PYRAMIDION Dental Implants and Prostheses

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logos of the U.S. 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 includes the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. December 13, 2018 DenTack Implants Ltd % Tali Hazan Regulatory Consultant Talmed Ltd. M.P Upper Galillee Ramot Naftali, 13830 ISRAEL Re: K180859 Trade/Device Name: PYRAMIDION Dental Implants and Prostheses Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: November 1, 2018 Received: November 13, 2018 Dear Tali Hazan: 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, # Andrew I. Steen -S for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K180859 Device Name PYRAMIDION Dental Implants and Prostheses Indications for Use (Describe) DenTack PYRAMIDION Dental Implants and Prostheses are intended for surgical placement in the maxilla and/or in the mandible to provide a means for prosthetic attachment in single tooth restorations and in partially or fully edentulous jaws utilizing conventional, delayed or immediate loading when good primary stability is achieved and with appropriate occlusal loading. Implants in 5-6mm length are indicated for delayed loading only. Type of Use (Select one or both, as applicable) | <span style="font-size:100%;">☒</span> Prescription Use (Part 21 CFR 801 Subpart D) | |-------------------------------------------------------------------------------------| | <span style="font-size:100%;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) | ## 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 shows the logo for Paramidion Implant Solutions. The word "PARAMIDION" is written in blue, with a stylized "lambda" symbol replacing the "A". Below the main word, in a smaller, gray font, are the words "Implant Solutions." # 510(K) SUMMARY FOR DENTACK'S PYRAMIDION - DENTAL IMPLANTS AND PROSTHESES - ## DATE PREPARED: DECEMBER 13, 2018 ## 1. 510(K) OWNER NAME DenTack Implants Ltd 24 HaTa'as St. POB 2405 Kfar-Saba 4464102 Israel Phone: +972-9-7660379, Fax: +972-9-7738280, Email: info@dentack.com. ## Contact person name: Ms. Tali Hazan - RA Consultant Phone: +972-(0)50-5292-304 Fax: +972-(0)722448981 Email: tali.hazan@talmed.co.il ## 2. DEVICE NAME AND CLASSIFICATION Common/Usual Name: Dental Implants and Prostheses Proprietary/Trade name: PYRAMIDION Dental Implants and Prostheses Classification: DenTack's PYRAMIDION device has been classified as Class II device under the following classification names: | Classification Name | Product Code | 21 CFR Ref. | Panel | |---------------------------|--------------------------------|-------------|--------| | Endosseous dental implant | Primary: DZE<br>Secondary: NHA | 872.3640 | Dental | {4}------------------------------------------------ ## 3. PREDICATE DEVICES DenTack's PYRAMIDION Dental Implants and Prostheses are substantially equivalent to the following Predicate Devices: - 3.1 Primary Predicate Device: DenTack's OUAD Dental Implants and Prostheses, cleared under 510(k) number K152188 on January 28, 2016. - 3.2 Reference Device: Biomet's Biomet 3i T3 Dental Abutments, cleared under 510(k) K072642 on December 20, 2007. - 3.3 Reference Device: Bicon's Bicon Implants with A 2.5mm Internal Connection cleared under 510(k) K092035 on October 15, 2009. - 3.4 Reference Device: Biomet's Biomet 3i T3 Short implant, cleared under 510(k) K150571 on November 20, 2015. - 3.5 Reference Device: Quantum BioEngineering Ltd's Quantum™ Dental Implant System, cleared under 510(k) K112279 on May 01, 2012. ## DEVICE DESCRIPTION 4. DenTack has developed a range of expandable dental implants made of titanium (the most common material for dental implants) to serve the need of patients that require partial or complete tooth restoration. The implant is placed so its end is in the trabecular (spongy) bone like any other implant. Once in place, the apical portion of the implant is expanded to achieve increased contact surface area with the surrounding bone. The system also includes various accessories that are attached to the implant. The PYRAMIDION has an external hex connection with 0.7mm height and 2.7mm hex with a distinct projection externally to the implant body. The connection between the prosthetic part to the upper platform of the implant interacts with a recessed plain of 15-degrees into the upper platform of the implant body while it is projected from the prosthetic part. {5}------------------------------------------------ All DenTack's implants are made of biocompatible Titanium. Prostheses and Surgical components are made of same Titanium alloy, stainless-steel and polymers. DenTack's PYRAMIDION Implants with are the subject of this submission are available in outer diameter (OD) of 4.1 mm and in length of 5 and 6 mm. DenTack's Prostheses and dimension ranges are identified as follows: | Metal Housing | 3.3 mm Height | |------------------------------------------------------------|----------------------------| | Plastic Cup | 2.7 mm Height | | Straight Multi-Unit Sleeve | 11 mm Height | | Straight Multi-Unit Screw | 2.3 mm Diameter | | Angled Abutments 15° And 22.5° | Length: 7 mm – 9 mm | | Angled Abutments 15° Large | Total Length: 9 mm – 12 mm | | Ball Attachments | 2, 3 and 4 mm Height | | Direct Screw Platform | | | Straight Abutments 2, 3, 8.5 mm<br>Length | | | Straight Multi-Unit Abutments 2, 3<br>and 4 mm Length | | | Angled Multi Unit Abutments 17°<br>and 1.5 and 3 mm Length | | | Healing Caps 3, 4, 5 and 6 mm | | Cover Screw The Direct Screw Platform is to be used with a burn-out plastic sleeve for ensuring a minimum post height of 4 mm (with no angular correction). Like the QUAD implants cleared under K152188, the subject PYRAMIDION implants expansion is performed using a reusable Expansion Tool and Ratchet Torque). ……………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………… {6}------------------------------------------------ ## 5. INTENDED USE DenTack PYRAMIDION Dental Implants and Prostheses are intended for surgical placement in the maxilla and/or in the mandible to provide a means for prosthetic attachment in single tooth restorations and in partially or fully edentulous jaws utilizing conventional, delayed or immediate loading when good primary stability is achieved and with appropriate occlusal loading. Implants in 5-6mm length are indicated for delayed loading only. ## PERFORMANCE DATA 6. A series of safety and performance tests and evaluations were performed to demonstrate that DenTack's PYRAMIDION Dental Implant System does not raise any new issues of safety and effectiveness to support substantial equivalence with the predicate devices. These evaluations include are: - a) Fatigue Test This test was conducted according to ISO 14801 standard for Dentistry -Implants - Dynamic fatigue test for endosseous dental implants and with accordance to FDA Guidance for Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments, dated: May 12, 2004. Worst case configuration was selected to reflect the most challenging situation for the implant and abutment. - b) Surface analysis The implant surface after surface treatment was tested using the SEM (Scanning Electron Microscope) which is a valid, conventional and known method. - c) Implant Removal after Expansion This comparative test was conducted per DenTack protocol, in order to demonstrate that the expandable design does not cause additional damage to the surrounding tissue. {7}------------------------------------------------ For the purpose of this test artificial bone was used and a reference legally marketed device for comparison. Both implants were "implanted" in the artificial bone and removed per instructions for use. The evaluation post implant removal showed that both implants performed equally in terms of interaction with the bone. - d) Evaluation of Minimal Rotation Torque after Placement and Expansion -The test was conducted per DenTack protocol, in order to evaluate the minimal rotation torque after OUAD placement and expansion in the artificial bone. This evaluation was conducted in comparison to predicate device, simulating the product use per their instructions for use. The tests results found to be very similar and thus equivalent. The OUAD met the acceptance criteria and performed at least as good as or better than the predicate device. ## e) Partially expanded Implant Reciprocating Effect Test - The test was conducted per DenTack protocol, in order to demonstrate that the instructions to counterclockwise and clockwise rotation, when the QUAD only partially expanded, do not cause to an additional damage to the surrounding bone or to the implant. The test was conducted in comparison to a legally marketed device with similar instructions for use (counterclockwise rotation when insufficient insertion occurs). The study demonstrated that both the surrounding bone and the implant were not negatively affected by counterclockwise/clockwise rotation and that the QUAD performed similarly to the reference device. - f) Biocompatibility Biocompatibility was evaluated with accordance to ISO 10993-1 standard for Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process, considering exhaustive extractions and potential biological (cytotoxic) reaction. The tests were conducted using final and sterilized products with accordance to above mentioned ISO 10993-1 as well as; ISO 10993-5 for Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity and; ISO 10993-12 for Biological evaluation of medical devices - Part 12: Sample preparation and …………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………… December 13, 2018 {8}------------------------------------------------ reference materials. The chemical and biological tests have not revealed any incompatibility potential or any adverse effect. Endotoxin testing (LAL test method) conducted per USP <85> to show endotoxins are within acceptable criteria (i.e., not more than 20EU/Device or 0.5EU/mL). - g) Gamma Sterilization Validation Sterilization was conducted with successful results, using Gamma Irradiation according to VDmax method in accordance with ISO 11137-2 for Sterilization of health care products – Radiation - Part 2: Establishing the sterilization dose, and in conjunction with AAMI TIR 33 (recently replaced by ISO/TS 13004). - h) Steam Sterilization Validation Was performed to validate the instructions for steam sterilization provided by DenTack for prosthetic parts that are provided non-sterile and are to be steam sterilized by the user at the clinic. The validation was conducted with accordance to ISO 17665-1:2006, ANSI AAMI ST79:2010 and ANSI AAMI ST77:2013. The validation results supported SAL 10-6. IFU (instructions for use) are in-line with the validation results. - i) Cleaning Validation This test was conducted in order to evaluate the cleaning effectiveness before each reuse of reusable tools. The validation was conducted per AAMI TIR 30 standard with successful results. - j) Shelf life validation Was performed with accordance to ISO 11607-1 for Packaging for Terminally Sterilized Medical Devices – Part 1: Requirements for Materials, Sterile Barrier Systems and Packaging Systems. This validation confirmed that the sterility of DenTack's sterile products will be remained for the device shelf life. - k) Comparative Pull-out Test The test was performed according to the requirements of ASTM F543 Standard Specification and Test Methods for Metallic Medical Bone Screws in comparison with legally marketed device. {9}------------------------------------------------ - I) Comparative Bone to Implant Contact Surface Area Analysis - Contact surface area was analyzed in comparison to legally marketed device at worst case implant variation. - m) Implant Surface Area Analysis Implant actual surface area before surface treatment was compared to legally marketed device at worst case implant variation. All results support DenTack's labeling claims in order to establish substantial equivalency with the selected predicate devices. ## 7. TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE DenTack Implants are manufactured from biocompatible Titanium 6Al-4V-ELI and Pure Titanium. Implant surface is treated by an established Titanium blasting method. Restorative components are manufactured with common titanium alloy, stainless-steel and polymers. The proposed DenTack's Dental Implant System has similar indications for use, technological characteristics, mode of operation and, performance specification as the above identified predicate devices. The proposed device utilizes same intended use as the predicate devices and shares same methodology as the predicate devices. Both the proposed and predicate devices function in the same manner providing support for prosthetic devices in the upper or lower jaw. With the exception of the lengths and connection platform DenTack's previously cleared OUAD (K152188) and PYRAMIDION implants are identical. These differences were bridged by reference devices and performance testing. Therefore, it was concluded that they are substantially equivalent. The comparison of the similarities and differences between PYRAMIDION implant and predicate devices are hereby presented in the tables as follows: {10}------------------------------------------------ # PARAMIDION Implant Solutions | Implant<br>Feature | - Primary Predicate<br>Device -<br>DenTack's QUAD<br>Implant cleared under<br>510(k) K152188 | - Reference Device -<br>Bicon Implants<br>cleared under<br>510(k) K092035 | - Reference Device -<br>Biomet's<br>3i T3 short implant<br>cleared under 510(k)<br>K150571 | - Reference Device -<br>Quantum's dental<br>implant system<br>Cleared under 510(k)<br>K112279 | - New Device -<br>DenTack's<br>PYRAMIDION | |------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended | DenTack Dental | The Bicon implant is | The 3i T3® Short<br>Implants are intended | Quantum™, Dental<br>Implant System implants | DenTack | | Use | Implants and Prostheses<br>are intended for<br>surgical placement in<br>the maxilla and/or in<br>the mandible to provide<br>a means for prosthetic<br>attachment in single<br>tooth restorations and in<br>partially or fully<br>edentulous jaws<br>utilizing conventional,<br>delayed or immediate<br>loading; when good<br>primary stability is<br>achieved. | designed for use in<br>edentulous sites in<br>the mandible or<br>maxilla for support<br>of a complete<br>denture prosthesis, a<br>final or intermediate<br>abutment for fixed<br>bridgework or for<br>partial dentures, or<br>as a single tooth<br>replacement. | for surgical placement<br>in the upper or lower<br>jaw to provide a<br>means for prosthetic<br>attachment in single<br>tooth restorations and<br>in partially or fully<br>edentulous spans with<br>multiple single teeth<br>utilizing delayed<br>loading, or with a<br>terminal or<br>intermediary abutment<br>for fixed or removable<br>bridgework, and to<br>retain overdentures. | are intended for immediate<br>or delayed placement in<br>the bone of the maxillary<br>or mandibular arch.<br>Quantum Dental Implant<br>System abutments are<br>intended for use as support<br>for crowns, bridges or<br>overdentures. When a one-<br>stage surgical approach is<br>applied, threaded implant<br>may be immediately<br>loaded when good primary<br>stability is achieved and<br>the functional load is<br>appropriate. Delayed<br>loading is required when<br>using the push-in<br>technique for fin-type or<br>threaded implants, or when<br>using any 5mm or 6mm<br>length implant. | PYRAMIDION Dental<br>Implants and Prostheses<br>are intended for surgical<br>placement in the maxilla<br>and/or in the mandible<br>to provide a means for<br>prosthetic attachment in<br>single tooth restorations<br>and in partially or fully<br>edentulous jaws<br>utilizing conventional,<br>delayed or immediate<br>loading when good<br>primary stability is<br>achieved and with<br>appropriate occlusal<br>loading. Implants in<br>5-6mm length are<br>indicated for delayed<br>loading only. | | Implant<br>Feature | - Primary Predicate<br>Device -<br>DenTack's QUAD<br>Implant cleared under<br>510(k) K152188 | - Reference Device -<br>Bicon Implants<br>cleared under<br>510(k) K092035 | - Reference Device -<br>Biomet's<br>3i T3 short implant<br>cleared under 510(k)<br>K150571 | - Reference Device -<br>Quantum's dental<br>implant system<br>Cleared under 510(k)<br>K112279 | - New Device -<br>DenTack's<br>PYRAMIDION | | Patient<br>Population | Edentulous or partially<br>Edentulous individuals | Edentulous or<br>partially Edentulous<br>individuals | Edentulous or<br>partially Edentulous<br>individuals | Edentulous or partially<br>Edentulous individuals | Edentulous or partially<br>Edentulous individuals | | Material | Implant body: Titanium<br>alloy ELI,<br>Implant foils: Pure<br>Titanium, unalloyed. | Titanium alloy ELI | Pure titanium | Titanium alloy | Implant body: Titanium<br>alloy ELI,<br>Implant foils: Pure<br>Titanium, unalloyed. | | Implant<br>Model | DenTack<br>PYRAMIDION<br>expandable dental<br>implants for<br>conventional, delayed<br>or immediate load<br>(7-11mm length<br>implants). | Non-expandable<br>short implants (5mm<br>length), not for<br>immediate loading. | Non-expandable, short<br>implants (5-6mm<br>length) not for<br>immediate loading. | Non-expandable, short<br>implants (5-6mm length)<br>not for immediate loading. | Expandable dental<br>implants in 5-6mm<br>length implants, not for<br>immediate loading but<br>for delayed load only. | | Implant<br>Dimensions | Length (mm): 7, 8, 9,<br>10 and 11<br>Diameter (mm): 3.75,<br>4.1 | Length (mm): 5<br>Diameter (mm): 4 | Length (mm): 5, 6<br>Diameter (mm): 5, 6 | Length (mm): 5, 6<br>Diameter (mm): 4 | Length (mm): 5, 6<br>Diameter (mm): 4.1 | | Surface | Titanium Oxide<br>Blasting and acid<br>etching | Hydroxylapatite<br>(HA) | The implants are<br>offered with or<br>without a nano-scale<br>discrete crystalline<br>deposition (DCD®)<br>calcium phosphate | RBM,<br>Acid etch,<br>HA coated | Titanium Oxide<br>Blasting and acid<br>etching | | Implant<br>Feature | - Primary Predicate<br>Device -<br>DenTack's QUAD<br>Implant cleared under<br>510(k) K152188 | - Reference Device -<br>Bicon Implants<br>cleared under<br>510(k) K092035 | - Reference Device -<br>Biomet's<br>3i T3 short implant<br>cleared under 510(k)<br>K150571 | - Reference Device -<br>Quantum's dental<br>implant system<br>Cleared under 510(k)<br>K112279 | - New Device -<br>DenTack's<br>PYRAMIDION | | | | | (CaP) surface<br>treatment. | | | | Implants<br>Design | Apically expandable<br>root form dental<br>implant. | Cylindrical implant | The dental implants<br>are basic screw-type<br>designs available in<br>parallel walled body<br>geometries with an<br>external hex<br>connection | Threaded and a grooved<br>design | Apically expandable<br>root form dental<br>implant. | | Expansion<br>Mechanism | Expansion tool is<br>inserted in the implant<br>upper platform and<br>implant is expanded<br>using the ratchet torque. | No expansion<br>mechanism | No expansion<br>mechanism | No expansion mechanism | Expansion tool is<br>inserted in the implant<br>upper platform and<br>implant is expanded<br>using the ratchet torque. | | Sterility | Sterile by Gamma<br>Irradiation | Sterile | Sterile | Sterile | Sterile by Gamma<br>Irradiation | | Placement<br>method | Placing the implant<br>immediately after<br>drilling | Placing the implant<br>immediately after<br>drilling by tapping it | Placing the implant<br>immediately after<br>drilling | Placing the implant<br>immediately after drilling | Placing the implant<br>immediately after<br>drilling | | Self-<br>Tapping | Yes | No | Yes | Yes | Yes | | Connection<br>type | Internal hex | Internal Hex | External Hex | Internal and External Hex | External hex | | Implant<br>Feature | - Primary Predicate<br>Device -<br>DenTack's QUAD<br>Implant cleared under<br>510(k) K152188 | - Reference Device -<br>Bicon Implants<br>cleared under<br>510(k) K092035 | - Reference Device -<br>Biomet's<br>3i T3 short implant<br>cleared under 510(k)<br>K150571 | - Reference Device -<br>Quantum's dental<br>implant system<br>Cleared under 510(k)<br>K112279 | - New Device -<br>DenTack's<br>PYRAMIDION | | Maximum<br>abutment<br>angle | 25° | 0° (straight) | 30° | Up to 25° | 22.5° | .............................................................................................................................................................................. .............................................................................................................................................................................. {11}------------------------------------------------ # PARAMIDION # Implant Solutions {12}------------------------------------------------ # PARAMIDION Implant Solutions {13}------------------------------------------------ # PARAMIDION Implant Solutions {14}------------------------------------------------ The comparison of the similarities and differences between PYRAMIDION Prostheses and predicate device are hereby presented in the tables below: | Abutment<br>Feature | - Reference Device -<br>Biomet's 3i T3 Dental Abutments<br>cleared under 510(k) K072642 | - New Device -<br>DenTack's PYRAMIDION | |-----------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use | BIOMET <i>3i</i> Dental Abutments are<br>intended<br>for use as accessories to endosseous<br>dental implant to support a prosthetic<br>device in a partially or completely<br>edentulous patient. A dental abutment<br>is intended for use to support single and<br>multiple tooth prosthesis, in the<br>mandible or maxilla. The prosthesis<br>can be screw retained or cement<br>retained.<br>Restorative Components:<br>• Temporary Healing Abutments are<br>intended for use to shape and<br>maintain the soft tissue opening<br>during healing.<br>• Castable restorative components<br>are intended for use as accessories<br>to endosseous dental implants to<br>aid in the fabrication of dental<br>prosthetics.<br>• Screw components are intended for<br>use as accessories to endosseous<br>dental implants for retention of<br>screw retained abutments to the<br>dental implant. | Same intended use and clinical<br>purpose. | | Abutment<br>Feature | - Reference Device -<br>Biomet's 3i T3 Dental Abutments<br>cleared under 510(k) K072642 | - New Device -<br>DenTack's PYRAMIDION | | Items<br>Identification<br>and<br>Description | PAP452G, Angled abutment total<br>length 9 mm 15° angle | Angled Abutment total length 9 mm<br>15° angle | | | PAP452G, Angled abutment total<br>length 9 mm 15° angle | Angled Abutment total length 12 mm<br>15° angle | | | IPAP462G, Angled Abutment (AA) 8<br>mm length 15° angle. | Angled Abutment 7.0 mm length<br>22.5° angle | | | PAP452G, Angled Abutment total<br>length 9 mm 15° angle. | Angled Abutment total length 9 mm<br>22.5° angle | | | LOA002, Titanium alloy removable<br>overdentures 2 mm height | Ball attachment abutment 2 mm<br>height | | | LOA003, Titanium alloy removable<br>overdentures 3 mm height | Ball attachment abutment 3 mm<br>height | | | LOA004, Titanium alloy removable<br>overdentures 4 mm height | Ball attachment abutment 4 mm<br>height | | | LAIC1, Overdenture metal housing | Metal housing 3.3 mm height.<br>*Made of SS | | | LAERM, Extended range males | Plastic cup 2.7 mm height.<br>*Made of Plastic (Nylon) | | | UNAB2C, Direct Screw Platform 11.0<br>mm height. | Direct Screw Platform<br>*to be used with burn-out plastic sleeve<br>ensuring a minimum post-height of 4mm<br>(with no angular correction) | | | APP452G, Straight Abutment vary<br>according to gingival height | Straight abutment 2, 3, 8.5 mm<br>length - Similar to Biomet part<br>presented for DenTack's SA-xxxEX,<br>dimensions | | | APP452G straight abutment 2 mm<br>length (One representative model<br>among others that vary in gingival<br>height) | Straight abutment 2, 3 and 8.5 mm<br>length | | | Straight Multi-unit abutments 2 mm<br>length LPC442U (One representative | Straight Multi-unit abutments 2, 3<br>and 4 mm length | | Abutment<br>Feature…