(416 days)
No
The document describes a physical dental implant system and its components, with no mention of software, algorithms, or data processing that would indicate the use of AI or ML. The performance studies focus on mechanical, material, and biological compatibility testing.
Yes.
The device is indicated for "functional and esthetic oral rehabilitation" and to "restore chewing function," which are therapeutic purposes.
No
The device, NUVENTUS NV.C™ Dental Implants, is an endosseous dental implant system used for oral rehabilitation, which is a therapeutic purpose, not a diagnostic one.
No
The device description clearly states that the device is a dental implant system, which includes physical components like implants and cover screws made of Ti-6Al-4V alloy. The submission details non-clinical testing related to these physical components (e.g., mechanical testing, sterilization, biocompatibility).
Based on the provided text, the NUVENTUS NV.C™ Dental Implant System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for "functional and esthetic oral rehabilitation of the upper or lower jaw of edentulous or partially edentulous patients." This describes a surgical implant used to restore function and appearance, not a device used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or compatibility.
- Device Description: The description details the physical characteristics of the dental implants and cover screws, their materials, and how they interface with prosthetic components. This aligns with the description of a medical device intended for implantation, not an IVD.
- Performance Studies: The performance studies described are focused on the mechanical properties, biocompatibility, sterilization, and surface characteristics of the implants, as well as their compatibility with prosthetic components. These are typical tests for implantable medical devices, not IVDs which would involve studies related to analytical and clinical performance using biological samples.
- Lack of IVD Indicators: There is no mention of analyzing biological samples (blood, tissue, etc.), detecting analytes, or providing diagnostic information.
Therefore, the NUVENTUS NV.C™ Dental Implant System is a medical device intended for surgical implantation, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
NUVENTUS NV.C™ Dental Implants are indicated for the functional and esthetic oral rehabilitation of the upper or lower jaw of edentulous or partially edentulous patients. NUVENTUS NV.C™ dental implants may be used for immediate, early or delayed implantation following the extraction or loss of natural teeth. The implants can be placed with immediate loading for single-tooth or multiple teeth restorations when good primary stability is achieved and with appropriate occlusal loading to restore chewing function. NV.C™ Dental Implants are compatible for use with the following prosthetic interfaces.
| Implant System Prosthetic Compatibility | Platform Size/Designation |
|---|---|
| Nobel Biocare Internal Conical Connection (CC) | NP CC |
| RP CC |
Product codes
DZE, NHA
Device Description
The purpose of this submission is to obtain marketing clearance for NUVENTUS NV.C™ Dental Implant System endosseous dental implants and cover screws. The dental implants are intended to interface with Internal Conical Connection (CC) prosthetic components from Nobel Biocare.
A summary of the subject device implant and the associated compatible OEM prosthetic connection is provided in the table Summary of Subject Device Implant Designs.
| Subject Device Implant Description | Platform Designation | Length (mm)* | OEM Prosthetic Compatibility (K071370, K161435, K161416) | ||||
|---|---|---|---|---|---|---|---|
| Implant, NV.C, Platform NP, Ø3.5 mm | NP | 8.5 | 10 | 11.5 | 13 | 15 | Nobel Biocare Internal Conical, NP Platform |
| Implant, NV.C, Platform NP, Ø4.3 mm | NP | 8.5 | 10 | 11.5 | 13 | 15 | Nobel Biocare Internal Conical, NP Platform |
| Implant, NV.C, Platform RP, Ø5.0 mm | RP | 8.5 | 10 | 11.5 | 13 | 15 | Nobel Biocare Internal Conical, RP Platform |
- Labeled Length - actual length of the implant is 0.5 mm less than the labeled length.
The subject device dental implants have a conical abutment seating surface on the interior of the implants and internal threads so that prosthetic components may be fastened to the implant. The implant lines have two (2) abutment interface connections with internal geometric features to allow for rotational resistance of the mating abutment. All subject device implants are manufactured from Ti-6Al-4V alloy conforming to ASTM F136.
The external surface of all subject device implants is threaded, and the implant body tapers at the apical end. which includes two (2) cutting flutes. At the coronal end. the Ø4.3mm and Ø5.0mm (body diameter) subject device implants have two (2) fluted features on the body of the implant spaced 180° apart. Each fluted feature has horizontal grooves spaced vertically within the flute surface. The number of grooves within each flute ranges from 3 to 5 and the actual number is a function of the implant length. The Ø3.5mm (body diameter) subject device implants do not have fluted features. The endosseous surface of all subject implants is textured by blasting with resorbable media.
The subject device implants are compatible with prosthetic components that interface with Nobel Biocare Internal Connection implants. The subject device cover screws are manufactured from Ti-6A1-4V alloy conforming to ASTM F136 and are anodized to identify the prosthetic platform (NP and RP).
The compatible Nobel Biocare Internal Conical Connection prosthetic components (NP and RP platforms) include cover screws, healing abutments, temporary abutments esthetic abutments, straight multi-unit abutment, and angled multi-unit abutments.
All subject device implants and cover screws are individually packaged and are provided sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper or lower jaw
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical data submitted to demonstrate substantial equivalence included:
- engineering analysis demonstrates that the subject device implants are compatible with Nobel Biocare Internal Connection prosthetic components (NP and RP platforms);
- non-clinical worst-case MRI review to evaluate the subject device components in the MR environment using scientific rationale and published literature (T.O. Woods, J.G. Delfino, and S. Rajan, "Assessment of Magnetically Induced Displacement Force and Torque on Metal Alloys Used in Medical Devices," Journal of Testing and Evaluation, Volume 49 (2): 783–795), based on the entire system including all variations (implant bodies, prosthetic components, and fixation screws) and material composition, and the 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;
- sterilization testing conducted to validate the gamma irradiation sterilization process to a sterility assurance level of 10-6 by selecting and substantiating a 25 kGy dose using method VDmax25, according to ISO 11137-1 and ISO 11137-2; bacterial endotoxin testing including Limulus amebocyte lysate (LAL) test according to ANSI/AAMI ST72 to demonstrate that all sterile product meets a limit of
§ 872.3640 Endosseous dental implant.
(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".
November 15, 2024
Infinitum Eta Ltd. % Valerie Defiesta-Ng, Executive Director of Regulatory Affairs Veranex, Inc. 5420 Wade Park Blvd. Suite 204 Raleigh, NC 27607 USA
Re: K233081
Trade/Device Name: NUVENTUS NV.CTM Dental Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: October 22, 2024 Received: October 22, 2024
Dear Valerie Defiesta-Ng:
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.
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"
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(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 OS 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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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.
For comprehensive regulatory information about mediation-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).
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Sincerely,
Sherrill Lathrop Blitzer
for Andrew 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) K233081
Device Name
NUVENTUS NV.CTM Dental Implant System
Indications for Use (Describe)
NUVENTUS NV.C™ Dental Implants are indicated for the functional and esthetic oral rehabilitation of the upper or lower jaw of edentulous or partially edentulous patients. NUVENTUS NV.C™ dental implants may be used for immediate, early or delayed implantation following the extraction or loss of natural teeth. The implants can be placed with immediate loading for single-tooth or multiple teeth restorations when good primary stability is achieved and with appropriate occlusal loading to restore chewing function. NV.C™ Dental Implants are compatible for use with the following prosthetic interfaces.
| Implant System Prosthetic Compatibility | Platform Size/Designation |
|---|---|
| Nobel Biocare Internal Conical Connection (CC) | NP CC |
| RP CC |
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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510(k)
Summary K233081 NUVENTUS NV.CTM Dental Implant System Infinitum Eta Ltd.
November 15, 2024
ADMINISTRATIVE INFORMATION
| Manufacturer Name | Infinitum Eta Ltd. |
|---|---|
| HaTnufa St 6 | |
| Petah Tikva, 4951024, Israel | |
| Telephone: +972-54-5559399 | |
| Official Contact | Kobi Shakarchi, Chief Executive Officer |
| Representative/Consultant | Valerie Defiesta-Ng |
| Veranex, Inc. | |
| 5420 Wade Park Blvd., Suite 204 | |
| Raleigh, NC 27607 USA | |
| Email: valerie.defiesta-ng@veranex.com |
DEVICE NAME AND CLASSIFICATION
| Trade/Device Name | NUVENTUS NV.CTM Dental Implant System |
|---|---|
| Common Name | Endosseous dental Implant |
| Regulation Number | 21 CFR 872.3640 |
| Regulation Name | Endosseous Dental Implant |
| Regulatory Class | Class II |
| Product Code | DZE |
| Secondary Product Code | NHA |
| Classification Panel | Dental |
| Reviewing Office | Office of Health Technology 1 |
| (Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices) | |
| Reviewing Division | Division of Dental and ENT Devices |
PREDICATE DEVICE INFORMATION
Primary Predicate Device K142260, NobelActive®, Nobel Biocare AB
Reference Devices K163349, MIS V3 Conical Connection Dental Implant System, MIS Implants Technologies Ltd.; K181850, Inversa Implants, Southern Implants (Pty) Ltd.; K071370, NobelActive Internal Connection Implant, Nobel Biocare AB; K161435, Temporary Snap Abutment, Nobel Biocare AB; K161416, Multi-unit Abutment Plus, Nobel Biocare AB
5
INDICATIONS FOR USE STATEMENT
NUVENTUS NV.C™ Dental Implants are indicated for the functional and esthetic oral rehabilitation of the upper or lower jaw of edentulous or partially edentulous patients. NUVENTUS NV.C™ dental implants may be used for immediate, early or delayed implantation following the extraction or loss of natural teeth. The implants can be placed with immediate loading for single-tooth or multiple teeth restorations when good primary stability is achieved and with appropriate occlusal loading to restore chewing function. NUVENTUS NV.CTM Dental Implants are compatible for use with the following prosthetic interfaces.
| Implant System Prosthetic Compatibility | Platform Size/Designation |
|---|---|
| Nobel Biocare Internal Conical Connection (CC) | NP CC |
| RP CC |
SUBJECT DEVICE DESCRIPTION
The purpose of this submission is to obtain marketing clearance for NUVENTUS NV.C™ Dental Implant System endosseous dental implants and cover screws. The dental implants are intended to interface with Internal Conical Connection (CC) prosthetic components from Nobel Biocare.
A summary of the subject device implant and the associated compatible OEM prosthetic connection is provided in the table Summary of Subject Device Implant Designs.
| Subject Device Implant
Description | Platform
Designation | Length (mm)* | | | | | OEM Prosthetic Compatibility
(K071370, K161435, K161416) |
|---------------------------------------|-------------------------|--------------|----|------|----|----|-------------------------------------------------------------|
| Implant, NV.C, Platform NP, Ø3.5 mm | NP | 8.5 | 10 | 11.5 | 13 | 15 | Nobel Biocare Internal Conical, NP Platform |
| Implant, NV.C, Platform NP, Ø4.3 mm | NP | 8.5 | 10 | 11.5 | 13 | 15 | Nobel Biocare Internal Conical, NP Platform |
| Implant, NV.C, Platform RP, Ø5.0 mm | RP | 8.5 | 10 | 11.5 | 13 | 15 | Nobel Biocare Internal Conical, RP Platform |
Summary of Subject Device Implant Designs
- Labeled Length - actual length of the implant is 0.5 mm less than the labeled length.
The subject device dental implants have a conical abutment seating surface on the interior of the implants and internal threads so that prosthetic components may be fastened to the implant. The implant lines have two (2) abutment interface connections with internal geometric features to allow for rotational resistance of the mating abutment. All subject device implants are manufactured from Ti-6Al-4V alloy conforming to ASTM F136.
The external surface of all subject device implants is threaded, and the implant body tapers at the apical end. which includes two (2) cutting flutes. At the coronal end. the Ø4.3mm and Ø5.0mm (body diameter) subject device implants have two (2) fluted features on the body of the implant spaced 180° apart. Each fluted feature has horizontal grooves spaced vertically within the flute surface. The number of grooves within each flute ranges from 3 to 5 and the actual number is a function of the implant length. The Ø3.5mm (body diameter) subject device implants do not have fluted features. The endosseous surface of all subject implants is textured by blasting with resorbable media
The subject device implants are compatible with prosthetic components that interface with Nobel Biocare Internal Connection implants. The subject device cover screws are manufactured from Ti-6A1-4V alloy conforming to ASTM F136 and are anodized to identify the prosthetic platform (NP and RP).
6
The compatible Nobel Biocare Internal Conical Connection prosthetic components (NP and RP platforms) include cover screws, healing abutments, temporary abutments esthetic abutments, straight multi-unit abutment, and angled multi-unit abutments.
All subject device implants and cover screws are individually packaged and are provided sterile.
PERFORMANCE DATA
Non-clinical data submitted to demonstrate substantial equivalence included:
- engineering analysis demonstrates that the subject device implants are compatible with Nobel ● Biocare Internal Connection prosthetic components (NP and RP platforms);
- . non-clinical worst-case MRI review to evaluate the subject device components in the MR environment using scientific rationale and published literature (T.O. Woods, J.G. Delfino, and S. Rajan, "Assessment of Magnetically Induced Displacement Force and Torque on Metal Alloys Used in Medical Devices," Journal of Testing and Evaluation, Volume 49 (2): 783–795), based on the entire system including all variations (implant bodies, prosthetic components, and fixation screws) and material composition, and the 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;
- . sterilization testing conducted to validate the gamma irradiation sterilization process to a sterility assurance level of 106 by selecting and substantiating a 25 kGy dose using method VDma25, according to ISO 11137-1 and ISO 11137-2; bacterial endotoxin testing including Limulus amebocyte lysate (LAL) test according to ANSI/AAMI ST72 to demonstrate that all sterile product meets a limit of