NUVENTUS NV.C Dental Implant System
Device Facts
| Record ID | K233081 |
|---|---|
| Device Name | NUVENTUS NV.C Dental Implant System |
| Applicant | Infinitum Eta, Ltd. |
| Product Code | DZE · Dental |
| Decision Date | Nov 15, 2024 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 872.3640 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Intended 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.
Device Story
Endosseous dental implant system; includes implants and cover screws. Implants feature threaded bodies with apical taper; coronal flutes on specific diameters (4.3mm, 5.0mm) for bone engagement; internal conical connection for prosthetic interface. Manufactured from Ti-6Al-4V alloy (ASTM F136); surface textured via blasting with resorbable media. Used by dental clinicians in clinical settings for oral rehabilitation. Implants provide structural foundation for prosthetic components (crowns, bridges, overdentures). Output is physical support for dental restorations; aids in restoring chewing function and esthetics. Compatible with Nobel Biocare Internal Conical Connection prosthetic components.
Clinical Evidence
No clinical trials performed for subject device. Substantial equivalence supported by non-clinical bench testing (mechanical, sterilization, biocompatibility, surface analysis) and literature review of predicate/reference devices. Literature (10 studies) confirms safety/effectiveness of similar conical connection and body-shift designs, showing high survival rates (100%) and stable marginal bone levels over 1-5 year follow-ups.
Technological Characteristics
Material: Ti-6Al-4V alloy (ASTM F136). Design: Threaded endosseous implant, apical taper, internal conical connection. Surface: Grit-blasted with resorbable media. Sterilization: Gamma irradiation (ISO 11137-1/2). Dimensions: 3.5-5.0mm diameter, 8.0-15mm length. Connectivity: Mechanical interface with OEM prosthetic components.
Indications for Use
Indicated for functional and esthetic oral rehabilitation of upper or lower jaw in edentulous or partially edentulous patients. Suitable for immediate, early, or delayed implantation post-tooth extraction/loss. Supports immediate loading for single or multiple tooth restorations given adequate primary stability and occlusal loading.
Regulatory Classification
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.
Special Controls
*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.
Predicate Devices
- NobelActive® (K142260)
Reference Devices
- MIS V3 Conical Connection Dental Implant System (K163349)
- Inversa Implants (K181850)
- NobelActive Internal Connection Implant (K071370)
- Temporary Snap Abutment (K161435)
- Multi-unit Abutment Plus (K161416)
Related Devices
- K242217 — Surcam Dental Implant System · Surcam Medical Devices and Developments, Ltd. · Jan 29, 2025
- K193401 — Altatec GmbH CAMLOG/CONELOG PROGRESSIVE-LINE Implants · Altatec GmbH · Sep 29, 2020
- K210886 — MIS Lance+ Conical Connection Dental Implant System · Dentsply Sirona · Jun 17, 2021
- K991822 — ALLFIT IMPLANT SYSTEM, SHORT NECK, MODEL STI RT LENGTH, ALLFIT IMPLANT SYSTEM, LONG NECK, MODEL STI RT LN LENGTH · Dr. Ihde Dental AG Switzerland · Aug 15, 2001
- K180598 — UNIQA Dental Implants System · Uniqa Dental, Ltd. · Aug 8, 2018
Submission Summary (Full Text)
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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<br>(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
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### 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<br>Description | Platform<br>Designation | Length (mm)* | | | | | OEM Prosthetic Compatibility<br>(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).
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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 < 20 EU/device: and shelf life testing of samples after accelerated aging equivalent to five (5) years of real time aging according to ASTM F1980, with testing of the packaging sterile barrier;
- biocompatibility testing according to ISO 10993-5 (cvtotoxicity) to demonstrate that the final . finished subject device components (implants and cover screws) will be substantially equivalently biocompatible for their intended use;
- Surface treatment analysis by performing SEM and EDS testing conducted according to "Root-. form Endosseous Dental Implants and Endosseous Dental Abutments - Class II Special Controls Guidance Document for Industry and FDA Staff" and FDA Guidance Document "Recommended Content and Format of Non-Clinical Bench Performance Testing Information in Premarket Submissions" to demonstrate the subject devices' surface does not contain residues from the production process;
- mechanical testing conducted according to ISO 14801:2016 and "Root-form Endosseous Dental Implants and Endosseous Dental Abutments - Class II Special Controls Guidance Document for Industry and FDA Staff" to demonstrate the performance of the subject device implants and compatible OEM prosthetic components in comparison to primary predicate K142260;
- . comparative surface area analysis considering the worst-case scenario for clinical placement (smallest implant and largest osteotomy per the approved drilling protocols), including total surface area, total surface area with simulated 3 mm of bone loss and, surface area of initial bone-to-implant contact to demonstrate substantial equivalence to the reference devices K163349 and K181850, and
- pullout testing comparing subject device implant to a reference device of similar size and ● surface treatment (K163349) considering the clinical worst-case scenario for clinical placement (smallest implant and largest osteotomy per the approved drilling protocols) to demonstrate substantial equivalence to the reference device.
Clinical testing literature data used to demonstrate substantial equivalence included:
- . review of clinical literature data for primary predicate K142260 and reference predicate K163349 to demonstrate that gaps or distances between the implant collars and osteotomy bone, did not result in incomplete integration, bone recession, or loss and that the implant collar design and bone-to-implant area of the predicate and reference devices have shown consistent clinical safety and effectiveness,
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with no negative outcome. In case of reference predicate K181850 the gap between implant collar and osteotomy bone did not result in incomplete integration, when adequately filled with bone grafting material. The table below shows the used literature.
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## Clinical Testing Literature Table
| Number | Citation | Subject<br>Device<br>Design<br>Feature | Implant | Study<br>Design | Treatment<br>concept | Clinical outcomes - Bone level<br>changes | Relevance to NUVENTUS NV.C |
|--------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------|----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Gultekin BA, Gultekin<br>P. Leblebicioglu B.<br>Basegmez C, Yalcin S.<br>Clinical evaluation of<br>marginal bone loss and<br>stability in two types of<br>submerged dental<br>implants. Int J Oral<br>Maxillofac Implants.<br>2013 May-<br>Jun;28(3):815-23 | Internal<br>conical<br>connection | K142260<br>NobelActive®<br>Nobel Biocare<br>AB.<br>Nobel Replace<br>Tapered (Nobel<br>Biocare AB). | Prospective<br>Clinical Trial | Healed site<br>(3 months) | The cumulative implant<br>survival rate was 100%. At the<br>second-stage surgery, bone<br>levels were similar between<br>groups. One year after loading,<br>mean crestal bone loss was 0.35<br>± 0.13 mm for NobelActive<br>implants and 0.83 ±0.16 mm<br>for NobelReplace implants, a<br>significant difference. | Both implant systems had the same survival rates.<br>NobelActive implants with a built-in platform switch and conical<br>connection with back-tapered collar design achieved higher primary<br>stability at insertion and less bone resorption after 15 months. Conical<br>connection of NUVENTUS NV.C is compatible to NobelActive<br>implants.<br>Relevant design feature for subject device: The conical connection of<br>NUVENTUS NV.CTM is compatible to NobelActive® implants. This<br>article provides performance information based on the long-term data<br>for three-dimensional marginal bone level, implant stability, and peri-<br>implant health that is considered to be relevant to the subject device. |
| 2 | Kolinski ML, Cherry JE,<br>McAllister BS, Parrish<br>KD, Pumphrey DW,<br>Schroering RL.<br>Evaluation of a variable-<br>thread tapered implant in<br>extraction sites with<br>immediate<br>temporization: a 3-year<br>multicenter clinical<br>study. J Periodontol.<br>2014 Mar;85(3):386-94. | Internal<br>conical<br>connection | K142260<br>NobelActive®<br>Nobel Biocare<br>AB | Prospective<br>Multicenter<br>Clinical<br>Study | Fresh<br>extraction<br>sockets | Thirty-five implants were<br>evaluated at both implant<br>insertion and 3-year follow-up.<br>There was a slight decrease in<br>mean bone level from -0.68 mm<br>at implant insertion to -0.93 mm<br>at the 6-month recall and then<br>an increase of bone to -0.53 mm<br>from the reference point at the<br>2-year follow-up (an average<br>increase of 0.15 mm from<br>implant insertion). | The results showed stable bone and soft tissue levels around this<br>implant after 3 years in function, indicating that the implant can be<br>used safely and effectively under the demanding conditions of<br>immediate loading on implants placed in extraction sockets while also<br>providing a high level of patient satisfaction. All implants were<br>reported stable at the 6-month, 1-year, 2-year, and 3-year follow-ups.<br>Relevant design feature for subject device: The conical connection of<br>NUVENTUS NV.CTM is compatible to NobelActive® implants. This<br>article provides performance information based on the long-term data<br>for bone remodeling, survival rate, and soft tissue health that is<br>considered to be relevant to the subject device. |
| 3 | Pozzi A, Agliardi E,<br>Tallarico M, Barlattani<br>A. Clinical and<br>radiological outcomes of<br>two implants with<br>different prosthetic<br>interfaces and neck<br>configurations:<br>randomized, controlled,<br>split-mouth clinical trial.<br>Clin Implant Dent Relat<br>Res. 2014 Feb;16(1):96-<br>106. | Internal<br>conical<br>connection | K142260<br>NobelActive®<br>Nobel Biocare<br>AB.<br>Nobel Speedy<br>Groovy, Nobel<br>Biocare AB. | Randomized<br>Controlled<br>Trial | Healed site<br>(6 months) | No implants and prosthesis<br>failed. Survival rate was 100%.<br>Marginal bone changes were<br>statistically significantly<br>different with better results for<br>the internal conical connection:<br>mean marginal bone loss (mm)<br>(SD): 0.37 (0.23) for Nobel<br>Active, vs 0.95 (0.56) for Nobel<br>Speedy Groovy from baseline to<br>16 weeks (unloaded period). | Both implant designs (NobelActive K142260 and NobelSpeedy<br>Groovy K160119 investigated provided successful results; however,<br>the MBL was statistically significantly lower in the back-tapered neck<br>configuration with conical connection of K142260 - equivalent internal<br>conical connection, as NUVENTUS NV.C.<br>Relevant design feature for subject device: The conical connection of<br>NUVENTUS NV.CTM is compatible to NobelActive® implants. This<br>article provides performance information based on the long-term data<br>comparing clinical and radiological outcomes that is considered to be<br>relevant to the subject device. |
| 4 | Li Manni L. Lecloux G.<br>Rompen E, Aouini W,<br>Shapira L, Lambert F.<br>Clinical and radiographic<br>assessment of circular<br>versus triangular<br>crosssection neck<br>Implants in the posterior<br>maxilla: A 1-year<br>randomized controlled<br>trial. Clin Oral Implants<br>Res. 2020<br>Sep;31(9):814-824. | Triangular<br>neck<br>design | K163349<br>MIS V3<br>Conical<br>Connection<br>Dental Implant<br>System<br>MIS Implants<br>Technologies<br>Ltd.<br>MIS C1 Dental<br>Implant<br>System. | Randomized<br>Controlled<br>Trial | Healed site<br>(12 weeks) | No implant loss occurred within<br>the follow-up period. The mean<br>± SD peri-implant proximal<br>bone loss 1-year after loading<br>was 0.22 ± 0.30 mm for<br>triangular and 0.42 ± 0.67 mm<br>for circular implants necks<br>(p=0.25). | Circular and triangular (K163349) cross-section neck implants in the<br>posterior maxilla were similar with respect to peri-implant bone<br>changes. The implant neck design did not impact the pink aesthetic<br>score and the patient satisfaction.<br>Relevant design feature for subject device: Like the MIS V3, the<br>NUVENTUS NV.CTM implant is designed with coronal flutes. This<br>article provides performance information based on one-year data<br>comparing peri-implant bone changes of circular versus triangular<br>cross-section neck implants that is considered to be relevant to the<br>subject device. |
| | | Subject<br>Device | | | | | |
| | | Design | | Study | Treatment | Clinical outcomes - Bone level | |
| Number | Citation | Feature | Implant | Design | concept | changes | Relevance to NUVENTUS NV.C |
| 5 | Hurtgen A, Seidel L,<br>Manni LL, Liegeois L,<br>Lecloux G, Lambert F.<br>Clinical and radiographic<br>assessment of circular<br>versus triangular cross-<br>section neck implants in<br>the posterior maxilla:<br>Five-year follow-up of a<br>randomized controlled<br>trial. Clin Oral Implants<br>Res. 2023 Jul;34(7):698-<br>706. | Triangular<br>neck<br>design | K163349<br>MIS V3<br>Conical<br>Connection<br>Dental Implant<br>System<br>MIS Implants<br>Technologies<br>Ltd.<br>MIS<br>C1 Dental<br>Implant<br>System. | Randomized<br>Controlled<br>Trial | Healed site<br>placement<br>(12 weeks) | No implant loss occurred during<br>the 5-year follow up period. The<br>mean ± SD proximal bone<br>remodeling after 5 years<br>reached 0.38 ± 0.39 mm for the<br>circular design and 0.29 ± 0.58<br>mm for the triangular design (p<br>= .49). | The 5-year evaluation of the triangular neck implants showed similar<br>results to the circular neck implants.<br>Relevant design feature for subject device: The 5year clinical data for<br>the predicate with initial gap between implant collar and osteotomy<br>bone showed low rates of peri-implant bone loss and occurrence of<br>periodontitis. This article provides relevant performance information<br>based on assessing the peri-implant bone stability and the peri-implant<br>soft tissue conditions over 5-years and is considered to be relevant to<br>the subject device. |
| 6 | Tokuc B, Kan B. The<br>effect of triangular cross-<br>section neck design on<br>crestal bone stability in<br>the anterior mandible: A<br>randomized, controlled,<br>splitmouth clinical trial.<br>Clin Oral Implants Res.<br>2021 Oct;32(10):1241-<br>1250. | Triangular<br>neck<br>design<br>(TN) | K163349<br>MIS V3<br>Conical<br>Connection<br>Dental Implant<br>System<br>MIS Implants<br>Technologies<br>Ltd. MIS C1<br>(circular neck,<br>RN) Dental<br>Implant<br>System. | Randomized<br>Controlled<br>Trial | Healed site<br>(3 months) | No implant loss was observed<br>during the follow-up period.<br>The mean ± SD proximal<br>crestal bone loss one year after<br>loading was 0.58 ± 0.36 mm for<br>TN and 0.91 ±0.59 mm for RN<br>(p < 0.01). | The presentation of stable peri-implant soft tissue and crestal bone<br>levels in both circular and triangle (K163349) neck groups.<br>Relevant design feature for subject device: This article provides<br>performance information comparing crestal bone loss and buccal bone<br>thickness around a triangular cross-section neck to a round neck design<br>over a one-year period of follow-up. Stable peri-implant soft tissue and<br>crestal bone levels were observed for both groups, which are<br>considered to be relevant to the subject device. |
| 7 | Chu SJ, Östman PO,<br>Nicolopoulos C.<br>Yuvanoglu P, Chow J,<br>Nevins M, Tarnow DP.<br>Prospective Multicenter<br>Clinical Cohort Study of<br>a Novel Macro Hybrid<br>Implant in Maxillary<br>Anterior Postextraction<br>Sockets: 1-Year Results.<br>Int J Periodontics<br>Restorative Dent.<br>2018;38(Suppl):s17-s27. | Narrow<br>coronal<br>segment<br>of the<br>implant | K181850<br>Inversa<br>Implants,<br>Southern<br>Implant (Pty),<br>Ltd | Prospective<br>Multicenter<br>Cohort Study | Fresh<br>extraction<br>sockets | No implants failed during an<br>average healing period of one<br>year. Marginal bone level<br>changes: A tooth to-implant<br>interdental bone crest distance<br>and dimension of 2.3 to 2.6 mm<br>was reached; it was also<br>sustained at the 1-year follow-<br>up. No marginal bone loss was<br>evaluated, as bone graft was<br>used. | As the Inversa implants have an even larger gap between implant collar<br>and bone, they can be considered as the clinical worst-case.<br>Predicate K181850 implants were considered to be safe and effective in<br>this study when the gap was filled with bone grafting material.<br>Relevant design feature for subject device: As the Inversa implants<br>have an even larger and circumferential gap between implant collar and<br>bone, they can be considered as the clinical worst-case. Predicate<br>This article provides relevant performance information, based on one-<br>year data for a macro hybrid implant placed into maxillary anterior post<br>extraction sockets, that is considered to be a clinical worst-case to the<br>subject device. |
| 8 | Chu SJ. Inverted body-<br>shift concept in<br>macroimplant design to<br>enhance biologic and<br>esthetic outcomes: A<br>clinical report. J Prosthet<br>Dent. 2021<br>Dec;126(6):720-726. | Narrow<br>coronal<br>segment<br>of the<br>implant | K181850<br>Inversa<br>Implants,<br>Southern<br>Implant (Pty),<br>Ltd | Clinical<br>report | Fresh<br>extraction<br>sockets | At 6 months post surgery, a<br>tooth to-implant distance at the<br>distal aspect of the central<br>incisor implant between the<br>central and lateral incisors was<br>1.8 mm. No measurements of<br>marginal bone loss as bone<br>grafting was performed. | Reduction of the load on the buccal bone, as our selected predicate<br>devices prove the benefit of such designs regarding clinical long-term<br>performance and crestal bone maintenance.<br>Relevant design feature for subject device: As the Inversa implants<br>have an even larger and circumferential gap between implant collar and<br>bone, they can be considered as the clinical worst-case. Predicate<br>Inversa implants showed good clinical performance and crestal bone<br>maintenance during the study when the gap was filled with bone<br>grafting material. This article provides relevant performance<br>information based on the data, which is considered to be a clinical<br>worst-case to the subject device. |
| | | Subject<br>Device | | | | | |
| | | Design | | Study | Treatment | Clinical outcomes - Bone level | |
| Number | Citation | Feature | Implant | Design | concept | changes | Relevance to NUVENTUS NV.C |
| 9 | Gluckman H, Pontes CC,<br>Chu S. Immediate Tooth<br>Replacement in the<br>Esthetic Zone with the<br>Socket Shield Technique<br>and a Novel Body-Shift<br>Implant: A Pilot Study<br>with Up to 3 Years of<br>Follow-up. Int J<br>Periodontics Restorative<br>Dent. 2023 Oct<br>24;(7):s107-s117. | Narrow<br>coronal<br>segment<br>of the<br>implant | K181850<br>Inversa<br>Implants,<br>Southern<br>Implant (Pty),<br>Ltd | Pilot study | Fresh<br>extraction<br>sockets | Patients were followed up for<br>12 to 39 months (mean<br>$18.1\pm8.2$ months). The survival<br>rate was 100%. Mean<br>interproximal marginal bone<br>loss was $-0.4\pm0.5$ mm | As the Inversa implants have an even larger gap between implant collar<br>and bone, they can be considered as the clinical worst-case. Predicate<br>K181850 implants were considered to be safe and effective in this<br>study.<br>Relevant design feature for subject device: As the predicate Inversa<br>implants have an even larger and circumferential gap between implant<br>collar and bone, they can be considered as the clinical worst-case. The<br>predicate device showed good clinical performance and crestal bone<br>maintenance during the study when the gap was filled with bone<br>grafting material. This article provides relevant performance<br>information for marginal bone loss for the predicate device, which is<br>considered to be a clinical worst-case to the subject device. |
| 10 | O'Hooley, Dominic<br>Brenden, Costa<br>Nicolopoulos, Mark<br>Worthing, Petros<br>Yuvanoglu, Fotis Melas,<br>and Peter Fairbairn.<br>"Outcomes of a One<br>Year, Retrospective<br>Single-Arm Cohort<br>Study Using both a<br>Novel Body-Shift<br>Implant Design with a<br>Novel Alloplastic<br>Particulate Grafting<br>Material in Immediate<br>Extraction Sockets."<br>(2023) | Narrow<br>coronal<br>segment<br>of the<br>implant | K181850<br>Inversa<br>Implants,<br>Southern<br>Implant (Pty),<br>Ltd | Retrospective<br>Single-Arm<br>Cohort Study | Fresh<br>extraction<br>sockets | In this study, only the new<br>buccal bone and the PES of the<br>soft tissue are measured. No<br>measurements of marginal bone<br>loss as bone grafting was<br>performed. | The relatively narrow coronal portion of the Inversa implant along with<br>the use of bone grafting material appears to have improved bone<br>regeneration in the critical aesthetic coronal zone for enhanced tissue<br>stability. As the Inversa implants have an even larger gap between<br>implant collar and bone, they can be considered as the clinical worst-case. Predicate K181850 implants were considered to be safe and<br>effective in this study.<br>Relevant design feature for subject device: As the Inversa implants<br>have an even larger and circumferential gap between implant collar and<br>bone, they can be considered as the clinical worst-case. Predicate<br>Inversa implants were considered by the investigators to be safe and<br>effective in this study, as the predicate devices showed good clinical<br>performance and crestal bone maintenance during the study. This<br>article provides relevant performance information for stability of the<br>predicate device while using bone augmentation material placed in the<br>circumferential jumping gaps of the extraction sockets. |
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### EQUIVALENCE TO MARKETED DEVICES
The subject device is substantially equivalent in indications and design principles to the primary predicate device and the reference devices listed above. Provided at the end of this summary are tables comparing the Indications for Use Statements and the technological characteristics of the subject device, the primary predicate device, and the reference devices.
The primary predicate device K142260 is in support of substantial equivalence for the overall implant design, range of implant lengths, and material. The primary predicate device K142260 is in support of substantial equivalence specifically regarding the implant diameters and their associated indications for use, and the prosthetic connection configuration for the NUVENTUS NV.C™ subject devices.
The reference device K163349 is in support of substantial equivalence specifically with regard to the external implant macro geometry, the material, and the external surface modification. The reference device K181850 is in support of substantial equivalence specifically with regard to coronal thread engagement with the prepared osteotomy.
The Indications for Use Statement (IFUS) for the subject device includes language concerning placement in the upper or lower jaw, placement into immediate function, and support for single unit and multiple unit restorations. This language conveys the same indications as is stated in the IFUS in K142260. K163349. K181850 and K071370. Slight differences in the language of the subject and predicate Indications for Use Statements do not affect the intended use of the subject devices.
### Subject Device Dental Implants and Cover Screws
The external features of the subject device implants have similar designs compared to the primary predicate device implants cleared in K142260. Both the subject and primary predicate devices are externally threaded endosseous dental implants made from similar materials. The subject device implant body diameters range from 3.5 mm to
5.0 mm, which is within the range of implant diameters cleared in K142260. The subject device implant lengths range from 8 mm to 15 mm, which is within the range of the implant lengths cleared in K142260.
The subject device implants have internal conical abutment connections of equivalent sizes and design as compared to the implants cleared in K142260. The subject device implants with the NP prosthetic platform have an outer diameter of 3.5 mm or greater, which is equivalent to the outer diameter of the reference devices (NP 3.5 Conical Connection) in K142260.
The subject devices are provided sterile by subjecting the packaged product to gamma radiation, which is equivalent to the method used to sterilize the reference devices cleared in K163349.
The subject device implants have external surface geometry roughened by grit blasting in surface that is similar to that of the reference device implants cleared in K163349. The subject device implants and cover screws are manufactured from the same titanium alloy (Ti-6Al-4V, ASTM F136) as those cleared in K163349. The subject device cover screws are colored through a process of titanium anodization, which is equivalent to the process utilized to add color to reference prosthetic components cleared in K163349. Additionally, substantial equivalence with regard to biocompatibility is supported by biocompatibility testing per ISO 10993.
The 4.3 mm and 5.0 mm diameter subject device implants have external surface modifications in which flutes are cut into the coronal end of the implant. This feature is similar to features found on
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implants cleared in K163349 where the outer diameter of the implant (and, therefore, engagement with the bone) is reduced compared with the fully threaded section. The coronal features of the subject device implants engage the bone of the osteotomy to a greater extent compared with the bone engagement of implants cleared in K181850. The reference implants in K181850 have little or no contact with the bone in the coronal region when the implant is placed to its full seating depth. Additionally, substantial equivalence with regards to surface area and bone to implant contact is supported by comparative surface area analysis and pullout testing.
## CONCLUSION
The subject device, the primary predicate device, and the reference devices have the same intended use, encompass the same range of physical dimensions, have similar technological characteristics, are made of the same or similar materials, and are sterilized using similar methods. The data included in this submission demonstrate substantial equivalence to the predicate devices listed above.
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# Implant and Cover Screw Table of Substantial Equivalence
| | Subject Device | Primary Predicate Device | Reference Device | Reference Device | Substantial<br>Equivalence | | | | |
|----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|
| | K233081<br>Infinitum Eta Ltd.<br>NUVENTUS NV.CTM Dental Implant System | K142260<br>NobelActive®<br>Nobel Biocare<br>AB | K163349<br>MIS V3 Conical Connection Dental Implant<br>System MIS Implants Technologies Ltd. | K181850<br>Inversa Implants Southern<br>Implant (Pty) Ltd. | | | | | |
| Indications for<br>Use Statement | NUVENTUS NV.CTM Dental Implants are indicated for the<br>functional and esthetic oral rehabilitation of the upper or lower<br>jaw of edentulous or partially edentulous patients. NUVENTUS<br>NV.CTM Dental Implants may be used for immediate, early or<br>late implantation following the extraction or loss of natural teeth.<br>The implants can be placed with immediate function for single-<br>tooth and/or multiple tooth restorations when good primary<br>stability is achieved and with appropriate occlusal loading to<br>restore chewing function. NUVENTUS NV.CTM Dental Implants<br>are compatible for use with the following prosthetic interfaces.<br><br>Implant System Prosthetic<br>CompatibilityPlatform<br>Size/DesignationNobel Biocare Internal Conical<br>Connection (CC)NP CC<br>RP CC | | | | | NobelActive® implants are endosseous implants intended to<br>be surgically placed in the upper or lower jaw bone for<br>anchoring or supporting tooth replacements to restore<br>patient esthetics and chewing function.<br>NobelActive® implants are indicated for single or multiple<br>unit restorations in splinted or non-splinted applications.<br>This can be achieved by a 2-stage or 1-stage surgical<br>technique in combination with immediate, early or<br>delayed loading protocols, recognizing sufficient primary<br>stability and appropriate occlusal loading for the selected<br>technique.<br>NobelActive® 3.0 implants are intended to replace a<br>lateral incisor in the maxilla and/or a central or lateral<br>incisor in the mandible.<br>NobelActive® 3.0 implants are indicated for single unit<br>restorations only. | MIS V3 Conical Connection Dental Implant System is<br>intended to be surgically placed in the bone of the upper<br>or lower jaw arches to provide support for prosthetic<br>devices, such as artificial teeth, in order to restore<br>masticatory function. When a one-stage surgical<br>procedure is applied, the implant may be immediately<br>loaded when good primary stability is achieved and the<br>occlusal load is appropriate.<br>Narrow implants (Ø3.3mm) are indicated for use in<br>surgical and restorative applications for placement only<br>in the mandibular central, lateral incisor and maxillary<br>lateral incisor regions of partially edentulous jaws, to<br>provide support for prosthetic devices such as artificial<br>teeth, in order to restore the patient chewing function.<br>Mandibular central and lateral incisors must be splinted<br>if using two or more narrow implants adjacent to one<br>another. |…
