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

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 ImplantDescription	PlatformDesignation	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

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.

AI/ML Overview

The FDA document provided pertains to a 510(k) premarket notification for a dental implant system (NUVENTUS NV.C™ Dental Implant System). This document focuses on demonstrating substantial equivalence to predicate devices through engineering analysis, non-clinical performance data (e.g., mechanical testing, biocompatibility), and a review of clinical literature. It does not present a study proving the device meets specific acceptance criteria based on AI/ML performance metrics, expert consensus, or clinical outcomes from a new study specific to an AI device.

Therefore, I cannot extract the requested information regarding acceptance criteria, AI/ML study design (sample size, data provenance, expert ground truth, adjudication, MRMC study, standalone performance), or training set details because this information is not present in the provided text.

The document discusses performance data related to the dental implant itself (e.g., sterilization, biocompatibility, mechanical testing, surface analysis), and clinical literature data to support the substantial equivalence of the implant's design features with established predicate devices. The "Clinical Testing Literature Table" outlines existing studies on predicate implants, reviewing their clinical outcomes (like bone level changes) to support the subject device's design principles. This is not the same as a study testing an AI device's performance against defined acceptance criteria.

In summary: The provided text is a 510(k) submission for a dental implant system, not an AI/ML-based medical device. Thus, the requested details specific to AI/ML device performance and validation studies are not available in this document.

Summary

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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

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INDICATIONS FOR USE STATEMENT

Implant System Prosthetic Compatibility	Platform Size/Designation
Nobel Biocare Internal Conical Connection (CC)	NP CC
	RP CC

SUBJECT DEVICE DESCRIPTION

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 ImplantDescription	PlatformDesignation	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.

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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	SubjectDeviceDesignFeature	Implant	StudyDesign	Treatmentconcept	Clinical outcomes - Bone levelchanges	Relevance to NUVENTUS NV.C
	Gultekin BA, GultekinP. Leblebicioglu B.Basegmez C, Yalcin S.Clinical evaluation ofmarginal bone loss andstability in two types ofsubmerged dentalimplants. Int J OralMaxillofac Implants.2013 May-Jun;28(3):815-23	Internalconicalconnection	K142260NobelActive®Nobel BiocareAB.Nobel ReplaceTapered (NobelBiocare AB).	ProspectiveClinical Trial	Healed site(3 months)	The cumulative implantsurvival rate was 100%. At thesecond-stage surgery, bonelevels were similar betweengroups. One year after loading,mean crestal bone loss was 0.35± 0.13 mm for NobelActiveimplants and 0.83 ±0.16 mmfor NobelReplace implants, asignificant difference.	Both implant systems had the same survival rates.NobelActive implants with a built-in platform switch and conicalconnection with back-tapered collar design achieved higher primarystability at insertion and less bone resorption after 15 months. Conicalconnection of NUVENTUS NV.C is compatible to NobelActiveimplants.Relevant design feature for subject device: The conical connection ofNUVENTUS NV.CTM is compatible to NobelActive® implants. Thisarticle provides performance information based on the long-term datafor three-dimensional marginal bone level, implant stability, and peri-implant health that is considered to be relevant to the subject device.
2	Kolinski ML, Cherry JE,McAllister BS, ParrishKD, Pumphrey DW,Schroering RL.Evaluation of a variable-thread tapered implant inextraction sites withimmediatetemporization: a 3-yearmulticenter clinicalstudy. J Periodontol.2014 Mar;85(3):386-94.	Internalconicalconnection	K142260NobelActive®Nobel BiocareAB	ProspectiveMulticenterClinicalStudy	Freshextractionsockets	Thirty-five implants wereevaluated at both implantinsertion and 3-year follow-up.There was a slight decrease inmean bone level from -0.68 mmat implant insertion to -0.93 mmat the 6-month recall and thenan increase of bone to -0.53 mmfrom the reference point at the2-year follow-up (an averageincrease of 0.15 mm fromimplant insertion).	The results showed stable bone and soft tissue levels around thisimplant after 3 years in function, indicating that the implant can beused safely and effectively under the demanding conditions ofimmediate loading on implants placed in extraction sockets while alsoproviding a high level of patient satisfaction. All implants werereported stable at the 6-month, 1-year, 2-year, and 3-year follow-ups.Relevant design feature for subject device: The conical connection ofNUVENTUS NV.CTM is compatible to NobelActive® implants. Thisarticle provides performance information based on the long-term datafor bone remodeling, survival rate, and soft tissue health that isconsidered to be relevant to the subject device.
3	Pozzi A, Agliardi E,Tallarico M, BarlattaniA. Clinical andradiological outcomes oftwo implants withdifferent prostheticinterfaces and neckconfigurations:randomized, controlled,split-mouth clinical trial.Clin Implant Dent RelatRes. 2014 Feb;16(1):96-106.	Internalconicalconnection	K142260NobelActive®Nobel BiocareAB.Nobel SpeedyGroovy, NobelBiocare AB.	RandomizedControlledTrial	Healed site(6 months)	No implants and prosthesisfailed. Survival rate was 100%.Marginal bone changes werestatistically significantlydifferent with better results forthe internal conical connection:mean marginal bone loss (mm)(SD): 0.37 (0.23) for NobelActive, vs 0.95 (0.56) for NobelSpeedy Groovy from baseline to16 weeks (unloaded period).	Both implant designs (NobelActive K142260 and NobelSpeedyGroovy K160119 investigated provided successful results; however,the MBL was statistically significantly lower in the back-tapered neckconfiguration with conical connection of K142260 - equivalent internalconical connection, as NUVENTUS NV.C.Relevant design feature for subject device: The conical connection ofNUVENTUS NV.CTM is compatible to NobelActive® implants. Thisarticle provides performance information based on the long-term datacomparing clinical and radiological outcomes that is considered to berelevant to the subject device.
4	Li Manni L. Lecloux G.Rompen E, Aouini W,Shapira L, Lambert F.Clinical and radiographicassessment of circularversus triangularcrosssection neckImplants in the posteriormaxilla: A 1-yearrandomized controlledtrial. Clin Oral ImplantsRes. 2020Sep;31(9):814-824.	Triangularneckdesign	K163349MIS V3ConicalConnectionDental ImplantSystemMIS ImplantsTechnologiesLtd.MIS C1 DentalImplantSystem.	RandomizedControlledTrial	Healed site(12 weeks)	No implant loss occurred withinthe follow-up period. The mean± SD peri-implant proximalbone loss 1-year after loadingwas 0.22 ± 0.30 mm fortriangular and 0.42 ± 0.67 mmfor circular implants necks(p=0.25).	Circular and triangular (K163349) cross-section neck implants in theposterior maxilla were similar with respect to peri-implant bonechanges. The implant neck design did not impact the pink aestheticscore and the patient satisfaction.Relevant design feature for subject device: Like the MIS V3, theNUVENTUS NV.CTM implant is designed with coronal flutes. Thisarticle provides performance information based on one-year datacomparing peri-implant bone changes of circular versus triangularcross-section neck implants that is considered to be relevant to thesubject device.
		SubjectDevice
		Design		Study	Treatment	Clinical outcomes - Bone level
Number	Citation	Feature	Implant	Design	concept	changes	Relevance to NUVENTUS NV.C
5	Hurtgen A, Seidel L,Manni LL, Liegeois L,Lecloux G, Lambert F.Clinical and radiographicassessment of circularversus triangular cross-section neck implants inthe posterior maxilla:Five-year follow-up of arandomized controlledtrial. Clin Oral ImplantsRes. 2023 Jul;34(7):698-706.	Triangularneckdesign	K163349MIS V3ConicalConnectionDental ImplantSystemMIS ImplantsTechnologiesLtd.MISC1 DentalImplantSystem.	RandomizedControlledTrial	Healed siteplacement(12 weeks)	No implant loss occurred duringthe 5-year follow up period. Themean ± SD proximal boneremodeling after 5 yearsreached 0.38 ± 0.39 mm for thecircular design and 0.29 ± 0.58mm for the triangular design (p= .49).	The 5-year evaluation of the triangular neck implants showed similarresults to the circular neck implants.Relevant design feature for subject device: The 5year clinical data forthe predicate with initial gap between implant collar and osteotomybone showed low rates of peri-implant bone loss and occurrence ofperiodontitis. This article provides relevant performance informationbased on assessing the peri-implant bone stability and the peri-implantsoft tissue conditions over 5-years and is considered to be relevant tothe subject device.
6	Tokuc B, Kan B. Theeffect of triangular cross-section neck design oncrestal bone stability inthe anterior mandible: Arandomized, controlled,splitmouth clinical trial.Clin Oral Implants Res.2021 Oct;32(10):1241-1250.	Triangularneckdesign(TN)	K163349MIS V3ConicalConnectionDental ImplantSystemMIS ImplantsTechnologiesLtd. MIS C1(circular neck,RN) DentalImplantSystem.	RandomizedControlledTrial	Healed site(3 months)	No implant loss was observedduring the follow-up period.The mean ± SD proximalcrestal bone loss one year afterloading was 0.58 ± 0.36 mm forTN and 0.91 ±0.59 mm for RN(p < 0.01).	The presentation of stable peri-implant soft tissue and crestal bonelevels in both circular and triangle (K163349) neck groups.Relevant design feature for subject device: This article providesperformance information comparing crestal bone loss and buccal bonethickness around a triangular cross-section neck to a round neck designover a one-year period of follow-up. Stable peri-implant soft tissue andcrestal bone levels were observed for both groups, which areconsidered to be relevant to the subject device.
7	Chu SJ, Östman PO,Nicolopoulos C.Yuvanoglu P, Chow J,Nevins M, Tarnow DP.Prospective MulticenterClinical Cohort Study ofa Novel Macro HybridImplant in MaxillaryAnterior PostextractionSockets: 1-Year Results.Int J PeriodonticsRestorative Dent.2018;38(Suppl):s17-s27.	Narrowcoronalsegmentof theimplant	K181850InversaImplants,SouthernImplant (Pty),Ltd	ProspectiveMulticenterCohort Study	Freshextractionsockets	No implants failed during anaverage healing period of oneyear. Marginal bone levelchanges: A tooth to-implantinterdental bone crest distanceand dimension of 2.3 to 2.6 mmwas reached; it was alsosustained at the 1-year follow-up. No marginal bone loss wasevaluated, as bone graft wasused.	As the Inversa implants have an even larger gap between implant collarand bone, they can be considered as the clinical worst-case.Predicate K181850 implants were considered to be safe and effective inthis study when the gap was filled with bone grafting material.Relevant design feature for subject device: As the Inversa implantshave an even larger and circumferential gap between implant collar andbone, they can be considered as the clinical worst-case. PredicateThis article provides relevant performance information, based on one-year data for a macro hybrid implant placed into maxillary anterior postextraction sockets, that is considered to be a clinical worst-case to thesubject device.
8	Chu SJ. Inverted body-shift concept inmacroimplant design toenhance biologic andesthetic outcomes: Aclinical report. J ProsthetDent. 2021Dec;126(6):720-726.	Narrowcoronalsegmentof theimplant	K181850InversaImplants,SouthernImplant (Pty),Ltd	Clinicalreport	Freshextractionsockets	At 6 months post surgery, atooth to-implant distance at thedistal aspect of the centralincisor implant between thecentral and lateral incisors was1.8 mm. No measurements ofmarginal bone loss as bonegrafting was performed.	Reduction of the load on the buccal bone, as our selected predicatedevices prove the benefit of such designs regarding clinical long-termperformance and crestal bone maintenance.Relevant design feature for subject device: As the Inversa implantshave an even larger and circumferential gap between implant collar andbone, they can be considered as the clinical worst-case. PredicateInversa implants showed good clinical performance and crestal bonemaintenance during the study when the gap was filled with bonegrafting material. This article provides relevant performanceinformation based on the data, which is considered to be a clinicalworst-case to the subject device.
		SubjectDevice
		Design		Study	Treatment	Clinical outcomes - Bone level
Number	Citation	Feature	Implant	Design	concept	changes	Relevance to NUVENTUS NV.C
9	Gluckman H, Pontes CC,Chu S. Immediate ToothReplacement in theEsthetic Zone with theSocket Shield Techniqueand a Novel Body-ShiftImplant: A Pilot Studywith Up to 3 Years ofFollow-up. Int JPeriodontics RestorativeDent. 2023 Oct24;(7):s107-s117.	Narrowcoronalsegmentof theimplant	K181850InversaImplants,SouthernImplant (Pty),Ltd	Pilot study	Freshextractionsockets	Patients were followed up for12 to 39 months (mean$18.1\pm8.2$ months). The survivalrate was 100%. Meaninterproximal marginal boneloss was $-0.4\pm0.5$ mm	As the Inversa implants have an even larger gap between implant collarand bone, they can be considered as the clinical worst-case. PredicateK181850 implants were considered to be safe and effective in thisstudy.Relevant design feature for subject device: As the predicate Inversaimplants have an even larger and circumferential gap between implantcollar and bone, they can be considered as the clinical worst-case. Thepredicate device showed good clinical performance and crestal bonemaintenance during the study when the gap was filled with bonegrafting material. This article provides relevant performanceinformation for marginal bone loss for the predicate device, which isconsidered to be a clinical worst-case to the subject device.
10	O'Hooley, DominicBrenden, CostaNicolopoulos, MarkWorthing, PetrosYuvanoglu, Fotis Melas,and Peter Fairbairn."Outcomes of a OneYear, RetrospectiveSingle-Arm CohortStudy Using both aNovel Body-ShiftImplant Design with aNovel AlloplasticParticulate GraftingMaterial in ImmediateExtraction Sockets."(2023)	Narrowcoronalsegmentof theimplant	K181850InversaImplants,SouthernImplant (Pty),Ltd	RetrospectiveSingle-ArmCohort Study	Freshextractionsockets	In this study, only the newbuccal bone and the PES of thesoft tissue are measured. Nomeasurements of marginal boneloss as bone grafting wasperformed.	The relatively narrow coronal portion of the Inversa implant along withthe use of bone grafting material appears to have improved boneregeneration in the critical aesthetic coronal zone for enhanced tissuestability. As the Inversa implants have an even larger gap betweenimplant collar and bone, they can be considered as the clinical worst-case. Predicate K181850 implants were considered to be safe andeffective in this study.Relevant design feature for subject device: As the Inversa implantshave an even larger and circumferential gap between implant collar andbone, they can be considered as the clinical worst-case. PredicateInversa implants were considered by the investigators to be safe andeffective in this study, as the predicate devices showed good clinicalperformance and crestal bone maintenance during the study. Thisarticle provides relevant performance information for stability of thepredicate device while using bone augmentation material placed in thecircumferential 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	SubstantialEquivalence
	K233081Infinitum Eta Ltd.NUVENTUS NV.CTM Dental Implant System	K142260NobelActive®Nobel BiocareAB	K163349MIS V3 Conical Connection Dental ImplantSystem MIS Implants Technologies Ltd.	K181850Inversa Implants SouthernImplant (Pty) Ltd.
Indications forUse Statement	NUVENTUS NV.CTM Dental Implants are indicated for thefunctional and esthetic oral rehabilitation of the upper or lowerjaw of edentulous or partially edentulous patients. NUVENTUSNV.CTM Dental Implants may be used for immediate, early orlate implantation following the extraction or loss of natural teeth.The implants can be placed with immediate function for single-tooth and/or multiple tooth restorations when good primarystability is achieved and with appropriate occlusal loading torestore chewing function. NUVENTUS NV.CTM Dental Implantsare compatible for use with the following prosthetic interfaces.Implant System ProstheticCompatibilityPlatformSize/DesignationNobel Biocare Internal ConicalConnection (CC)NP CCRP CC					NobelActive® implants are endosseous implants intended tobe surgically placed in the upper or lower jaw bone foranchoring or supporting tooth replacements to restorepatient esthetics and chewing function.NobelActive® implants are indicated for single or multipleunit restorations in splinted or non-splinted applications.This can be achieved by a 2-stage or 1-stage surgicaltechnique in combination with immediate, early ordelayed loading protocols, recognizing sufficient primarystability and appropriate occlusal loading for the selectedtechnique.NobelActive® 3.0 implants are intended to replace alateral incisor in the maxilla and/or a central or lateralincisor in the mandible.NobelActive® 3.0 implants are indicated for single unitrestorations only.	MIS V3 Conical Connection Dental Implant System isintended to be surgically placed in the bone of the upperor lower jaw arches to provide support for prostheticdevices, such as artificial teeth, in order to restoremasticatory function. When a one-stage surgicalprocedure is applied, the implant may be immediatelyloaded when good primary stability is achieved and theocclusal load is appropriate.Narrow implants (Ø3.3mm) are indicated for use insurgical and restorative applications for placement onlyin the mandibular central, lateral incisor and maxillarylateral incisor regions of partially edentulous jaws, toprovide support for prosthetic devices such as artificialteeth, in order to restore the patient chewing function.Mandibular central and lateral incisors must be splintedif using two or more narrow implants adjacent to oneanother.	Inversa Implants are intended for surgical placement in theupper or lower jaw to provide a means for prostheticattachment of crowns, bridges or overdentures utilizingdelayed or immediate loading.Inversa Implants are intended for immediate functionwhen good primary stability with appropriate occlusalloading is achieved.	Similar indications,slightly differentwording — noadditional risk forsubstantial equivalence
Reason forPredicate Device	Not applicable	Implant design including length range, diameters,prosthetic connection, and Indications for Use limitations;materials; manufacturing; sterilization	Implant design including external macro geometry;material; external surface modification	Engagement of the coronal features with the bone of theosteotomy	n/a
Product Codes	DZE, NHA	DZE, NHA	DZE, NHA	DZE	Identical product codes
Intended Use	Functional and esthetic rehabilitation of the edentulous mandible ormaxilla	Functional and esthetic rehabilitation of the edentulousmandible or maxilla	Functional and esthetic rehabilitation of the edentulousmandible or maxilla	Functional and esthetic rehabilitation of the edentulousmandible or maxilla	Identical intended use
Implant BodyDesign	Straight with apical taper, externally threaded, facial/lingual groovedflutes	Expanding taper, externally threaded, drilling blades onapex	Tapered, externally threaded, three-way cutawaylongitude implant axis at the cervical part of the implant	Fully threaded, tapered, root-form dental implants with adesign feature known as body shift, where the bodydesign of the implant has a narrow, straight coronalportion with an increased maximum diameter midwaydown the length of the implant tapering toward the apex.The body of the implant includes two thread types(square and V-shaped) that transition in the middle of theimplant body.	Similar screw-typeimplant design withdifferences in thecoronal part of theimplants, differenceswere assessed withcomparativenonclinical testing,literature review, andlabeling mitigations
ProstheticInterfaceConnections	Internal conical connection with internal hexagon anti-rotationalengagement	Internal Conical Connection with internal hexagon anti-rotational engagement	Internal conical connection with 3- or 6-sided anti-rotational index.	External hex and deep conical double hex anti-rotationalengagement	Identical to the primarypredicate. Subject andpredicate devices allhave internal conicalconnections. The subjectdevice conicalconnection was reverseengineered from theconnection of theprimary predicate.
Body/PlatformDiameters	Body Ø, mm / Platform Name (Seating Ø, mm)3.5 / NP (3.0)4.3 / NP (3.0);5.0 / RP (3.4)	Body Ø, mm / Platform Name (Seating Ø, mm)3.0 / 3.0 (2.5)3.5 / NP (3.0)4.3, 5.0 / RP (3.4)5.5 / WP (4.4)	3.3 / NP (2.75)3.9, 4.3, 5.0 / SP (3.15)	Deep Conical3.6 coronal - 4.5 apical (max) / 3.13.6 coronal - 5.0 apical (max) / 3.14.0 coronal - 5.0 apical (max) / 3.1	Similar. Body/Platformdiameters of subjectdevice are in the range ofpredicate devices
Lengths, mm	8.0 – 15, all body diameters	Ø 3.0 – 10-15;Ø 3.5, 4.3, 5.0 – 8.5-18;Ø 5.5 – 7.0-15	Ø 3.3 – 10-16;All other body diameters – 8-16	11.5, 13, 15, 18	Similar. Subjectimplant lengths are inthe same range aspredicate devices
Implant Material	Titanium alloy, ASTM F136	Unalloyed titanium	Titanium alloy, ASTM F136	Unalloyed titanium	Identical. Subjectdevice and referencepredicate #1 have thesame material

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	Subject Device	Primary Predicate Device	Reference Device	Reference Device	SubstantialEquivalence
	K233081Infinitum Eta Ltd.NUVENTUS NV.CTM Dental Implant System	K142260NobelActive®Nobel BiocareAB	K163349MIS V3 Conical Connection Dental ImplantSystem MIS Implants Technologies Ltd.	K181850Inversa Implants SouthernImplant (Pty) Ltd.
ImplantEndosseaousSurface	Blasted with resorbable media and acid etched	TiUnite	Sand blasted and acid etched	Grit blasted	Similar surfaces withthe same function
Cover ScrewMaterials	Titanium alloy, ASTM F136	Titanium alloy, ASTM F136	Titanium alloy, ASTM F136	Not stated in 510(k) Summary	Identical
Cover ScrewColoration	Titanium anodization	N/A	Titanium anodization	Not stated in 510(k) Summary	Identical to thereference device
How Provided
Implants	Sterile by gamma irradiation	Gamma irradiation	Radiation	Gamma irradiation	Identical
Cover Screws	Sterile by gamma irradiation	Not stated in 510(k) Summary	Not stated in 510(k) Summary	Not stated in 510(k) Summary	Identical
Usage	Single patient, single use	Single patient, single use	Single patient, single use	Single patient, single use	Identical

Regulation Number and Section

§ 872.3640 Endosseous dental implant.

(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.