K3Pro Konus New Abutments and Implants

K190192 · Argon Med. Productions Vertriebs Gesellschaft Mbh CO KG · DZE · Feb 10, 2020 · Dental

Device Facts

• Record ID: K190192
• Device Name: K3Pro Konus New Abutments and Implants
• Applicant: Argon Med. Productions Vertriebs Gesellschaft Mbh CO KG
• Product Code: DZE · Dental
• Decision Date: Feb 10, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The K3Pro® Konus New Abutments are designed to be compatible with the K3Pro® Konus Dental Implant system and are for use in edentulous sites in the maxilla for support of a complete denture prosthesis, a final or intermediate abutment for fixed bridgework or for partial dentures, or as a single tooth replacement. Delayed loading is recommended. The Ø7, 8, and 9mm implants are intended only for implantation in the maxillary or mandibular molar region where bone exists and the surgeon has determined that the placement of a narrower diameter implant would increase the probability of failure due to poor primary stability, or increased surgical procedures leading to complications. All digitally designed abutments for use with K3Pro® New Abutments and Implants are intended to be sent to an Argon validated milling center for manufacture.

Device Story

System comprises endosseous dental implants and Ti-Base abutments; used in edentulous sites for prosthetic support. Implants (7-9mm diameter) feature Grade 4 titanium construction, Osteo-Active™ surface treatment, self-tapping threads, and conical body with 3° total taper. Abutments (2-3mm platform) utilize Grade 5 Ti-6Al 4V-ELI titanium alloy; designed for patient-specific fabrication via CAD/CAM (e.g., 3Shape software) at validated milling centers. Zirconia copings/crowns (Y-TZP) may be luted to Ti-Base abutments using FDA-cleared cement. Clinicians perform surgical placement (1mm subcrestal) and prosthetic restoration. System provides mechanical stability for fixed/removable dentures or single-tooth replacements. Benefits include improved primary stability in molar regions and customized prosthetic fit via digital workflows.

Clinical Evidence

No clinical data or animal testing conducted. Substantial equivalence supported by bench testing: sterilization validation (ISO 11137-3, ISO 11138-3), drying time validation (ANSI/AAMI ST79), pyrogenicity (USP 85), biocompatibility (ISO 1099-1, ISO 1099-5), and fatigue testing (ISO 14801).

Technological Characteristics

Materials: Grade 4 Titanium (implants/screws), Grade 5 Ti-6Al 4V-ELI (abutments, ASTM F136), Y-TZP Zirconia (ISO 13356). Design: Conical implant-abutment connection (3° total taper). Sterilization: Gamma (implants) and Steam (abutments). Connectivity: Compatible with CAD/CAM design software (e.g., 3Shape).

Indications for Use

Indicated for edentulous patients in the maxilla or mandible requiring support for complete denture prostheses, fixed bridgework, partial dentures, or single tooth replacement. Ø7, 8, and 9mm implants are indicated for maxillary or mandibular molar regions where bone exists and narrower implants risk failure due to poor primary stability or surgical complications. Delayed loading recommended.

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

• K3Pro® Konus Additional Abutments and Implants (K160581)

Reference Devices

• NSI Endosseous Dental Implant System (K071161)
• Certain BellaTek® Express and BellaTek® Flex Abutments (K183138)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

February 2, 2020

Argon Med. Productions Vertriebs Gesellschaft MBH Co Kg % Celline Lakus Business Manager Argon Dental USA. LLC 1000 Corporate Drive Marshfield, Wisconsin 54449

Re: K190192

Trade/Device Name: K3Pro® Konus New Abutments and Implants Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: January 14, 2020 Received: January 14, 2020

Dear Celline Lakus:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

{1}------------------------------------------------

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

Srinivas Nandkumar, Ph.D. for Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

## Indications for Use

## 510(k) Number (if known) K190192

### Device Name

K3Pro® Konus New Abutments and Implants

### Indications for Use (Describe)

The K3Pro® Konus New Abutments are designed to be compatible with the K3Pro® Konus Dental Implant system and are for use in edentulous sites in the maxilla for support of a complete denture prosthesis, a final or intermediate abutment for fixed bridgework or for partial dentures, or as a single tooth replacement. Delayed loading is recommended.

The Ø7, 8, and 9mm implants are intended only for implantation in the maxillary or mandibular molar region where bone exists and the surgeon has determined that the placement of a narrower diameter implant would increase the probability of failure due to poor primary stability, or increased surgical procedures leading to complications.

All digitally designed abutments for use with K3Pro® New Abutments and Implants are intended to be sent to an Argon validated milling center for manufacture.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|
| <label><input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> | <label><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> |

## CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image is a logo for K3pro KONUS DENTAL IMPLANTS. The logo features the text "K3pro" in a stylized font, with the "K3" portion in red and the "pro" portion in gray. Below the text is the phrase "KONUS DENTAL IMPLANTS" in a smaller, sans-serif font. The logo is likely used to represent a dental implant company or product.

K190192

Image /page/3/Picture/2 description: The image shows the logo for Argon Medical Devices & Dental Implants. The word "Argon" is written in large, red, bold letters. Below the word "Argon" is the phrase "MEDICAL DEVICES & DENTAL IMPLANTS" in smaller, red letters. There is a red curved line above the word "Argon".

| Date<br>Submitted | February 1, 2019 | Revision<br>Date | February 10, 2020 |
|-----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------|-------------------|
| Manufacturer<br>and Address | Argon Medical Productions & Vertriebs Gesellschaft mbH & Co. KG<br>Franz-Kirsten-Str. 1<br>Bingen am Rhein, Germany, 55411 | | |
| Manufacturer<br>Contact | Richard Donaca<br>CEO/Managing Director<br>Tel: [phone]<br>Fax: [phone] | | |
| US Agent | Argon Dental USA, LLC<br>1000 Corporate Dr.<br>Marshfield, WI. 54449 | | |
| US Agent<br>Contact | Celline Lakus<br>Business Manager<br>Tel:[phone]<br>Fax:[phone] | | |
| Proposed<br>Trade Name | K3Pro® Konus New Abutments and Implants | | |
| Common<br>Name | Endosseous Dental Implants | | |
| Device Class | Class II | | |
| Regulation | 21 CFR 872.3640 | | |
| Device<br>Product<br>Codes | DZE: Primary<br>NHA: Secondary | | |
| Purpose | The purpose of this submission is to expand the Argon Medical K3Pro® Konus Dental Implant System<br>components cleared under K141159 and K160581. As such, this submission includes new implant bodies and<br>additional abutments for previously cleared K3Pro® Implants (K141159 and K160581). | | |

{4}------------------------------------------------

Image /page/4/Picture/0 description: The image shows the logo for K3pro Konus Dental Implants. The logo features the text "K3pro" in a stylized font, with the "K3" in gray and the "pro" in red. The text "KONUS DENTAL IMPLANTS" is located below the main logo in a smaller font, set against a red background. The overall design is clean and professional, reflecting the dental industry it represents.

Image /page/4/Picture/2 description: The image shows the logo for Argon Medical Devices & Dental Implants. The word "Argon" is written in large, red, bold letters. Below the word "Argon" is the phrase "MEDICAL DEVICES & DENTAL IMPLANTS" in smaller, red letters. A red curved line is above the word "Argon".

- D The connection portion and the subject devices are manufactured by Argon Medical Productions & Vertriebs Gesellschaft mbH & Co. KG of Germany, the additional devices are part of the previously FDA cleared K3Pro® Konus Dental Implant System K141159 and K3Pro® Additional Abutments and Implants K160581.
- > The Abutments in this submission are in two prosthetic platform diameters (2.0mm & 3.0mm). The abutments are designed to fit and function only on the previously cleared K3Pro® Konus Dental Implants (K141159), the additional implants submitted in K3Pro® Additional Abutments and Implants (K160581) and the implants submitted in this submission. They have the same Konus connection and are screw retained.
- A Abutment screws: They are made of the same Titanium as the implants (pure, grade 4 titanium), to fix abutments to the underlining dental implant.
- > All K3Pro® abutments and implant bodies are not reusable, and they are for single use only.
- A The K3Pro® Implants in this submission are 7.0mm and 8.0mm in diameter. They are provided in 3.0mm platform only and range in length from 8.0 to 11.0mm (8.0, 9.0 and 11.0mm). They are manufactured from pure Grade 4 titanium. The implant surface has been treated with Osteo-Active™ (cleared in K141159) and is identical to all other K3Pro® Implants cleared on submissions K141159 and K160581. They have a selftapping thread design, cutting groove and conical implant body which allows for a directed implant placement. The K3Pro® Implant System connects the implant and abutment with a 1.5° taper per side (total 3° taper). The implant has sloping shoulder and is intended to be 1mm subcrestally inserted and for delayed loading.

| Picture | Implant<br>Diameter | Platform<br>Diameter | Implant Lengths | Implant Material |
|----------------|---------------------|----------------------|------------------------|-------------------------------------------------|
| Image: Implant | 7.0mm | 3mm | 8.0, 9.0 and<br>11.0mm | Grade 4 Ti with Osteo-Active™ surface treatment |
| Image: Implant | 8.0mm | 3mm | 8.0, 9.0 and<br>11.0mm | Grade 4 Ti with Osteo-Active™ surface treatment |

#### A Implants in this submission are available in the following diameters and lengths:

The K3Pro® Implants in this submission are compatible with ALL 3.0mm platform abutments in this submission as well as 3.0mm platform abutments cleared in K141159 and K160581 (Sure, Rapid and Short).

- A The K3Pro® Ti-Base Abutments in this submission – KSA, CG.V and CS abutments – are provided in two platform diameters (2.0mm & 3.0mm). Angled abutments and the 2mm connection implants are to be used in splint or multi- unit restorations only and not in single tooth restorations. These are only recommended for the incisor region of the mouth. Ø4.0 diameter implants and angled abutments (CG.C, CG.V, KSA) are only recommended for use in the anterior of the mouth. Ø4.0 diameter implants and CS angled abutments are only recommended for use in the incisor region of the mouth. The subject abutments are made of titanium alloy (Grade 5 Ti-6Al 4V-ELI), conforming to ASTM F136 Standard Specification for Wrought Titanium- 6Aluminum4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401), same material as the K3Pro® abutments previously cleared in K141159 and K160581. The screws are made from Grade 4 Titanium, the same material as the implants. The subject abutments are only compatible with K3Pro® Konus Dental Implants cleared in K141159 and K160581, and the implant bodies in this submission.
Device Description and Intended Use

{5}------------------------------------------------

Image /page/5/Picture/0 description: The image contains a logo for K3pro Konus Dental Implants. The logo features the text "K3pro" in a stylized font, with the "K3" portion in red and the "pro" portion in gray. Below the logo, the text "KONUS DENTAL IMPLANTS" is written in a smaller font and is contained within a red box.

Image /page/5/Picture/2 description: The image is a logo for Argon, a company that specializes in medical devices and dental implants. The word "Argon" is written in large, bold, red letters, with the words "MEDICAL DEVICES & DENTAL IMPLANTS" written in smaller, red letters underneath. A red swoosh arcs over the word "Argon."

| | Ti-Base<br>Abutment<br>Type | Platform<br>Diameter<br>(mm) | Abutment<br>Diameter<br>(mm) | Abutment<br>Gingival<br>Height<br>(mm) | Abutment<br>Angulation | Abutment<br>Material | Implant to Abutment<br>Compatibility |
|-------------------------------------------------------------|-----------------------------|------------------------------|------------------------------|----------------------------------------|------------------------|---------------------------|----------------------------------------------------------------------------------------------------------------------------|
| Device<br>Description<br>and Intended<br>Use<br>(continued) | KSA<br>(Subject<br>Device) | 2mm | 4.0mm | 0.5, 1.5 and<br>2.5mm | 0, 10 and<br>20° | Grade 5 Ti-<br>6Al 4V-ELI | 3.0 and 3.5mm Sure and<br>Rapid (cleared in<br>K141159) |
| | | 3mm | 5.0mm | 0.5, 1.5 and<br>2.5mm | 0, 10 and<br>20° | Grade 5 Ti-<br>6Al 4V-ELI | 4.0, 4.5, 5.0, 6.0mm<br>Sure, Rapid and Short<br>(cleared in K141159 and<br>K160581)<br>7.0 and 8.0mm<br>(Subject Devices) |
| | CG.C<br>(Subject<br>Device) | 2mm | F1 (Front)<br>P2 (Incisor) | 1.5mm | 0° | Grade 5 Ti-<br>6Al 4V-ELI | 3.0 and 3.5mm Sure and<br>Rapid (K141159) |
| | | 3mm | P2 (Incisor)<br>M1 (Molar) | 0.5 and<br>1.5mm | 0° | Grade 5 Ti-<br>6Al 4V-ELI | 4.0, 4.5, 5.0, 6.0mm<br>Sure, Rapid and Short<br>(cleared in K141159 and<br>K160581)<br>7.0 and 8.0mm<br>(Subject Devices) |
| | CG.V<br>(Subject<br>Device) | 2mm | 4.0mm | 0.5 and<br>1.5mm | 0° | Grade 5 Ti-<br>6Al 4V-ELI | 3.0 and 3.5mm Sure and<br>Rapid (cleared in<br>K141159) |
| | | 3mm | 4.0mm | 0.5 and<br>1.5mm | 0° | Grade 5 Ti-<br>6Al 4V-ELI | 4.0, 4.5, 5.0, 6.0mm<br>Sure, Rapid and Short<br>(cleared in K141159 and<br>K160581)<br>7.0 and 8.0mm<br>(Subject Devices) |
| | CS<br>(Subject<br>Device) | 2mm | 4.0mm | 0.5 and<br>1.5mm | 0° | Grade 5 Ti-<br>6Al 4V-ELI | 3.0 and 3.5mm Sure and<br>Rapid (cleared in<br>K141159) |
| | | 3mm | 4.0 and<br>4.5mm | 0.5 and<br>1.5mm | 0° | Grade 5 Ti-<br>6Al 4V-ELI | 4.0, 4.5, 5.0, 6.0mm<br>Sure, Rapid and Short<br>(cleared in K141159 and<br>K160581)<br>7.0 and 8.0mm<br>(Subject Devices) |

abutments. They are manufactured by Argon Medical Productions of Germany and are for use with only the K3Pro® Implants. They are made of titanium alloy, have a prefabricated, precision interface (implant/abutment connection) and are to be used for fabrication of patient-specific abutments using FDA cleared CAD/CAM technology such as 3Shape Abutment Design Software (K151455). Each patient-specific abutment is individually prescribed by the clinician and manufactured by an Argon Medical Productions validated milling center.

A The Zirconium coping and/or crown of the K3Pro® Ti-Base type abutments are to be made of biocompatible ZrO2 conforming to ISO 13356:2015 - Implants for surgery – Ceramic materials based on yttrio-stabilized tetragonal zirconia (Y-TZP) and luted to the abutment with an FDA cleared cement (MultiLink Hybrid Cement - K130436 is the product used in the ISO 14801 testing for this submission).

{6}------------------------------------------------

Image /page/6/Picture/0 description: The image is a logo for K3pro Konus Dental Implants. The logo features the text "k3pro" in a stylized font, with the "3" in red and the "k" and "pro" in gray. Below the text is the phrase "KONUS DENTAL IMPLANTS" in a smaller, sans-serif font, set against a red background. The overall design is clean and modern, suggesting a professional and innovative dental company.

Image /page/6/Picture/2 description: The image shows the logo for Argon Medical Devices & Dental Implants. The word "Argon" is written in large, red, bold letters. Below the word "Argon" is the phrase "MEDICAL DEVICES & DENTAL IMPLANTS" in smaller, thinner, red letters. A red swoosh appears above the word "Argon".

| ➤ The zirconia superstructure/coping and abutment bodies, follows the minimum and maximum tolerances: | | | | | |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|--------|--------|--------|
| NOTE 1: The total angulation of abutment base and zirconia coping should not exceed the angulation listed above | | | | | |
| Zirconia Coping/Abutment Tolerances | | | | | |
| | CG.C | CG.V | KSA | CS | |
| Device<br>Description<br>and Intended<br>Use<br>(continued) | Minimum Wall Thickness | 0.5mm | 0.5mm | 0.5mm | 0.5mm |
| | Minimum Emergence<br>Diameter | 3.3mm | 3.3mm | 3.3mm | 3.3mm |
| | Maximum Angulation | 30° | 0° | 20° | 0° |
| | Minimum Cementable<br>Height from Emergence<br>Profile | 4mm | 4mm | 4mm | 4mm |
| | Maximum Cementable<br>Height from Emergence<br>Profile | 14.2mm | 14.2mm | 14.2mm | 14.2mm |
| NOTE 2: 30° Abutments and the 2 mm connection implants are to be used in splint or multi-unit restorations only<br>and not in single tooth restorations. These are not recommended for use in the posterior region of the mouth. | | | | | |
| Indications<br>for Use | The K3Pro® Konus New Abutments and Implants are designed to be compatible with the K3Pro® Konus Dental<br>Implant system and are for use in edentulous sites in the mandible or maxilla for support of a complete denture<br>prosthesis, a final or intermediate abutment for fixed bridgework or for partial dentures, or as a single tooth<br>replacement. Delayed loading is recommended.<br><br>The Ø7, 8, and 9mm implants are intended only for implantation in the maxillary or mandibular molar region<br>where bone exists and the surgeon has determined that the placement of a narrower diameter implant would<br>increase the probability of failure due to poor primary stability, or increased surgical procedures leading to<br>complications.<br><br>All digitally designed abutments for use with K3Pro® New Abutments and Implants are intended to be sent to an<br>Argon validated milling center for manufacture. | | | | |
| Predicate<br>Devices | PRIMARY:<br>1. K3Pro® Konus Additional Abutments and Implants (K160581)<br><br>REFERENCE:<br>2. NSI Endosseous Dental Implant System (K071161)<br>➤ Reference for 7.0 and 8.0 diameter implants<br>3. Certain BellaTek® Express and BellaTek® Flex Abutments (K183138)<br>➤ Reference for Ti-Base Hybrid abutments | | | | |

{7}------------------------------------------------

Image /page/7/Picture/0 description: The image is a logo for "K3pro KONUS DENTAL IMPLANTS". The "K3" is in a bold, red font, with the "3" partially overlapping the "K". The "pro" is in a gray font and is located to the right of the "K3". Below the "K3pro" is the text "KONUS DENTAL IMPLANTS" in a smaller, red font.

Image /page/7/Picture/2 description: The image shows the logo for Argon Medical Devices & Dental Implants. The word "Argon" is in large, red, bold letters. Below the word "Argon" are the words "MEDICAL DEVICES & DENTAL IMPLANTS" in smaller, red letters. There is a red curved line above the word "Argon".

## Comparison of INDICATIONS FOR USE

| System: | K3Pro® Konus New Abutments and<br>Implants | K3Pro® KonusAdditional<br>Abutments and Implants<br>(Primary Predicate) | NSI Endosseous Dental<br>Implants<br>(Reference Device for<br>proposed implants) | Certain BellaTek® Express and<br>BellaTek® Flex Abutments<br>(Reference Device for proposed<br>Ti-Base Hybrid abutments) | Similarities and<br>Differences |
|--------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) number | Subject Device | K160581<br>Primary Predicate | K071161<br>Reference Device | K183138<br>Reference Device | N/A |
| Indications for<br>Use | The K3Pro® Konus New Abutments<br>and Implants are designed to be<br>compatible with the K3Pro® Konus<br>Dental Implant system and are for<br>use in edentulous sites in the<br>mandible or maxilla for support of a<br>complete denture prosthesis, a final<br>or intermediate abutment for fixed<br>bridgework or for partial dentures,<br>or as a single tooth replacement.<br>Delayed loading is recommended.<br>The Ø7, 8, and 9mm implants are<br>intended only for implantation in<br>the maxillary or mandibular molar<br>region where bone exists and the<br>surgeon has determined that the<br>placement of a narrower diameter<br>implant would increase the<br>probability of failure due to poor<br>primary stability, or increased<br>surgical procedures leading to<br>complications.<br>All digitally designed abutments for<br>use with K3Pro® New Abutments<br>and Implants are intended to be<br>sent to an Argon validated milling<br>center for manufacture. | K3Pro® Konus<br>Additional Abutments<br>and Implants are<br>designed to be<br>compatible with the<br>K3Pro® Konus Dental<br>Implant system and are<br>for use in edentulous<br>sites in the mandible or<br>maxilla for support of a<br>complete denture<br>prosthesis, a final or<br>intermediate abutment<br>for fixed bridgework or<br>for partial dentures, or<br>as a single tooth<br>replacement. Delayed<br>loading is<br>recommended. The<br>prosthesis may be<br>secured to the<br>abutment by the use of<br>adhesives or<br>mechanically by the use<br>of a screw. | The NSI MAX Implant System<br>is intended for implantation<br>in the maxillary or mandibular<br>molar region where bone<br>exists and the surgeon has<br>determined that the<br>placement of a narrower<br>diameter implant would<br>increase the probability of<br>failure due to poor primary<br>stability, or increased surgical<br>procedures leading to<br>complications. This MAX<br>implant provides support for<br>fixed or removable dental<br>prostheses in a single tooth,<br>partially edentulous<br>prostheses, or full arch<br>prostheses. It further adds<br>the option for immediate<br>loading on single and splinted<br>multiple unit restorations<br>when good primary stability is<br>achieved and with<br>appropriate occlusal loading,<br>to restore chewing functions. | Certain BellaTek Express and<br>BellaTek Flex Abutments are<br>intended for use as<br>accessories to endosseous<br>dental implant to support a<br>prosthetic device in a partially<br>or completely edentulous<br>patient. A dental abutment is<br>intended for use to support<br>single and multiple tooth<br>prosthesis, in the mandible or<br>maxilla. The prosthesis can be<br>screw retained or cement<br>retained. All digitally<br>designed superstructure<br>and/or hybrid abutment<br>crowns for use with Certain<br>BellaTek Express and BellaTek<br>Flex Abutments are intended<br>to be sent to a Biomet 3i<br>validated milling center for<br>manufacture. | The subject<br>Indications for Use<br>first paragraph is<br>similar to the<br>primary predicate<br>Indications for Use.<br>Language specific to<br>validated milling<br>center has been<br>added, identical to<br>the reference device<br>used for this<br>technology<br>(K183138).<br>Additionally,<br>language specific to<br>the placement of<br>large diameter<br>implant bodies has<br>been added,<br>identical to the<br>reference device<br>used for this<br>technology<br>(K071161) |
| System: | K3Pro® Konus New Abutments and<br>Implants | K3Pro® KonusAdditional Abutments<br>and Implants<br>(Primary Predicate) | NSI Endosseous Dental Implants | Similarities and Differences | |
| 510(k) number | Subject Device | K160581<br>Primary Predicate | K071161<br>Reference Device | N/A | |
| Material of<br>Manufacture | Grade 4 Ti (commercially pure<br>titanium) | Grade 4 Ti (commercially pure<br>titanium) | Grade 4 Ti (commercially pure<br>titanium) | Same as implants in Primary and<br>Reference Devices (K160581 and<br>K071161) | |
| Implant Surface | OsteoActive® Surface | OsteoActive® Surface | SInergy™ Surface | Same as Primary Predicate K160581 | |
| Implant Body<br>Diameter | 7.0, 8.0mm | 4.0, 4.5, 5.0, 6.0mm | 8.0, 9.0mm | Different from Primary Predicate<br>(K160581)<br>Within Reference Device available<br>diameters (K071161). Subject device<br>proposes a smaller diameter than the<br>Reference Device, which does not<br>impact substantial equivalence. | |
| Implant<br>Body Length | 8.0, 9.0, 11.0mm | 5.5, 6.5, 7.5, 8.0, 9.0mm | 7.0, 9.0, 11.0, 13.0mm | 8.0 and 9.0mm lengths are within<br>range of Primary Predicate (K160581)<br>and 9.0 and 11.0mm length are within<br>range of Reference Device (K071161) | |
| Implant Platform | 3mm | 3mm | Not publicly available | Same as Primary Predicate K160581 | |
| Implant<br>Connection to<br>Abutment | Internal Hex alignment, 1.5° locking<br>conical taper, screw attachment or<br>cement | Internal Hex alignment, 1.5° locking<br>conical taper, screw attachment or<br>cement | Internal Tri-lobe hex connection<br>(TRI-NEX®), screw attachment or<br>cement | Same as Primary Predicate K160581…