(133 days)
Noris Medical Ltd. Conical Platform Dental Implants System is intended to replace missing tooth/teeth in either jaw for supporting prosthetic devices that may aid in restoring the patient's chewing function.
Noris Medical Ltd. Conical platform Dental Implants diameter 3.25 are intended to replace lateral incisor in Maxilla and/or a central or lateral incisor in the mandible for supporting prosthetic devices that may aid in restoring the patient's chewing function.
The procedure can be accomplished in a one-stage surgical operation. All impants are appropriate for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
The subject dental implant devices are single use devices, provided sterile by Gamma Radiation, made of Titanium alloy Ti- 6Al-4V ELI (ASTM F136). The UniCon and Tuff Unicon Implants are designed with conical connection comprises of cone and internal hex connection, diameters of 3.25, 3.5, 3.75 and 4.2 mm and lengths of 8, 10, 11.5, 13, 16 and 18 mm. Both Implants are designed with three thread zones, the Tuff UniCon with lower V-shape thread zone and UniCon with sharp buttress threads enables self-tapping. The middle zone square type thread of Tuff UniCon and wide edge buttress of UniCon is used for compressing cancellous bone. The micro threads on the upper zone enables less pressure on the crestal bone. The subject devices undergo RBM (Resorbable Blasting Media) surface treatment and color anodization within its connection for the purpose of color coding. It is indicated to replace missing tooth/teeth in either jaw for supporting prosthetic devices that may aid in restoring the patient's chewing function. The Implants Diameter Ø3.25 are intended to replace lateral incisor in maxilla and/or a central or lateral incisor in the mandible for supporting prosthetic devices that may aid in restoring the patient's chewing function.
Healing Caps are Titanium devices mounted onto the dental implant before the soft tissue is sutured around the implant and are intended to protect the implant bore. The Subject Healing Cap with the conical connection fits the UniCon and Tuff Unicon Implants. It is single use device, non-sterile and made of Titanium alloy Ti- 6Al-4V ELI (ASTM F136). The Healing Cap provided with 4.3mm, 4.8mm and 5.2mm Diameter and 4.5mm, 5.5mm, 6.5m, 7.5mm, 8.5mm External Body Height. The subject device undergoes color anodization.
The Subject Abutments (temporary, straight, angular and screw retained) with the conical connection fits the UniCon and Tuff UniCon Implants. It is single use device, non-sterile and made of Titanium alloy Ti- 6Al-4V ELI (ASTM F136). The subject device undergoes color anodization. The abutments are provided in different types and dimensions.
Multi-Unit Straight/Angular Screw Retained abutment are intended to function in the mandible or maxilla to support multiple-unit temporary or permanent restorations on Noris dental implants. The Subject Abutments with the conical connection fits the UniCon and Tuff UniCon Implants. It is single use device, non-sterile and made of Titanium alloy Ti- 6Al-4V ELI (ASTM F136). The subject device undergoes color anodization.
The abutment screw is intended to fasten the abutment to a dental implant. The Subject Abutments screw with the conical connection fits the UniCon and Tuff Unicon Implants. It is single use device, non-sterile and made of Titanium alloy Ti- 6Al-4V ELI (ASTM F136). The Abutments screw provided with 2mm Diameter and 7.3 mm Length. The subject device undergoes color anodization.
Cover screw- Healing Caps and Cover Screws are Titanium devices mounted onto the dental implant before the soft tissue is sutured in place around the implant and which are intended to protect the implant bore. The Subject Cover screw with the conical connection fits the UniCon and Tuff Unicon Implants. It is single use device, non-sterile and made of Titanium alloy Ti- 6Al-4V ELI (ASTM F136). The cover screws are provided with 3.2mm, 3.5mm Diameters and 4.9 mm Length. The subject device undergoes color anodization.
Based on the provided FDA 510(k) summary for the "Conical Platform Dental Implants System," here's a breakdown of the acceptance criteria and the study that proves the device meets them:
Important Note: This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device. This is different from a PMA (Premarket Approval) application, which requires clinical efficacy and safety studies. Therefore, the "study that proves the device meets the acceptance criteria" in this context refers to non-clinical performance testing and comparisons to predicate devices, rather than a full-scale clinical trial with human subjects. The document primarily focuses on physical and material characteristics and demonstrates equivalence through engineering analyses rather than clinical outcomes with an AI component.
The request asks for information that is more typical of a software as a medical device (SaMD) or AI/ML device approval, such as "number of experts," "adjudication method," "MRMC study," and "training set ground truth." However, this document describes a dental implant system, which is a physical device, and does not mention any AI/ML components. Therefore, many of the requested points related to AI/ML device evaluation are not applicable or cannot be found in this submission. I will address the points that are applicable to this type of device and note where information is not present in the provided text.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for this physical device are primarily based on demonstrating substantial equivalence to predicate devices in terms of design, materials, indications for use, and performance testing (specifically fatigue).
| Feature / Performance Metric | Acceptance Criteria (demonstrated by) | Reported Device Performance (as demonstrated in submission) |
|---|---|---|
| Indications for Use | Substantially equivalent to predicate devices (Noris Medical Ltd. - Tuff (K140440), Nobel Biocare – NobelActive ® (K142260), Paltop Advanced Dental Solutions Ltd. - PCA (K130462)). | "Noris Medical Ltd Conical Platform Dental Implants System is intended to replace missing tooth/teeth in either jaw for supporting prosthetic devices that may aid in restoring the patient's chewing function." Specific mention for Ø3.25 implants for lateral incisor in maxilla and/or central/lateral incisor in mandible. Similar to predicates. |
| Material | Titanium alloy Ti-6Al-4V ELI (ASTM F136) for implants, healing caps, abutments, Multi-Unit abutments, abutment screws, cover screws. Must be biocompatible. | All components consistently listed as Titanium alloy Ti-6Al-4V ELI. Biocompatibility leveraged from K151909 (Noris Medical Ltd. - Zygomatic Implants), indicating identical material/manufacturing/surface treatments. |
| Design | Conical connection, specific diameters and lengths as per product range. Threaded root-form implant design. Must be comparable to predicate designs. | Detailed descriptions of UniCon and Tuff UniCon implants (conical connection, internal hex, diameters: 3.25, 3.5, 3.75, 4.2mm; lengths: 8, 10, 11.5, 13, 16, 18mm). Detailed descriptions of healing caps, abutments, and screws with specified dimensions. Comparisons to predicates show similar design descriptions. |
| Surface Treatment | RBM (Resorbable Blasting Media) for implants. Color anodization for connection (implants) and Gold anodization for prosthetic devices/screws. | Implants: RBM and color anodization. Prosthetic devices/screws: Gold anodization. This is either identical or demonstrably equivalent to predicates. |
| Sterilization | Gamma Radiation for implants. Non-sterile for other components (healing caps, abutments, screws). Reprocessing sterilization for prosthetic devices/screws must be leveraged from previously cleared devices. | Implants are sterile (Gamma Radiation). Healing caps, abutments, screws are non-sterile. Reprocessing sterilization for the unsterile components was leveraged from K140440 (primary predicate), indicating the same material and design. |
| Single Use | All components identified as single use. | All listed components (implants, healing caps, abutments, screws) are explicitly stated as "Yes" for Single Use. |
| Fatigue Strength | Must meet ISO 14801 standards. | "Fatigue tests per ISO 14801 were performed to determine the fatigue strength for UniCon implants, according to FDA Guidance." (No specific numerical results given, but the test was performed and implies compliance). |
| Pyrogen Limits | Must meet pyrogen limits specifications (e.g., USP <85>). | "Pyrogen limits specifications are monitored at set intervals. Test was leveraged since there is no change from previously cleared devices in K140440. The method used to make the determination that the device meets pyrogen limits specifications is based on USP <85>." |
| MRI Safety | Assessment of magnetically induced displacement force and torque based on scientific rationale and published literature, compliant with FDA Guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment." | "Non-clinical worst-case MRI review was performed... using scientific rationale and published literature... based on the entire system including all variations... Rationale addressed parameters per the FDA Guidance... including magnetically induced displacement force and torque." |
2. Sample Size Used for the Test Set and Data Provenance
Since this is a physical device and the primary evidence provided is non-clinical performance data (fatigue testing, material characterization, etc.) rather than a clinical study with a "test set" of patients, the concept of a sample size for a test set and data provenance (country, retrospective/prospective) as it applies to AI/ML or clinical trial data isn't directly applicable here in the same way.
- Sample Size for Testing: The document states that "Fatigue tests per ISO 14801 were performed to determine the fatigue strength for UniCon implants." ISO 14801 specifies the number of samples for fatigue testing (typically 6-12 samples per group, depending on the desired confidence and methodology), but the exact number used is not explicitly stated in this summary. Other tests (biocompatibility, reprocessing, pyrogen, MRI review) were leveraged or based on scientific rationale, meaning new physical samples were likely not tested for these aspects as equivalence to previously cleared devices was the basis.
- Data Provenance: Not applicable in the context of a clinical test set for a physical device where the primary evaluation is non-clinical. The company is Noris Medical Ltd., located in Nesher, Israel.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This question is highly relevant for AI/ML devices where "ground truth" often involves expert annotation or consensus. For this physical dental implant device, ground truth is established through:
- International Standards: e.g., ISO 14801 for fatigue testing, ASTM F136 for material specifications. These standards define the "ground truth" for material properties and mechanical performance.
- Regulatory Guidance: e.g., FDA Guidance for MRI safety, USP <85> for pyrogen limits. These guidances define the acceptable methodology and results.
- Predicate Device Characteristics: The comparison of technological characteristics to predicate devices (K140440, K142260, K130462) establishes the "ground truth" for substantial equivalence.
There is no mention of human experts defining "ground truth" in the way it's done for diagnostic image interpretation by multiple radiologists. The expertise lies within the material science, mechanical engineering, and regulatory compliance teams that designed the device and conducted/evaluated the non-clinical tests.
4. Adjudication Method for the Test Set
Not applicable. There is no human interpretation or subjective assessment of a test set that would require an adjudication method like 2+1 or 3+1. Performance is measured against objective engineering standards and direct comparison of physical/material characteristics.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No. An MRMC study is specific to diagnostic imaging devices, particularly those involving human interpretation of medical images, often assisted by AI. This document pertains to a physical dental implant system and therefore, this type of study was not conducted or required. No AI assistance or human reader improvement is mentioned.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done
Not applicable. This device is a physical dental implant system and does not involve an algorithm or AI component.
7. The Type of Ground Truth Used
The "ground truth" for this device application is primarily based on:
- Engineering Standards: Specific material properties, mechanical performance (e.g., fatigue strength as per ISO 14801), and dimensional tolerances.
- Predicate Device Characteristics: The established safety and effectiveness of the chosen predicate devices serve as the benchmark for demonstrating substantial equivalence for the new device's indications for use, materials, and design.
- Leveraged Data: For biocompatibility, reprocessing sterilization, and pyrogen limits, the "ground truth" is that the material, manufacturing, and surface treatments are identical to previously cleared devices (K151909 and K140440), therefore their established safety and performance data (ground truth) is directly applicable.
No pathology reports or patient outcomes data as "ground truth" are mentioned in this 510(k) summary, as it relies on non-clinical data for substantial equivalence.
8. The Sample Size for the Training Set
Not applicable. There is no AI/ML component described, so there isn't a "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no AI/ML component or training set described.
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Noris Medical Ltd. Noa Mor Regulatory Affairs Director 8 Hataasia St. Nesher, 3688808 ISRAEL
June 6, 2024
Re: K240202
Trade/Device Name: Conical Platform Dental Implants System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: May 7, 2024 Received: May 7, 2024
Dear Noa Mor:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration. listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products: and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
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For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatory-
assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Andrew I. Steen -S
Andrew I. Steen Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
K240202
Device Name
Conical Platform Dental Implants System
Noris Medical Ltd. Conical Platform Dental Implants System id intended to replace missing tooth/teeth in either jaw for supporting prosthetic devices that may aid in restoring the patient's chewing function.
Noris Medical Ltd. Conical platform Dental Implants diameter 3.25 are intended to replace lateral incisor in Maxilla and/or a central or lateral incisor in the mandible for supporting prosthetic devices that may aid in restoring the patient's chewing function.
The procedure can be accomplished in a one-stage surgical operation. All impants are appropriate for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/4/Picture/0 description: The image contains the logo for Noris Medical Dental Implant Solutions. The logo consists of a red abstract shape on the left, followed by the text "NORIS Medical" in gray. Below the text is the phrase "Dental Implant Solutions" in a smaller, lighter gray font. The logo is clean and professional, suggesting a focus on medical and dental products.
510k Summary (K240202)
l. SUBMITTER
Noris Medical Ltd. 8 Hataasia St. 3688808 Nesher, Israel
Phone: 972-73-7964477
Contact Person: Noa Mor Date Prepared: June 05, 2024
II. DEVICE
Name of Device: Conical Platform Dental Implants System Common or Usual Name: Conical Platform Dental Implants System Classification Name: Endosseous dental implant (21 CFR 872.3640) Regulatory Class: II Product Code: DZE Associated Product Code: NHA
PREDICATE AND REFERENCE DEVICES lll.
Noris Medical Ltd. - Tuff (K140440 Primary Predicate) Nobel Biocare – NobelActive ® (NP-Narrow Platform) (K142260 Reference Device) Paltop Advanced Dental Solutions Ltd. - PCA (NP- Narrow Platform) (K130462 Reference Device)
Noris Medical Ltd. - Zygomatic Implants (K151909 Reference Device for Biocompatibility)
IV. DEVICE DESCRIPTION
- a) Dental Implants- The subject dental implant devices are single use devices, provided sterile by Gamma Radiation, made of Titanium alloy Ti- 6Al-4V ELI (ASTM F136). The UniCon and Tuff Unicon Implants are designed with conical connection comprises of cone and internal hex connection, diameters of 3.25, 3.5, 3.75 and 4.2 mm and lengths of 8, 10, 11.5, 13, 16 and 18 mm. Both Implants are designed with three thread zones, the Tuff UniCon with lower V-shape thread zone and UniCon with sharp buttress threads enables self-tapping. The middle zone square type thread of Tuff UniCon and wide edge buttress of UniCon is used for compressing cancellous bone. The micro threads on the upper zone enables less pressure on the crestal bone. The subject devices undergo RBM (Resorbable Blasting Media) surface treatment and color anodization within its connection for the purpose of color coding. It is indicated to replace missing tooth/teeth in either jaw for supporting prosthetic devices that may aid in restoring the patient's chewing function. The Implants Diameter Ø3.25 are intended to replace lateral incisor in maxilla and/or a
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Dental Implant Solution
central or lateral incisor in the mandible for supporting prosthetic devices that may aid in restoring the patient's chewing function.
- Healing Cap Healing Caps are Titanium devices mounted onto the dental implant b) before the soft tissue is sutured around the implant and are intended to protect the implant bore. The Subject Healing Cap with the conical connection fits the UniCon and Tuff Unicon Implants. It is single use device, non-sterile and made of Titanium alloy Ti- 6Al-4V ELI (ASTM F136). The Healing Cap provided with 4.3mm, 4.8mm and 5.2mm Diameter and 4.5mm, 5.5mm, 6.5m, 7.5mm, 8.5mm External Body Height. The subject device undergoes color anodization.
- c) Abutments (temporary, straight, angular and screw retained)- The Subject Abutments with the conical connection fits the UniCon and Tuff UniCon Implants. It is single use device, non-sterile and made of Titanium alloy Ti- 6Al-4V ELI (ASTM F136). The subject device undergoes color anodization. The abutments are provided in different types and dimensions; The straight abutment is used in the fabrication of cement-retained restorations, single crowns or bridges. Straight abutments with shoulder are provided with 4.5mm Diameter and 9mm, 10mm, 11mm,12mm External Body Height. Straight abutments are provided with 5mm Diameter and 9mm, 12mm External Body Height. Angular abutments are used when a change to the axis of the implant is required. Normally used for constructing cement-retained single crowns or bridges. Angular Abutment are provided with 4.1mm, 4.4mm Diameter and 9mm, 11mm External Body Height and 15° and 25° degrees angle. The Flat attachment superstructure is intended to secure an overdenture. Flat attachments are provided with 3.87 mm diameter and are suitable for gingival heights* of 0.5mm, 1mm, 2mm, 3mm, 4mm, and 5mm. Temporary Titanium Abutments are screwed into the dental implants. They serve as a base for a temporary prosthetic restoration. Non-engage Temporary abutment and Temporary abutment are provided with 4.3mm Diameter and 9.5mm External Body Height.
- Multi-Unit Straight/Angular Screw Retained abutment- Multi-Unit Abutments are d) intended to function in the mandible or maxilla to support multiple-unit temporary or permanent restorations on Noris dental implants. The Subject Abutments with the conical connection fits the UniCon and Tuff UniCon Implants. It is single use device, non-sterile and made of Titanium alloy Ti- 6Al-4V ELI (ASTM F136). The subject device undergoes color anodization. The Multi-Unit straight Screw Retained abutments are provided with 4.9mm Diameter and 1.5mm, 3.5mm, 4.5mm, 5.5mm Collar Height and the Multi-Unit Angular Screw Retained abutments are provided with 4.9mm Diameter and 2mm, 2.5mm Gingival Height and 17, 30 degrees angle.
- Abutments screw- The abutment screw is intended to fasten the abutment to a e) dental implant. The Subject Abutments screw with the conical connection fits the UniCon and Tuff UniCon Implants. It is single use device, non-sterile and made of Titanium alloy Ti- 6Al-4V ELI (ASTM F136). The Abutments screw provided with 2mm Diameter and 7.3 mm Length. The subject device undergoes color anodization.
- Cover screw- Healing Caps and Cover Screws are Titanium devices mounted onto the f) dental implant before the soft tissue is sutured in place around the implant and which are intended to protect the implant bore. The Subject Cover screw with the conical connection fits the UniCon and Tuff Unicon Implants. It is single use device, non-sterile and made of Titanium alloy Ti- 6Al-4V ELI (ASTM F136). The cover screws
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Image /page/6/Picture/0 description: The image is a logo for Noris Medical Dental Implant Solutions. The logo consists of a red abstract shape on the left, followed by the words "NORIS Medical" in gray. Below "NORIS Medical" is the text "Dental Implant Solutions" in a smaller, lighter gray font. The logo is clean and modern, with a focus on the company's name and its specialization in dental implants.
are provided with 3.2mm, 3.5mm Diameters and 4.9 mm Length. The subject device undergoes color anodization.
*Flat Attachment gingival height - the distance from the flat coronal surface of implants with diameters of 3.5 mm, 3.75 mm, and 4.2 mm, measured up to 0.5 mm below the metal cap of the flat attachment. For implants with a diameter of 3.25 mm, this distance is 0.86 mm below the metal cap of the flat attachment.
INDICATION FOR USE V.
Noris Medical Ltd Conical Platform Dental Implants System is intended to replace missing tooth/teeth in either jaw for supporting prosthetic devices that may aid in restoring the patient's chewing function .
Noris Medical Ltd Conical Platform Dental Implants diameter Ø3.25 are intended to replace lateral incisor in maxilla and/or a central or lateral incisor in the mandible for supporting prosthetic devices that may aid in restoring the patient's chewing function. The procedure can be accomplished in a one-stage surgical operation. All implants are appropriate for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
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Image /page/7/Picture/0 description: The image contains the logo for Noris Medical. The logo consists of a red abstract shape on the left and the words "NORIS Medical" in gray on the right. Below "NORIS Medical" is the text "Dental Implant Solutions" in a lighter gray color. There is a registered trademark symbol next to the word Medical.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS VI.
- a. Dental Implants
| SUBJECT DEVICE | SUBJECT DEVICE | PRIMARY PREDICATE | REFERENCE PREDICATE | REFERENCE PREDICATE | |
|---|---|---|---|---|---|
| Device | UniCon | Tuff UniCon | Tuff(K140440) | NobelActive ®(K142260) | PCA(K130462) |
| Noris Medical Ltd. | Noris Medical Ltd. | Noris Medical Ltd. | Nobel Biocare AB | Paltop Advanced Dental SolutionsLtd. | |
| Design Description | Threaded root-form implant to beused with matching abutments. | Threaded root-form implant to beused with matching abutments. | Threaded root-form implant to be usedwith matching abutments. | Threaded root-form implant to beused with matching abutments. | Threaded root-form implant to beused with matching abutments. |
| Indication for Use | Noris Medical Ltd ConicalPlatform Dental Implants Systemis intended to replace missingtooth/teeth in either jaw forsupporting prosthetic devices thatmay aid in restoring the patient'schewing function.Noris Medical Ltd. ConicalPlatform Implants diameter Ø3.25are intended to replace lateralincisor in maxilla and/or a centralor lateral incisor in the mandiblefor supporting prosthetic devicesthat may aid in restoring thepatient's chewing function.The procedure can beaccomplished in a one-stage ortwo-stage surgical operation. Allimplants are appropriate forimmediate loading when goodprimary stability is achieved andwith appropriate occlusal loading. | Noris Medical Ltd Conical PlatformDental Implants System is intendedto replace missing tooth/teeth ineither jaw for supporting prostheticdevices that may aid in restoring thepatient's chewing function.Noris Medical Ltd.Conical PlatformImplants diameter Ø3. 25 areintended to replace lateral incisor inmaxilla and/or a central or lateralincisor in the mandible for supportingprosthetic devices that may aid inrestoring the patient's chewingfunction.The procedure can be accomplishedin a one-stage or two-stage surgicaloperation. All implants areappropriate for immediate loadingwhen good primary stability isachieved and with appropriateocclusal loading. | Noris Medical Ltd Dental Implants Systemis intended to replace missing tooth/teethin either jaw for supporting prostheticdevices that may aid in restoring thepatient's chewing function. The procedurecan be accomplished in a one-stage ortwo-stage surgical operation. All implantsare appropriate for immediate loadingwhen good primary stability is achievedand with appropriate occlusal loading. | NobelActive ® implants areendosseous implants intended tobe surgically placed in the upperor lower jaw bone for anchoring orsupporting tooth replacements torestore patient esthetics andchewing function. NobelActive ®implants are indicated for single ormultiple unit restorations insplinted or non-splintedapplications. This can be achievedby a 2-stage or 1-stage surgicaltechnique in combination withimmediate, early or delayedloading protocols, recognizingsufficient primary stability andappropriate occlusal loading forthe selected technique.NobelActive® 3.0 implants areintended to replace a lateralincisor in the maxilla and/or acentral or lateral incisor in themandible.NobelActive® 3.0 implants areindicated for single unitrestorations only. | The Paltop Narrow implant isindicated for use in surgical andrestorative applications forplacement in the mandibularcentral, lateral incisor andmaxillary lateral incisor regions ofpartially edentulous jaws wherethe horizontal space is limited bythe adjacent teeth and roots, toprovide support for prostheticdevices, such as artificial teeth, inorder to restore the patient'schewing function. The Paltopnarrow implant is indicated also forimmediate loading when goodprimary stability is achieved andwith appropriate occlusal loading |
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Image /page/8/Picture/0 description: The image contains the logo for Noris Medical. The logo consists of a red abstract shape on the left, followed by the text "NORIS Medical" in gray. Below the company name, the text "Dental Implant Solutions" is written in a smaller, lighter gray font.
| SUBJECT DEVICE | SUBJECT DEVICE | PRIMARY PREDICATE | REFERENCE PREDICATE | REFERENCE PREDICATE | |
|---|---|---|---|---|---|
| Device | UniCon | Tuff UniCon | Tuff(K140440) | NobelActive ®(K142260) | PCA(K130462) |
| Noris Medical Ltd. | Noris Medical Ltd. | Noris Medical Ltd. | Nobel Biocare AB | Paltop Advanced Dental SolutionsLtd. | |
| Type | Bone level Implant | Bone level Implant | Bone level Implant | Bone level Implant | Bone level Implant |
| Implant Diameter [mm] | Ø 3.5Ø 3.75Ø 4.2 | Ø 3.25Ø 3.5Ø 3.75Ø 4.2 | Ø 3.75Ø 4.2 | Ø 3.5Ø 4.3 | Ø 3.25 |
| Length [mm] | 8, 10, 11.5, 13, 16,18 | 10, 11.5, 13, 16 For Ø3.258, 10, 11.5, 13, 16, 18 for Ø3.5,Ø3.75, Ø4.2 | 8, 10, 11.5, 13, 16,18 | 8.5, 10, 11.5, 13, 15,18 | 10, 11.5, 13, 16 |
| Material | Titanium alloy Grade 23Ti-6Al-4V ELI | Titanium alloy Grade 23Ti-6Al-4V ELI | Titanium alloy Grade 23Ti-6Al-4V ELI | Commercially Pure TitaniumGrade 4 | Titanium alloy Grade 23Ti-6Al-4V ELI |
| Surface Treatment | RBM (Resorbable Blasting Media) | RBM (Resorbable Blasting Media) | RBM (Resorbable Blasting Media) | TiUnite | Sand blasted and acid etched |
| Sterilization | Gamma Irradiation Sterilization | Gamma Irradiation Sterilization | Gamma Irradiation Sterilization | Gamma Irradiation Sterilization | Gamma Irradiation Sterilization |
| Single Use | Yes | Yes | Yes | Yes | Yes |
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Image /page/9/Picture/0 description: The image shows the logo for NORIS Medical. The logo consists of a red abstract shape on the left, followed by the words "NORIS Medical" in gray. Below the company name, the words "Dental Implant Solutions" are written in a smaller font, also in gray.
b. Healing Cap
| SUBJECT DEVICE | PRIMARY PREDICATE | REFERENCE PREDICATE | |
|---|---|---|---|
| Device | Healing CapConical Platform | Healing CapInternal Hex (Standard Platform)(K140440) | Nobel Active® Healing AbutmentsBridgeConicalConnection NP(NarrowPlatform)(K142260) |
| Noris Medical Ltd. | Noris Medical Ltd. | Nobel Biocare AB | |
| Design Description | Cylindrical shape with concaveemergence profile body.Free-rotation (non-engage) withintegrated screw portion to threaddirectly to the implant.Interface the implant upper face. | Cylindrical shape body.Free-rotation (non-engage) with integratedscrew portion to thread directly to theimplant.Interface the implant internal connectioncone. | Cylindrical shape with concaveemergence profile body.Free-rotation (non-engage) withintegrated screw portion to threaddirectly to the implant.Interface the implant upper face. |
| Material | Titanium alloy Ti-6Al-4V ELI | Titanium alloy Ti-6Al-4V ELI | Titanium alloy |
| Color | Gold Anodize | No Color | Partial Pink Anodize |
| Diameter | 4.3, 4.8, 5.2 | 3.8, 4.6, 5.5, 6.3 | 4 |
| External Body Height*[mm] | 4.5, 5.5, 6.5, 7.5, 8.5For Ø4.3, Ø5.24.5, 5.5, 6.5, 7.5For Ø4.8 | 2, 3, 4, 5, 6, 7 | 3, 5, 7 |
| Angle [°] | 0 | 0 | 0 |
| Sterilization | Non sterile | Non sterile | Sterile |
| Single Use | Yes | Yes | Yes |
- External Body Height - The height from implant most coronal surface
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Image /page/10/Picture/0 description: The image contains the logo for Noris Medical Dental Implant Solutions. The logo consists of a red abstract shape on the left, followed by the text "NORIS Medical" in gray. Below that, the text "Dental Implant Solutions" is also in gray and in a smaller font size.
ﻥ Straight abutment
| SUBJECT DEVICE | PRIMARY PREDICATE | REFERENCE PREDICATE | |
|---|---|---|---|
| Device | Straight abutment with shoulderConical Platform | Straight abutment with shoulderInternal Hex (Standard Platform)(K140440) | Nobel Active Snappy AbutmentsConical Connection NP (NarrowPlatform)(K142260) |
| Noris Medical Ltd. | Noris Medical Ltd. | Nobel Biocare AB | |
| Design Description | Anti-rotation products thatinterface the internal connection ofthe implant and include cone andhexagon (to engage the implant).Shoulder in various heights.These products include dedicatedscrew to connect to the implant. | Anti-rotation products that interface theinternal connection of the implant andinclude cone and hexagon (to engage theimplant). Shoulder in various heights.These products include dedicated screw toconnect to the implant. | Anti-rotation products thatinterface the internal connection ofthe implant and include cone andhexagon (to engage the implant).These products include dedicatedscrew to connect to the implant. |
| Material | Titanium alloy Ti-6Al-4V ELI | Titanium alloy Ti-6Al-4V ELI | Titanium alloy |
| Color | Gold Anodize | No Color | Partial Pink Anodize |
| Diameter | 4.5 | 4.5, 5.5 | 4, 5.5 |
| External Body Height*[mm] | 9,12 | 8.5, 9, 9.5, 10.5, 11, 11.5, 12.5 | 5.5, 7, 8.5 |
| Angle [°] | 0 | 0 | 0 |
| Sterilization | Non sterile | Non sterile | Sterile |
| Single Use | Yes | Yes | Yes |
- External Body Height- The height from implant platform (for 3.5,3.75 and 4.2 diameter implants)
d. Angular Abutment
| SUBJECT DEVICE | PRIMARY PREDICATE | REFERENCE PREDICATE | |
|---|---|---|---|
| Device | Angular abutmentConical Platform | Angular abutmentInternal Hex (Standard Platform)(K140440) | Nobel Active 15° Esthetic AbutmentsConical Connection NP (NarrowPlatform)(K142260) |
| Noris Medical Ltd. | Noris Medical Ltd. | Nobel Biocare AB | |
| Design Description | Anti-rotation products that interfacethe internal connection of theimplant and include cone andhexagon (to engage the implant). | Anti-rotation products that interface theinternal connection of the implant andinclude cone and hexagon (to engage theimplant). | Anti-rotation products that interfacethe internal connection of theimplant and include cone andhexagon (to engage the implant). |
| Material | Titanium alloy Ti-6Al-4V ELI | Titanium alloy Ti-6Al-4V ELI | Titanium alloy |
| Color | Gold Anodize | No Color | Partial Pink Anodize |
| Diameter | 4.1, 4.4 | 4, 4.5 | Not published |
| External Body Height*[mm] | 9,11 | 9, 11 | 8, 9.5, 11 |
| Angle [°] | 15, 25 | 15, 25 | 15 |
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Image /page/11/Picture/0 description: The image shows the logo for Noris Medical Dental Implant Solutions. The logo consists of a red abstract shape on the left, followed by the words "NORIS Medical" in gray. Below "NORIS Medical" are the words "Dental Implant Solutions" in a smaller font, also in gray. The logo is clean and modern, with a focus on the company's name and its specialization in dental implants.
| Device | SUBJECT DEVICE | PRIMARY PREDICATE | REFERENCE PREDICATE |
|---|---|---|---|
| Angular abutmentConical Platform | Angular abutmentInternal Hex (Standard Platform)(K140440) | Nobel Active 15° Esthetic AbutmentsConical Connection NP (NarrowPlatform)(K142260) | |
| Noris Medical Ltd. | Noris Medical Ltd. | Nobel Biocare AB | |
| Sterilization | Non sterile | Non sterile | Sterile |
| Single Use | Yes | Yes | Yes |
- External Body Height- The height from implant platform (for 3.5,3.75 and 4.2 diameter implants)
e. Multi-Unit Angular/Straight Screw Retained abutment
ල
| SUBJECT DEVICE | PRIMARY PREDICATE | REFERENCE PREDICATE | |
|---|---|---|---|
| Device | Multi-Unit Straight Screw RetainedabutmentConical Platform | Multi-Unit Straight Screw Retained abutmentInternal Hex (Standard Platform)(K140440) | Nobel Active Multi-Unit AbutmentConical Connection NP (Narrow XealPlatform)(K142260) |
| Noris Medical Ltd. | Noris Medical Ltd. | Nobel Biocare AB | |
| Design Description | Screw retained shape with concaveemergence profile body.Free-rotation (non-engage) withintegrated screw portion to threaddirectly to the implant.Screw retained restorative portionwith hexagon, cone and internalthread.Interface the implant internalconnection cone. | Screw retained shape with concaveemergence profile body.Free-rotation (non-engage) with integratedscrew portion to thread directly to theimplant.Screw retained restorative portion withhexagon, cone and internal thread.Interface the implant internal connectioncone. | Screw retained shape with concaveemergence profile body.Free-rotation (non-engage) withintegrated screw portion to threaddirectly to the implant.Screw retained restorative portionwith hexagon, cone and internalthread.Interface the implant internalconnection cone. |
| Material | Titanium alloy Ti-6Al-4V ELI | Titanium alloy Ti-6Al-4V ELI | Titanium alloy |
| Color | Gold Anodize | No Color | Gold Anodize |
| Diameter | 4.9 | 4.9 | 4.9 |
| Gingival Height [mm] | Angular: 2, 2.5, 3.5Straight: 1.5, 2.5, 3.5, 4.5, 5.5 | Angular: 2, 3, 4, 5Straight: 1, 2, 3, 4, 5 | Angular: 2.5, 3.5, 4.5Straight: 1.5, 2.5, 3.5 |
| Angle [°] | 0, 17, 30 | 0, 17, 30 | 0, 17, 30 |
| Sterilization | Non sterile | Non sterile | Sterile |
| Single Use | Yes | Yes | Yes |
ﺖ Flat Attachment
| Device | SUBJECT DEVICE | PRIMARY PREDICATE | REFERENCE PREDICATE |
|---|---|---|---|
| Flat AttachmentConical Platform | Flat AttachmentInternal Hex (Standard Platform)(K140440) | Device - LOCATOR® ImplantAttachment System(K083324) | |
| Noris Medical Ltd. | Noris Medical Ltd. | ZEST ANCHORS, INC. |
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Image /page/12/Picture/0 description: The image contains the logo for NORIS Medical Dental Implant Solutions. The logo consists of a red abstract shape resembling the letter 'N' on the left, followed by the text "NORIS Medical" in gray. Below "NORIS Medical" is the text "Dental Implant Solutions" in a smaller gray font. The logo is clean and modern, suggesting a company in the medical or dental field.
| SUBJECT DEVICE | PRIMARY PREDICATE | REFERENCE PREDICATE | |
|---|---|---|---|
| Device | Flat AttachmentConical Platform | Flat AttachmentInternal Hex (Standard Platform)(K140440) | Device - LOCATOR® ImplantAttachment System(K083324) |
| Noris Medical Ltd. | Noris Medical Ltd. | ZEST ANCHORS, INC. | |
| Design Description | Cylindrical shape with concaveemergence profile body.Free-rotation (non-engage) withintegrated screw portion to threaddirectly to the implant.Interface the internal connection ofthe implant cone.Attachment head to connect tooverdenture metal house withretentive elastomer cap. | Cylindrical shape with concave emergenceprofile body.Free-rotation (non-engage) with integratedscrew portion to thread directly to theimplant.Interface the internal connection of theimplant cone.Attachment head to connect to overdenturemetal house with retentive elastomer cap. | Cylindrical shape with concaveemergence profile body.Free-rotation (non-engage) withintegrated screw portion to threaddirectly to the implant.Interface the internal connection ofthe implant cone.Attachment head to connect tooverdenture metal house withretentive elastomer cap. |
| Material | Titanium alloy Ti-6Al-4V ELI | Titanium alloy Ti-6Al-4V ELI | Titanium alloy |
| Color | Gold Anodize | No Color | Partial Gold Anodize |
| Diameter | 3.87 | 3.87 | 3.87 |
| Gingival Height* [mm] | 0.5, 1, 2, 3, 4, 5 | 0.5, 1, 2, 3, 4, 5 | 1, 2, 3, 4, 5, 6 |
| Angle [°] | 0 | 0 | 0 |
| Sterilization | Non sterile | Non sterile | Sterile |
| Single Use | Yes | Yes | Yes |
- Flat attachments Gingival Height- Distance from the flat coronal surface of implants with diameters of 3.5mm,
3.75mm, and 4.2mm, measured up to 0.5mm below the metal cap of the flat attachment.
For implants with a diameter of 3.25mm, this distance is 0.86 mm below the metal cap of the flat attachment.
g. Temporary abutment
| Device | SUBJECT DEVICE | PRIMARY PREDICATE | REFERENCE PREDICATE |
|---|---|---|---|
| Non-engage Temporaryabutment/Temporary AbutmentConical Platform | Non-engage Temporary abutment/Temporary AbutmentInternal Hex (Standard Platform)(K140440) | Nobel Active Temporary AbutmentNobel Biocare N1™ TCC ConicalConnection NP (Narrow Platform)(K142260) | |
| Noris Medical Ltd. | Noris Medical Ltd. | ZEST ANCHORS, INC. | |
| Design Description | Free-rotation (non-engage).Interface the internal connection ofthe implant cone.The product includes dedicatedscrew to connect to the implant. | Free-rotation (non-engage).Interface the internal connection of theimplant cone.The product includes dedicated screw toconnect to the implant. | Free-rotation (non-engage).Interface the internal connection ofthe implant cone.The product includes dedicated screwto connect to the implant. |
| Material | Titanium alloy Ti-6Al-4V ELI | Titanium alloy Ti-6Al-4V ELI | Titanium alloy |
| Color | Gold Anodize | No Color | Gold Anodize / Partial PinkAnodize |
| Diameter | 4.3 | 4.4 | Not published |
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Image /page/13/Picture/0 description: The image contains the logo for Noris Medical. The logo consists of a red abstract shape on the left, followed by the text "NORIS Medical" in gray. Below "NORIS Medical" is the text "Dental Implant Solutions" also in gray.
| Device | SUBJECT DEVICE | PRIMARY PREDICATE | REFERENCE PREDICATE |
|---|---|---|---|
| Non-engage Temporaryabutment/Temporary AbutmentConical Platform | Non-engage Temporary abutment/Temporary AbutmentInternal Hex (Standard Platform)(K140440) | Nobel Active Temporary AbutmentNobel Biocare N1™ TCC ConicalConnection NP (Narrow Platform)(K142260) | |
| Noris Medical Ltd. | Noris Medical Ltd. | ZEST ANCHORS, INC. | |
| External Body Height*[mm] | 9.5 | 9/ 9.5 | 10 |
| Angle [°] | 0 | 0 | 0 |
| Sterilization | Non sterile | Non sterile | Sterile |
| Single Use | Yes | Yes | Yes |
- External Body Height- The height from implant platform (for 3.5,3.75 and 4.2 diameter implants)
h. Cover screw / Abutment screw
| SUBJECT DEVICE | PRIMARY PREDICATE | REFERENCE PREDICATE | |
|---|---|---|---|
| Device | Cover screw/ Abutment ScrewConical Platform | Cover screw/ Abutment Screw Internal Hex(Standard Platform)(K140440) | Cover ScrewConical Connection NP/ Multi-UnitAbutment Screw (Narrow Platform)(K142260) |
| Noris Medical Ltd. | Noris Medical Ltd. | ZEST ANCHORS, INC. | |
| Design Description | ScrewFree-rotation (non-engage) withintegrated screw portion to threaddirectly to the implant.Interface the implant upper face. | ScrewFree-rotation (non-engage) with integratedscrew portion to thread directly to theimplant.Interface the implant upper face. | ScrewFree-rotation (non-engage) withintegrated screw portion to threaddirectly to the implant.Interface the implant upper face. |
| Material | Titanium alloy Ti-6Al-4V ELI | Titanium alloy Ti-6Al-4V ELI | Titanium alloy |
| Color | Gold Anodize | Blue Anodize | Pink/Purple Anodize/ dark coating |
| Diameter | Cover screws: 3.2, 3.5 | Cover screws: 3.8 | Cover screws: 3 |
| Abutment screws: 2 | Abutment screws: 2.1 | Abutment screws: not published | |
| Length [mm] | Cover screws: 4.9 | Cover screws: 5 | Cover screws: not published |
| Abutment screws: 7.3 | Abutment screws: 8.3 | Abutment screws: not published | |
| Angle [°] | 0 | 0 | 0 |
| Sterilization | Non sterile | Non sterile | Sterile |
| Single Use | Yes | Yes | Yes |
VII. PERFORMANCE DATA
Fatigue tests per ISO 14801 were performed to determine the fatigue strength for UniCon implants, according to FDA Guidance.
The subject implant devices undergo RBM (Resorbable Blasting Media) surface treatment and color anodization within its connection for the purpose of color coding. The Prosthetic
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Image /page/14/Picture/0 description: The image is a logo for Noris Medical Dental Implant Solutions. The logo consists of a red abstract shape on the left, followed by the text "NORIS Medical" in gray. Below the text "NORIS Medical" is the text "Dental Implant Solutions" in a smaller font size and also in gray. The logo is simple and modern, and it is likely used to represent the company's brand.
device and screws undergoes Gold anodization process. Non- clinical worst-case Biocompatibility leverage was performed since the material, manufacturing, and surface treatments are identical to the material, manufacturing, and surface treatments used to manufacture dental implants cleared in K151909.
Non-clinical worst-case Reprocessing sterilization for the subject prosthetic device and screws and sterilization for subject devices Implants was leveraged since the material and design is the same as previously cleared devices in K140440.
Pyrogen limits specifications are monitored at set intervals. Test was leveraged since there is no change from previously cleared devices in K140440.The method used to make the determination that the device meets pyrogen limits specifications is based on USP <85>.
Non-clinical worst-case MRI review was performed to evaluate the metallic Noris Medical's Conical Platform Dental Implants System, UniCon, Tuff UniCon in the MRI environment using scientific rationale and published literature (e.g., Woods, Terry 0., Jana G. Delfino, and Sunder Rajan. 'Assessment of Magnetically Induced Displacement Force and Torque on Metal Alloys Used in Medical Devices." Journal of Testing and Evaluation 49.2 (2019): 783-795)., based on the entire system including all variations (all compatible implant bodied, dental abutments and, fixation screws) and material composition. Rationale addressed parameters per the FDA Guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment," including magnetically induced displacement force and torque.
VIII. CONCLUSION
Noris Medical's comparative analysis clearly demonstrates that any differences between our subject devices and predicate devices do not compromise safety or effectiveness. Modifications or improvements made to the design aim to enhance performance and patient outcomes without deviating from the fundamental characteristics of predicate devices.
Thus, the subject devices have been demonstrated to be substantially equivalent to the predicate device.
§ 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.