(371 days)
The K3Pro® Konus New Abutments and Implants 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.
The K3Pro® Konus New Abutments and Implants are components of the K3Pro® Konus Dental Implant System. The submission includes new implant bodies (7.0mm and 8.0mm diameter, 3.0mm platform, 8.0 to 11.0mm length) made of Grade 4 titanium with Osteo-Active™ surface treatment, and additional Ti-Base abutments (KSA, CG.V, and CS) in 2.0mm and 3.0mm platform diameters made of Grade 5 Ti-6Al 4V-ELI. The abutments are designed to fit and function only on previously cleared K3Pro® Konus Dental Implants (K141159, K160581) and the implants submitted in this submission. They have the same Konus connection and are screw retained. Abutment screws are made of Grade 4 titanium. All devices are for single use only. Digitally designed abutments are intended for fabrication of patient-specific abutments using FDA cleared CAD/CAM technology and manufactured by an Argon Medical Productions validated milling center. Zirconium coping and/or crown for Ti-Base abutments are made of ZrO2 and luted with an FDA cleared cement.
The provided text does not describe acceptance criteria for a device's performance, nor does it detail a study that proves the device meets such criteria.
Instead, the document is a 510(k) premarket notification letter from the FDA regarding the K3Pro® Konus New Abutments and Implants. It focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than establishing new performance criteria or conducting studies to meet specific acceptance thresholds.
The document discusses:
- Indications for Use: What the device is intended for.
- Technological Characteristics: How the device is similar to predicate devices in terms of materials, design, and manufacturing.
- Non-Clinical Testing: A list of tests performed (e.g., sterilization validation, biocompatibility, fatigue testing) to show that the new device performs similarly and safely to the predicate devices. These are equivalence tests, not performance tests against specified acceptance criteria.
Therefore, I cannot provide the requested information as it is not present in the given text. The document explicitly states: "No animal testing or human clinical trials have been conducted." and focuses on "similarities between the predicate and proposed devices" and "non-clinical performance to the predicates listed" to support substantial equivalence.
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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.
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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 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
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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) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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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.
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".
| DateSubmitted | February 1, 2019 | RevisionDate | February 10, 2020 |
|---|---|---|---|
| Manufacturerand Address | Argon Medical Productions & Vertriebs Gesellschaft mbH & Co. KGFranz-Kirsten-Str. 1Bingen am Rhein, Germany, 55411 | ||
| ManufacturerContact | Richard DonacaCEO/Managing DirectorTel: 011-49-6721-3096-0Fax: 011-49-6721-3096-29 | ||
| US Agent | Argon Dental USA, LLC1000 Corporate Dr.Marshfield, WI. 54449 | ||
| US AgentContact | Celline LakusBusiness ManagerTel:715-898-1434Fax:715-387-4100 | ||
| ProposedTrade Name | K3Pro® Konus New Abutments and Implants | ||
| CommonName | Endosseous Dental Implants | ||
| Device Class | Class II | ||
| Regulation | 21 CFR 872.3640 | ||
| DeviceProductCodes | DZE: PrimaryNHA: Secondary | ||
| Purpose | The purpose of this submission is to expand the Argon Medical K3Pro® Konus Dental Implant Systemcomponents cleared under K141159 and K160581. As such, this submission includes new implant bodies andadditional abutments for previously cleared K3Pro® Implants (K141159 and K160581). |
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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 | ImplantDiameter | PlatformDiameter | Implant Lengths | Implant Material |
|---|---|---|---|---|
| Image: Implant | 7.0mm | 3mm | 8.0, 9.0 and11.0mm | Grade 4 Ti with Osteo-Active™ surface treatment |
| Image: Implant | 8.0mm | 3mm | 8.0, 9.0 and11.0mm | 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
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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-BaseAbutmentType | PlatformDiameter(mm) | AbutmentDiameter(mm) | AbutmentGingivalHeight(mm) | AbutmentAngulation | AbutmentMaterial | Implant to AbutmentCompatibility | |
|---|---|---|---|---|---|---|---|
| DeviceDescriptionand IntendedUse(continued) | KSA(SubjectDevice) | 2mm | 4.0mm | 0.5, 1.5 and2.5mm | 0, 10 and20° | Grade 5 Ti-6Al 4V-ELI | 3.0 and 3.5mm Sure andRapid (cleared inK141159) |
| 3mm | 5.0mm | 0.5, 1.5 and2.5mm | 0, 10 and20° | Grade 5 Ti-6Al 4V-ELI | 4.0, 4.5, 5.0, 6.0mmSure, Rapid and Short(cleared in K141159 andK160581)7.0 and 8.0mm(Subject Devices) | ||
| CG.C(SubjectDevice) | 2mm | F1 (Front)P2 (Incisor) | 1.5mm | 0° | Grade 5 Ti-6Al 4V-ELI | 3.0 and 3.5mm Sure andRapid (K141159) | |
| 3mm | P2 (Incisor)M1 (Molar) | 0.5 and1.5mm | 0° | Grade 5 Ti-6Al 4V-ELI | 4.0, 4.5, 5.0, 6.0mmSure, Rapid and Short(cleared in K141159 andK160581)7.0 and 8.0mm(Subject Devices) | ||
| CG.V(SubjectDevice) | 2mm | 4.0mm | 0.5 and1.5mm | 0° | Grade 5 Ti-6Al 4V-ELI | 3.0 and 3.5mm Sure andRapid (cleared inK141159) | |
| 3mm | 4.0mm | 0.5 and1.5mm | 0° | Grade 5 Ti-6Al 4V-ELI | 4.0, 4.5, 5.0, 6.0mmSure, Rapid and Short(cleared in K141159 andK160581)7.0 and 8.0mm(Subject Devices) | ||
| CS(SubjectDevice) | 2mm | 4.0mm | 0.5 and1.5mm | 0° | Grade 5 Ti-6Al 4V-ELI | 3.0 and 3.5mm Sure andRapid (cleared inK141159) | |
| 3mm | 4.0 and4.5mm | 0.5 and1.5mm | 0° | Grade 5 Ti-6Al 4V-ELI | 4.0, 4.5, 5.0, 6.0mmSure, Rapid and Short(cleared in K141159 andK160581)7.0 and 8.0mm(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).
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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 | ||
| DeviceDescriptionand IntendedUse(continued) | Minimum Wall Thickness | 0.5mm | 0.5mm | 0.5mm | 0.5mm |
| Minimum EmergenceDiameter | 3.3mm | 3.3mm | 3.3mm | 3.3mm | |
| Maximum Angulation | 30° | 0° | 20° | 0° | |
| Minimum CementableHeight from EmergenceProfile | 4mm | 4mm | 4mm | 4mm | |
| Maximum CementableHeight from EmergenceProfile | 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 onlyand not in single tooth restorations. These are not recommended for use in the posterior region of the mouth. | |||||
| Indicationsfor Use | The K3Pro® Konus New Abutments and Implants are designed to be compatible with the K3Pro® Konus DentalImplant system and are for use in edentulous sites in the mandible or maxilla for support of a complete dentureprosthesis, a final or intermediate abutment for fixed bridgework or for partial dentures, or as a single toothreplacement. Delayed loading is recommended.The Ø7, 8, and 9mm implants are intended only for implantation in the maxillary or mandibular molar regionwhere bone exists and the surgeon has determined that the placement of a narrower diameter implant wouldincrease the probability of failure due to poor primary stability, or increased surgical procedures leading tocomplications.All digitally designed abutments for use with K3Pro® New Abutments and Implants are intended to be sent to anArgon validated milling center for manufacture. | ||||
| PredicateDevices | PRIMARY:1. K3Pro® Konus Additional Abutments and Implants (K160581)REFERENCE:2. NSI Endosseous Dental Implant System (K071161)➤ Reference for 7.0 and 8.0 diameter implants3. Certain BellaTek® Express and BellaTek® Flex Abutments (K183138)➤ Reference for Ti-Base Hybrid abutments |
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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 andImplants | K3Pro® KonusAdditionalAbutments and Implants(Primary Predicate) | NSI Endosseous DentalImplants(Reference Device forproposed implants) | Certain BellaTek® Express andBellaTek® Flex Abutments(Reference Device for proposedTi-Base Hybrid abutments) | Similarities andDifferences |
|---|---|---|---|---|---|
| 510(k) number | Subject Device | K160581Primary Predicate | K071161Reference Device | K183138Reference Device | N/A |
| Indications forUse | The K3Pro® Konus New Abutmentsand Implants are designed to becompatible with the K3Pro® KonusDental Implant system and are foruse in edentulous sites in themandible or maxilla for support of acomplete denture prosthesis, a finalor intermediate abutment for fixedbridgework or for partial dentures,or as a single tooth replacement.Delayed loading is recommended.The Ø7, 8, and 9mm implants areintended only for implantation inthe maxillary or mandibular molarregion where bone exists and thesurgeon has determined that theplacement of a narrower diameterimplant would increase theprobability of failure due to poorprimary stability, or increasedsurgical procedures leading tocomplications.All digitally designed abutments foruse with K3Pro® New Abutmentsand Implants are intended to besent to an Argon validated millingcenter for manufacture. | K3Pro® KonusAdditional Abutmentsand Implants aredesigned to becompatible with theK3Pro® Konus DentalImplant system and arefor use in edentuloussites in the mandible ormaxilla for support of acomplete dentureprosthesis, a final orintermediate abutmentfor fixed bridgework orfor partial dentures, oras a single toothreplacement. Delayedloading isrecommended. Theprosthesis may besecured to theabutment by the use ofadhesives ormechanically by the useof a screw. | The NSI MAX Implant Systemis intended for implantationin the maxillary or mandibularmolar region where boneexists and the surgeon hasdetermined that theplacement of a narrowerdiameter implant wouldincrease the probability offailure due to poor primarystability, or increased surgicalprocedures leading tocomplications. This MAXimplant provides support forfixed or removable dentalprostheses in a single tooth,partially edentulousprostheses, or full archprostheses. It further addsthe option for immediateloading on single and splintedmultiple unit restorationswhen good primary stability isachieved and withappropriate occlusal loading,to restore chewing functions. | Certain BellaTek Express andBellaTek Flex Abutments areintended for use asaccessories to endosseousdental implant to support aprosthetic device in a partiallyor completely edentulouspatient. A dental abutment isintended for use to supportsingle and multiple toothprosthesis, in the mandible ormaxilla. The prosthesis can bescrew retained or cementretained. All digitallydesigned superstructureand/or hybrid abutmentcrowns for use with CertainBellaTek Express and BellaTekFlex Abutments are intendedto be sent to a Biomet 3ivalidated milling center formanufacture. | The subjectIndications for Usefirst paragraph issimilar to theprimary predicateIndications for Use.Language specific tovalidated millingcenter has beenadded, identical tothe reference deviceused for thistechnology(K183138).Additionally,language specific tothe placement oflarge diameterimplant bodies hasbeen added,identical to thereference deviceused for thistechnology(K071161) |
| System: | K3Pro® Konus New Abutments andImplants | K3Pro® KonusAdditional Abutmentsand Implants(Primary Predicate) | NSI Endosseous Dental Implants | Similarities and Differences | |
| 510(k) number | Subject Device | K160581Primary Predicate | K071161Reference Device | N/A | |
| Material ofManufacture | Grade 4 Ti (commercially puretitanium) | Grade 4 Ti (commercially puretitanium) | Grade 4 Ti (commercially puretitanium) | Same as implants in Primary andReference Devices (K160581 andK071161) | |
| Implant Surface | OsteoActive® Surface | OsteoActive® Surface | SInergy™ Surface | Same as Primary Predicate K160581 | |
| Implant BodyDiameter | 7.0, 8.0mm | 4.0, 4.5, 5.0, 6.0mm | 8.0, 9.0mm | Different from Primary Predicate(K160581)Within Reference Device availablediameters (K071161). Subject deviceproposes a smaller diameter than theReference Device, which does notimpact substantial equivalence. | |
| ImplantBody 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 withinrange of Primary Predicate (K160581)and 9.0 and 11.0mm length are withinrange of Reference Device (K071161) | |
| Implant Platform | 3mm | 3mm | Not publicly available | Same as Primary Predicate K160581 | |
| ImplantConnection toAbutment | Internal Hex alignment, 1.5° lockingconical taper, screw attachment orcement | Internal Hex alignment, 1.5° lockingconical taper, screw attachment orcement | Internal Tri-lobe hex connection(TRI-NEX®), screw attachment orcement | Same as Primary Predicate K160581 | |
| System: | K3Pro® Konus New Abutmentsand Implants | K3Pro® KonusAdditionalAbutments and Implants -K3Pro® CAD Blanks and UNI.CADBlanks(Primary Predicate) | Certain BellaTek® Express andBellaTek® Flex Abutments(Reference Device) | Similarities and Differences | |
| 510(k) number | Subject Device | K160581Primary Predicate | K183138Reference Device | N/A | |
| Material ofManufacture | Grade 5 Ti-6Al 4V-ELI andZirconia | Grade 5 Ti-6Al 4V-ELI | Grade 5 Ti-6Al 4V-ELI and Zirconia | Similar to Primary Predicate(K160581) with the addition ofthe zirconia and Same asReference Device (K183138) | |
| Abutment Type | Two-Piece/Ti-Base | Blank-Type | Two-Piece/Ti-Base | Different from Primary Predicate(K160581). Same as ReferenceDevice (K183138) | |
| Abutment Diameter | 4.0mm | 10.0mm and 16.0mm | 3.4, 4.1, 5.0 and 6.0mm | Different from Primary Predicate(K160581). Within range ofReference Device (K183138) | |
| Abutment Post Height | 4.0 - 14.2mm | 4.0 - 14.2mm | 4.7 – 12.0mm | Same as Primary PredicateK160581 | |
| Connection to Abutment | Hex alignment, 1.5° lockingconical taper, screw attachmentor cement | Hex alignment, 1.5° lockingconical taper, screw attachmentor cement | Biomet 3i Internal Hex Implants,screw or cement retained | Same as Primary PredicateK160581 | |
| Implant/AbutmentConnection | K3Pro® Implants 2.0 and 3.0mminternal connection | K3Pro® Implants 2.0 and 3.0mminternal connection | Biomet 3i Internal Hex Implants | Same as Primary PredicateK160581 | |
| Range of AbutmentGingival Height | 0.5 - 1.5mm | 0.5 - 2.5mm | 0.25 – 6mm | Within range of Primary PredicateK160581 | |
| Range of AbutmentAngulation | 0° - Zirconia coping can be angledup to 30° | 0 - 30° | 0° | Within range of Primary PredicateK160581 | |
| System: | K3Pro® Konus New Abutmentsand Implants | K3Pro® KonusAdditionalAbutments and Implants -K3Pro® CAD Blanks and UNI.CADBlanks(Primary Predicate) | Certain BellaTek® Express andBellaTek® Flex Abutments(Reference Device) | Similarities and Differences | |
| 510(k) number | Subject Device | K160581Primary Predicate | K183138Reference Device | N/A | |
| Material ofManufacture | Grade 5 Ti-6Al 4V-ELI andZirconia | Grade 5 Ti-6Al 4V- ELI | Grade 5 Ti-6Al 4V-ELI and Zirconia | Similar to Primary Predicate(160581) with the addition of thezirconia and Same as ReferenceDevice (K183138) | |
| Abutment Type | Two-Piece/Ti-Base | Blank-Type | Two-Piece/Ti-Base | Different from Primary Predicate(K160581). Same as ReferenceDevice (K183138) | |
| Abutment Diameter | 4.0mm | 10.0mm and 16.0mm | 3.4, 4.1, 5.0 and 6.0mm | Different from Primary Predicate(K160581). Within range ofReference Device (K183138) | |
| Abutment Post Height | 4.0 – 14.2mm | 4.0 – 14.2mm | 4.7 – 12.0mm | Same as Primary PredicateK160581 | |
| Connection to Abutment | Hex alignment, 1.5° lockingconical taper, screw attachmentor cement | Hex alignment, 1.5° lockingconical taper, screw attachmentor cement | Biomet 3i Internal Hex Implants,screw or cement retained | Same as Primary PredicateK160581 | |
| Implant/AbutmentConnection | K3Pro® Implants 2.0 and 3.0mminternal connection | K3Pro® Implants 2.0 and 3.0mminternal connection | Biomet 3i Internal Hex Implants | Same as Primary PredicateK160581 | |
| Range of AbutmentGingival Height | 0.5 - 1.5mm | 0.5 – 2.5mm | 0.25 - 6mm | Within range of Primary PredicateK160581 | |
| Range of AbutmentAngulation | 0° | 0 - 30° | 0° | Same as Reference Device(K183138) | |
| System: | K3Pro® Konus New Abutmentsand Implants | K3Pro® Konus AdditionalAbutments and Implants -K3Pro® CAD Blanks and UNI.CADBlanks(Primary Predicate) | Certain BellaTek® Express andBellaTek® Flex Abutments(Reference Device) | Similarities and Differences | |
| 510(k) number | Subject Device | K160581Primary Predicate | K183138Reference Device | N/A | |
| Material ofManufacture | Grade 5 Ti-6Al 4V-ELI andZirconia | Grade 5 Ti-6Al 4V-ELI | Grade 5 Ti-6Al 4V-ELI and Zirconia | Similar to Primary Predicate(160581) with the addition of thezirconia and Same as ReferenceDevice (K183138) | |
| Abutment Type | Two-Piece/Ti-Base | Blank-Type | Two-Piece/Ti-Base | Different from Primary Predicate(K160581). Same as ReferenceDevice (K183138) | |
| Abutment Diameter | 4.0mm and 5.0mm | 10.0mm and 16.0mm | 3.4, 4.1, 5.0 and 6.0mm | Different from Primary Predicate(K160581). Within range ofReference Device (K183138) | |
| Abutment Post Height | 4.0 – 14.2mm | 4.0 – 14.2mm | 4.7 – 12.0mm | Same as Primary PredicateK160581 | |
| Connection to Abutment | Hex alignment, 1.5° lockingconical taper, screw attachmentor cement | Hex alignment, 1.5° lockingconical taper, screw attachmentor cement | Biomet 3i Internal Hex Implants,screw or cement retained | Same as Primary PredicateK160581 | |
| Implant/AbutmentConnection | K3Pro® Implants 2.0 and 3.0mminternal connection | K3Pro® Implants 2.0 and 3.0mminternal connection | Biomet 3i Internal Hex Implants | Same as Primary PredicateK160581 | |
| Range of AbutmentGingival Height | 0.5 - 2.5mm | 0.5 - 2.5mm | 0.25 - 6mm | Same as Primary PredicateK160581 | |
| Range of AbutmentAngulation | 0 – 20° | 0 - 30° | 0° | Within range of Primary PredicateK160581 | |
| System: | K3Pro® Konus New Abutmentsand Implants | K3Pro® KonusAdditionalAbutments and Implants -K3Pro® CAD Blanks and UNI.CADBlanks(Primary Predicate) | Certain BellaTek® Express andBellaTek® Flex Abutments(Reference Device) | Similarities and Differences | |
| 510(k) number | Subject Device | K160581Primary Predicate | K183138Reference Device | N/A | |
| Material ofManufacture | Grade 5 Ti-6Al 4V-ELI andZirconia | Grade 5 Ti-6Al 4V-ELI | Grade 5 Ti-6Al 4V-ELI and Zirconia | Similar to Primary Predicate(160581) with the addition of thezirconia and Same as ReferenceDevice (K183138) | |
| Abutment Type | Two-Piece/Ti-Base | Blank-Type | Two-Piece/Ti-Base | Different from Primary Predicate(K160581). Same as ReferenceDevice (K183138) | |
| Abutment Diameter | 4.0mm and 4.5mm | 10.0mm and 16.0mm | 3.4, 4.1, 5.0 and 6.0mm | Different from Primary Predicate(K160581). Within range ofReference Device (K183138) | |
| Abutment Post Height | 4.0 - 14.2mm | 4.0 - 14.2mm | 4.7 – 12.0mm | Same as Primary PredicateK160581 | |
| Connection to Abutment | Hex alignment, 1.5° lockingconical taper, screw attachmentor cement | Hex alignment, 1.5° lockingconical taper, screw attachmentor cement | Biomet 3i Internal Hex Implants,screw or cement retained | Same as Primary PredicateK160581 | |
| Implant/AbutmentConnection | K3Pro® Implants 2.0 and 3.0mminternal connection | K3Pro® Implants 2.0 and 3.0mminternal connection | Biomet 3i Internal Hex Implants | Same as Primary PredicateK160581 | |
| Range of AbutmentGingival Height | 0.5 - 1.5mm | 0.5 – 2.5mm | 0.25 - 6mm | Within range of Primary PredicateK160581 | |
| Range of AbutmentAngulation | 0° | 0 - 30° | 0° | Within range of Primary PredicateK160581 |
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Image /page/8/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 "3" in red and the "K" and "Pro" in gray. The text "KONUS DENTAL IMPLANTS" is written in a smaller font below the main logo. The logo is simple and modern, with a focus on the company name and its dental implant products.
Image /page/8/Picture/2 description: The image shows the logo for Argon Medical Devices & Dental Implants. The logo is red and features the word "Argon" in large, bold letters. Below the word "Argon" is the phrase "MEDICAL DEVICES & DENTAL IMPLANTS" in smaller letters. There is a red curved line above the word "Argon".
Comparison of TECHNOLOGICAL CHARACTERISTICS – Subject Device – Implants
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Image /page/9/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. Above the text is a registered trademark symbol. Below the text is the phrase "KONUS DENTAL IMPLANTS" in a smaller, sans-serif font.
Image /page/9/Picture/2 description: The image shows the logo for Argon Medical Devices & Dental Implants. The logo is red and features the word "Argon" in a bold, sans-serif font. Below the word "Argon" is the text "MEDICAL DEVICES & DENTAL IMPLANTS" in a smaller font. A red curved line is above the word "Argon".
Comparison of TECHNOLOGICAL CHARACTERISTICS – Subject Device – Ti-Base Abutments – CG.C
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Image /page/10/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. Above the text is a registered trademark symbol. Below the text is the phrase "KONUS DENTAL IMPLANTS" in a smaller, sans-serif font.
Image /page/10/Picture/2 description: The image shows the logo for Argon Medical Devices & Dental Implants. The word "Argon" is written in large, red letters. Below the word "Argon" is the phrase "MEDICAL DEVICES & DENTAL IMPLANTS" in smaller, black letters. A red curved line is above the word "Argon".
Comparison of TECHNOLOGICAL CHARACTERISTICS – Subject Device – Ti-Base Abutments – CG.V
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Image /page/11/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. Above the text is a registered trademark symbol. Below the text is the phrase "KONUS DENTAL IMPLANTS" in a smaller, sans-serif font.
Image /page/11/Picture/2 description: The image is a logo for Argon Medical Devices & Dental Implants. The word "Argon" is in large, red, bold letters. Below the word "Argon" is the phrase "MEDICAL DEVICES & DENTAL IMPLANTS" in smaller, red letters. A red arc is above the word "Argon".
Comparison of TECHNOLOGICAL CHARACTERISTICS – Subject Device – Ti-Base Abutments – KSA
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Image /page/12/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" in gray and the "pro" in red. Below the text "K3pro" is the text "KONUS DENTAL IMPLANTS" in a smaller, sans-serif font. The logo is simple and modern, and it is likely used to promote a dental implant company.
Image /page/12/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, black letters. A red swoosh design is above the word "Argon".
Comparison of TECHNOLOGICAL CHARACTERISTICS – Subject Device – Ti-Base Abutments – CS
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Image /page/13/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" in red and the "pro" in gray. Below the text is the phrase "KONUS DENTAL IMPLANTS" in a smaller font, set against a red background. The logo is clean and modern, with a focus on the brand name and the type of product offered.
Image /page/13/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, black letters. A red curved line is above the word "Argon".
Summary of Technological Characteristics: The physical properties and designs of the K3Pro® Konus Nere compared to legally marketed predicate devices. The technological characteristics were comparable.
The abutnents are Ttanium-base type abutments to be used of two-piece abutment same as reference device Certain BellaTel® Express and BellaTek® Plex Abutments (K183138). They are available in both 2 and 3mm platform diameters (same as Primary Predicate K160581). The subject abutments are designed to only mate with the inplants (K141159) and K3Pro® Konus Additional Abutnents and Implants (K16058) previously cleared and the implants bodies in this submission (same as the abutments included in the Primary Predicate submission (K160185).
The subject device and the predicate devices have similar instruction and surface treatment, incorporate the same materials and design, are packaged and sterilized using the same materials and processes.
Substantial Equivalence Discussion: The cimilarties between the predicate and proposed devices. Argon has presented comparative data in the preceding paragrate that the K3Pro® New Abutments and Implants are substantially equivalent to the predicate devices. Any differences between the proposed device do not impact substantial equivalence.
Non-Clinical Testing: Non-clinical data submitted, or relied upon to demonstrate substantial equivalence include:
- -Gamma sterilization validation according to ISO 11137-3 (conducted on the proposed implants);
- -Steam sterilization validation according to ISO 11138-3.2006 779 | freferenced from K141159 for proposed implants and conducted on the proposed abutments);
- Drying time validation according to ANSI/AAMI ST79:2010 & A1:2010 (conducted on proposed abutments);
- Pyrogenicity information according to FDA Guidance, "Submission in Premarket Notification (510 (k) Submissions । for Devices Labeled as Sterile: LAL endotoxin test according to USP [85] (conducted on the proposed implants);
- Biocompatibility assessment according to ISO 1099-1 and cytotoxicity to ISO 1099-5 ] (conducted on the proposed implants and abutments);
- Fotique testing according to ISO 14801 and FDA Special Controls Guidance Document Root-form Endosseous Dental -Implant Abutments (conducted on proposed abutments).
- Shelf Life of Implant Bodies in this submission have the identical packaging to the implants cleared under primary predicate K160581. - Additionally, the subject implants are currently under testing for Validation of Claimed Shef Life acording to ASTM F 1886. The current results have been provided for review.
No animal testing or human clinical trials have been conducted.
Surface area analysis of the submission device was previously established in the review of K141159.
Conclusion: The subject device and the predication for use, similar technological characteristics, and are made of similar if not identical materials; the non-clinical performance to the predicates listed. The subject and predicate devices encompass similar physical dimensions, including diameter, length and subject and predicate devices are packaged in comparable materials. The implants are provided sterile, and the abut mith equivalent methods. The data provided in this submission supports he finding of the K3Pro® New Abutments and Implants to be substantially equivalent to the predicate devices referenced above.
§ 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.