KONUS DENTAL IMPLANT SYSTEM

K141159 · Argon Med. Productions Vertriebs Gesellschaft Mbh · DZE · Mar 11, 2015 · Dental

Device Facts

• Record ID: K141159
• Device Name: KONUS DENTAL IMPLANT SYSTEM
• Applicant: Argon Med. Productions Vertriebs Gesellschaft Mbh
• Product Code: DZE · Dental
• Decision Date: Mar 11, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2

Indications for Use

The Konus K3Pro and K3Pro Rapid Implant is designed for use in edentulous sites in the mandible or maxilla for support of a complete denture prosthesis, a terminal or intermediate abutment for fixed bridgework or for partial dentures, or as a single tooth replacement.

Device Story

The K3Pro Konus Dental Implant System consists of endosseous root-form implants (straight and tapered) and associated prosthetic components (abutments, cover screws, healing caps). Implants are placed into the mandible or maxilla to provide a foundation for dental prosthetics. The system utilizes a Morse-style taper connection (3° taper) with hexagonal orientation for abutment attachment. Components are manufactured from Grade 4 pure titanium (implants) and Grade 5 Ti-6Al-4V ELI titanium alloy (abutments). The device is used by dental professionals in a clinical setting to restore patient dentition. The system provides mechanical support for dentures, bridges, or single crowns, aiming to restore oral function and aesthetics.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by non-clinical bench testing, including fatigue testing (ISO 14801), corrosion resistance, and biocompatibility assessments, consistent with FDA guidance for root-form endosseous dental implants.

Technological Characteristics

Materials: Grade 4 pure titanium (implants), Grade 5 Ti-6Al-4V ELI titanium alloy (abutments). Design: Root-form, threaded, tapered/straight. Connection: Morse-style 3° taper with hexagonal orientation. Surface: Acid-etched. Dimensions: 3.0-6.0 mm diameter, 7.5-17 mm length. Sterilization: Not specified.

Indications for Use

Indicated for patients requiring dental restoration in the mandible or maxilla, including support for complete denture prostheses, fixed bridgework, partial dentures, or single tooth replacement.

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

• Bicon Implants (K092035)
• Implant-One (K102822)
• Friadent (K073075)
• NobelActive 3.0 (K102436)
• BioDenta Dental Implant System Bone Level Tapered (K133884)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of three faces in profile, stacked on top of each other, resembling a stylized human figure.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 11, 2015

Argon Med. Productions & Vertriebs Gesellschaft mbH & Co. KG c/o Ms. Linda Saylor Argon Medical USA, LLC 1000 Corporate Drive Marshfield, WI 54449

Re: K141159

Trade/Device Name: K3Pro Konus Dental Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE, NHA Dated: February 6, 2015 Received: February 9, 2015

Dear Ms. Saylor:

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. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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

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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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Tina
Kiang -S

for Erin I. Keith, M.S. Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K141159

Device Name Konus Dental Implant System

Indications for Use (Describe)

The Konus K3Pro and K3Pro Rapid Implant is designed for use in the mandible or maxilla for support of a complete denture prosthesis, a terminal or intermediate abutment for fixed bridgework or as a single tooth replacement.

| Type of Use (Select one or both, as applicable) | |
|----------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------|
| <div> <span> <span style="font-size: 20px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span>☐ Over-The-Counter Use (21 CFR 801 Subpart C)</span> </div> |

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## K141159

## Argon Medical Productions & Vertriebs Gesellschaft mbH & Co. KG 510(k) Summary

Image /page/3/Picture/3 description: The image shows a logo for a company called "Medical Argon". The word "Argon" is in red, and the word "Medical" is in white. The logo also includes the text "Quality & Design" and "Made in Germany". There is a small German flag in the bottom left corner of the logo. The background of the logo is gray.

| Date Submitted | January 15, 2014 |
|--------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer and Address | Argon Medical Productions & Vertriebs Gesellschaft mbH & Co. KG<br>Mainzer Street 346<br>Bingen am Rhein 55411 |
| Manufacturer Contact | Richard Donaca<br>CEO/Managing Director<br>Tel: [phone]<br>Fax: [phone] |
| US Agent | Argon Medical USA LLC<br>1000 Corporate Dr.<br>Marshfield, WI. 54449 |
| US Agent Contact | Linda Saylor<br>Regulatory Specialist<br>Tel:[phone]<br>Fax:[phone] |
| Proposed Trade Name | K3Pro Konus Dental Implant System |
| Device Classification | Class II |
| Regulation | 872.3640 |
| Device Product Codes | DZE & NHA |
| Device Description | The K3Pro Konus Dental Implant System include endosseous Rapid and Sure root<br>form and threaded, tapered and straight implants, they come in a range of diameter<br>sizes 3.0 mm to 6.0 mm and range in length from 7.5 mm to 17 mm. Cover screws,<br>healing caps, straight and angled dental implant abutments with threaded abutment<br>connection having a Morse style taper. With a range of 0° to 30 ° angle. Abutment<br>screws, temporary abutments, ball abutments, in a variety of diameters and heights to<br>accommodate differing patient anatomy.<br>The implants are manufactured from pure, implant-grade 4 titanium. The abutments<br>are manufactured from Grade 5 Ti-6A1 4V-ELI. The internal connection has a 2 mm<br>mini connection with a Konus connection with a 3° taper with a hexagonal<br>orientation. The Standard has a 3 mm Konus connection with a 3° taper with a<br>hexagonal orientation.<br>Cover screws and healing caps provide protection to the threads of the abutment<br>connection during endosseous and gingival healing. Cover screws are pre-packaged<br>with each implant. Healing caps are provided as an alternative to the cover screw and<br>are packaged separately. |
| Intended (Indications for) Use | The Konus K3Pro and K3Pro Rapid Implant is designed for use in edentulous sites in<br>the mandible or maxilla for support of a complete denture prosthesis, a terminal or<br>intermediate abutment for fixed bridgework or for partial dentures, or as a single tooth<br>replacement. |
| Materials | The K3Pro Konus Dental Implants are manufactured from Pure Titanium Grade 4 and<br>the abutments are manufactured from Titanium Grade 5 titanium alloy (Ti-6AI-4V<br>ELI) |
| Predicate Devices | Bicon Implants (K092035)<br>Implant-One (K102822)<br>Friadent (K073075)<br>NobelActive 3.0 (K102436)<br>BioDenta Dental Implant System Bone Level Tapered (K133884) |

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Substantial Equivalence and Technological Characteristics: The findogy of the K3Po Konus Dental Inplant System is the same as the previously cleared devices as shown below in appendix table A.

## Appendix Table A

| System: | K3Pro | Bicon Implants | Implant-One | Friadent | NobelActive 3.0 | BioDenta Dental Implant<br>System Bone Level Tapered |
|----------------------------|----------------------------------------------------------------------|----------------------------------------------------------|----------------------------------------------------------|------------------------------------|-------------------------------------------------|------------------------------------------------------|
| Material of<br>Manufacture | Grade 4 Ti<br>Grade 5 Ti-6Al<br>4V-ELI | Grade 5 Ti6A14V | | | Titanium and/or titanium alloy | |
| 510k (number) | New Device | K092035 | K102822 | K073075 | K102436 | K133884 |
| Endosseous implant | Root-form, Straight<br>and Tapered | Tapered | Root-form, Tapered | Root-form, Straight and<br>tapered | Root-form,<br>Straight and<br>tapered | Root-form, tapered |
| Method of stabilization | Threaded fixation | Threaded fixation | Threaded fixation | Threaded fixation | Threaded fixation | Threaded fixation |
| Range of Diameters | 3.0 - 6.0mm | 3.0 -6.0 mm | 3.25 - 5.5mm | 3.0 -6.5mm | 3.3 -6mm | 3.0 - 6.0 mm |
| Range of Lengths | 7.5-17mm | 5.0 - 11 mm | 8-14mm | 8-17mm | 8 - 16mm | 6.5 - 14 mm |
| Modified surface | Yes, acid etched | Blasted and acid<br>etched, or<br>hydroxylaptite treated | Yes, AI02 blasted | Yes, acid etched | Yes, microtextured<br>or HA coated | Yes, Spark Anodization |
| Connection to<br>abutment | Hex alignment,<br>1.5° locking<br>conical taper,<br>screw attachment | 1.5° Locking conical<br>taper connection | Hex alignment, 6°<br>included taper,<br>screw attachment | Hex alignment, screw<br>attachment | Hex alignment, 1°<br>taper, screw<br>attachment | Internal Hexagon 6° taper, |
| Abutments | Standard, Angled,<br>Ball, Gold coping | Standard, Angled, Non<br>Shouldered | Standard, Ball,<br>Gold coping | Standard, Ball, Gold<br>coping | Standard, Angled,<br>Ball, Gold coping | Ti Alloy (Ti 6A1 4V) |

Non-Clinical Testing: Non-clinical test data was used to substantial equivalence. Non-clinical testing consisted of performance fatigue testing in accordance with the FDA Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments and ISO 14801 Dentistry Inplants Dynamic Farigue Test for Endosseous Dental Implants. The fairger testing conducted indicates that the

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device is strong enough to withstand the anticipated in the Appendix table A above demonstrate the substantial equivalence to the predicate devices listed.

A series of performance tests were conducted to dental Implant System does not raise any new issues of sales of sales of salesy, and efficacy, These tests include: fairger, corrosion resistance and biocompatibility: The testing was done in accordance with ISO 14801 Dentist Fatigue Test for Endosseous Dental Implants Second Edition 11/15/2007 and the FDA Guidance Class II Special Controls Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments.

No "Non-Pyrogenic" marketing claims are being made for any of the devices in the K3Pro System.

"The Konus Dental Implant System has not been wall compatibility in the MR environment. It has not been tested for heating, migration, or image artifact in the MR environment. The safety of the MR environment is unknown. Scanning a patient who has this device may result in patient injury."

Clinical Testing: Non-Clinical test data was used of substantial equivalence. The substantially equivalent or exacty the same to the devices listed above in materials, range of diameters, and method of stabilization.

Conclusion: The subject device and the predicated des, have similar technological characteristics, and are made of similar if not identical materials. The subject devices encompass a very similar or the exact same range of physical dimensions, including diameter and length of the implants and diameter, height and angle of the abutments and a comparative surface area.