-F136 medical Grade Titanium alloy identical to the predicate device material.
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Image /page/21/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. The logo is clean and modern, with a focus on the company's name and its specialization in dental implants.
Biocompatibility risk assessment is leveraged to predicate device K151909 therefore, no new issues regarding biocompatibility were raised.
Calcium phosphate blasted(RBM) is used for surface modification all Noris Medical dental implants system to increase bone-implant interface, and hence facilitate ossointegration.
RBM surface treatment was cleared under K151909-Noris Medical Zygomatic dental implant System
The Noris Medical SEM/EDS surface analysis test results showed clean surface with morphology that conforms to RBM process
The Noris Cortical implant subject device is packed in a sterile barrier packaging and is equivalent to the validated packaging of the TUFF predicate device K140440.
The Gamma radiation sterilization process used for the Cortical Implant subject device as recommended in the labeling was validated for TUFF predicate device and is providing sterile implants with Sterility Assurance Level (SAL) of 10-6
The validation method used was the over kill bioburden method in accordance with ISO 11137-2, "Sterilization of health care products – Radiation – Part 2: Establishing the sterilization dose".
The shelf life for the devices provided sterile is 5 years and is equivalent to predicate device TUFF implant.
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 devices will not be marketed as non-pyrogenic
Biological assessment for final product has been performed according to ISO 10993-1:2009 "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process" and to the FDA Guidance document "Use of International Standard ISO 10993- 1'Biological evaluation of medical devices -Part 1"
Dynamic fatique tests were conducted according to ISO 14801 and the FDA quidance document "Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments" and demonstrated the fatigue limit and Maximum bending moment of Cortical Implant combined to worst case abutment connection is equivalent to the predicate device K140440.
CONCLUSION 10.
Noris Medical Cortical Dental Implant System and its predicate device Noris Medical TUFF implant is intended for the same use, and are implanted using equivalent surgical procedures.
The Noris Medical Cortical implant external shape design is similar to reference device 1 AnyRidge Megagen for the threads design and to reference device 2 Straumann TLX for the restoration portion and neck implant design.
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Image /page/22/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 words "NORIS Medical" in gray. Below that, the words "Dental Implant Solutions" are written in a smaller, lighter gray font.
The minor differences between Noris Medical Cortical Dental Implant System to the predicate and reference predicates do not raise new concerns of safety or effectiveness. The Noris Medical Cortical implant System subject device is substantially equivalent, for the relevant features, to predicate device and Reference devices.
The proposed Cortical Implant, predicate and reference devices have common characteristics in all the items in the comparison chart except absolute dimensions such as the Diameter, Length and Gingival (Cuff) Height. These differences are explained not affecting the substantial equivalence.
Fatigue test was performed on the subject device and predicate device to confirm the substantial equivalence with combination of the worst-case fixture and abutment, according to 'ISO 14801' and 'Class II Special Controls Guidance Document: Rootform Endosseous Dental Implants and Endosseous Dental Implant Abutment' to figure out the mechanical property. The test result supports the substantial equivalence to the predicate device.
On the basis of the comparison charts and discussion above, it is concluded that the subject device is substantially equivalent to its predicate and reference devices.
§ 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.