Inclusive® Titanium Abutments compatible with: Neoss® ProActive® Narrow, Neoss® ProActive® Standard, MIS® SEVEN®, Zimmer® Eztetic® Implant Systems

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. Prismatik Dentalcraft, Inc. So Park Regulatory Affairs Manager 2144 Michelson Drive Irvine, California 92612 # Re: K231097 Trade/Device Name: Inclusive® Titanium Abutments compatible with: Neoss® ProActive® Narrow, Neoss® ProActive® Standard, MIS® SEVEN®, Zimmer® Eztetic® Implant Systems Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: October 13, 2023 Received: October 13, 2023 # Dear So Park: We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. {1}------------------------------------------------ If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product: and 21 CFR 820.100. Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. {2}------------------------------------------------ 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, # Andrew I. Steen -S Andrew I. Steen Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ # Indications for Use 510(k) Number (if known) K231097 ### Device Name Inclusive® Titanium Abutments compatible with: Neoss® ProActive® Narrow, Neoss® ProActive® Standard, MIS® SEVEN®, Zimmer® Eztetic® Implant Systems ### Indications for Use (Describe) Inclusive® Titanium Abutments are premanufactured prosthetic components connected to endosseous dental implants in edentulous or partially edentulous maxilla or mandible to provide support for cement-retained prosthetic restorations. All digitally designed abutments for use with Inclusive® Titanium Abutments for CAD/CAM are intended to be sent to a Prismatik Dentalcraft validated milling center for manufacture. Compatible Implant System: Neoss® ProActive® Narrow, Neoss® ProActive® Standard, MIS® SEVEN®, Zimmer® Eztetic® | Compatible Implant Fixtures | Implant Body Diameter | Implant Platform Diameter | |-----------------------------|-----------------------|---------------------------| | Neoss® ProAtive® Narrow | 3.25 mm | Narrow Platform (NP) | | Neoss® ProAtive® Standard | 3.5 mm | Standard Platform (SP) | | | 4.0 mm | | | | 4.5 mm | | | | 5.0 mm | | | | 5.5 mm | | | MIS® SEVEN® | 3.3 mm | Narrow Platform (NP) | | | 3.75 mm | Standard Platform (SP) | | | 4.2 mm | | | | 5.0 mm | Wide Platform (WP) | | | 6.0 mm | | | Zimmer® Eztetic® | 3.1 mm | 2.9 mm | | Type of Use (Select one or both, as applicable) | |-------------------------------------------------| |-------------------------------------------------| | <label><input checked="checked" type="checkbox"/> Research Use (Part 21 CFR 201.3 Subpart D)</label> | |------------------------------------------------------------------------------------------------------| | <label><input type="checkbox"/> Over-The-Counter Use (21 CFR 201.3 Subpart C)</label> | > Prescription Use (Part 21 CFR 801 Subpart D) _ Over-The-Counter Use (21 CFR 801 Subpart C) ### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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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." {4}------------------------------------------------ Image /page/4/Picture/0 description: The image contains the logo for Prismatik Dentalcraft, Inc. On the left is a triangle with a gradient of colors, including pink, red, orange, yellow, green, and blue. To the right of the triangle is the text "PRISMATIK DENTALCRAFT, INC" in a blue sans-serif font. The text is arranged in two lines, with "PRISMATIK" on the top line and "DENTALCRAFT, INC" on the bottom line. # 510(k) Summary - K231097 #### I. SUBMITTER Prismatik Dentalcraft, Inc. 2144 Michelson Drive, Irvine, CA 92612, USA Primary Contact Person: So Hyun Park, Regulatory Affairs Manager, MS Email: so.park@glidewelldental.com Phone: (949) 863-5479 Secondary Contact Person: Herbert Crane, VP RA/QA Email: Herbert.crane(@glidewelldental.com Phone: (949) 222-3531 Date Prepared: November 7, 2023 #### II. DEVICE Name of Device: Inclusive® Titanium Abutments compatible with: Neoss® ProActive® Narrow, Neoss® ProActive® Standard, MIS® SEVEN®, Zimmer® Eztetic® Implant Systems Common Name or Usual Name: Dental Implant Abutment Classification Name: Endosseous Dental Implant Abutment (21 CFR 872.3630) Regulatory Class: Class II Product Code: NHA #### III. PREDICATE DEVICE ### Primary Predicate Inclusive® Titanium Abutments compatible with: Dentsply Implants Astra Tech Implant System® EV (K191222) Reference Devices Inclusive® Titanium Abutment Blanks (K083192) Inclusive® Abutments (K160979) Neoss Implant System 3.25 (K090452) Neoss ProActive Implant (K083561) Neoss Access Abutments (K081851) MIS Internal Hex Dental Implant System (K180282) Zimmer 3.1mm Dental Implant; 2.9mm Angled Abutment; Straight Hex, 2.9mm Contour Abutment (K142082) #### IV. DEVICE DESCRIPTION Inclusive® Titanium Abutments are premanufactured prosthetic components {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for PRISMATIK DENTALCRAFT, INC. The logo consists of a triangle on the left side that is filled with a gradient of colors, including blue, pink, and yellow. To the right of the triangle is the text "PRISMATIK DENTALCRAFT, INC." in a sans-serif font. directly connected to endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation. Inclusive® Titanium Abutments are designed and fabricated to be compatible with Neoss® ProActive® Narrow Implant System, Neoss® ProActive® Standard Implant System, MIS® SEVEN® Implant System, and Zimmer® Eztetic® Implant System. The products are made from titanium alloy Ti-6A1-4V ELI, which meets ASTM standard F136. They include Inclusive® Titanium Abutment Blanks intended to be used to fabricate one-piece, all-titanium, patient-specific abutments using CAD/CAM technology and Inclusive® Titanium Abutments 4.5mmH intended to be used for support of fabricated crowns/bridges or a zirconia coping to complete the two-piece abutment. Inclusive® Titanium Abutments are a two-piece abutment with a titanium base and a ceramic top-half which when cemented together (Shofu MonoCem K020481) constitutes the final finished abutment. Each patient-specific abutment is prescribed by a clinician and manufactured by an authorized milling center validated by Prismatik Dentalcraft Inc. Inclusive® Titanium Abutments are provided non-sterile and intended for single use and prescription use. Inclusive® Multi-Unit Coping is manufactured from titanium alloy, Ti-6A1-4V ELI conforming to ASTM F136 and used in conjunction with the Neoss® ProActive® Standard and MIS® SEVEN® multi-unit abutment. Inclusive® Multi-Unit Coping is bonded with the dental restoration prior to being seated on the multi-unit abutment via a multi-unit prosthetic screw. The non-engaging configuration of the multi-unit coping does not have an internal connection feature and seats onto the flat mating surface of the multi-unit abutment. The multi-unit coping is used in combination with screw-retained multi-unit dental prosthetics, e.g. bridges and bars, which are used to reconstruct the function and aesthetics of lost teeth. The multi-unit coping is straight with no angle correction and provided non-sterile. The device is intended for singe use and prescription use. #### V. INDICATIONS FOR USE Inclusive® Titanium Abutments are premanufactured prosthetic components connected to endosseous dental implants in edentulous or partially edentulous maxilla or mandible to provide support for cement-retained or screw-retained prosthetic restorations. All digitally designed abutments for use with Inclusive® Titanium Abutments for CAD/CAM are intended to be sent to a Prismatik Dentalcraft validated milling center for manufacture. | Compatible Implant Fixtures | Implant Body Diameter | Implant Platform Diameter | |-----------------------------|-----------------------|---------------------------| | Neoss® ProActive® Narrow | 3.25 mm | Narrow Platform (NP) | | Neoss® ProActive® Standard | 3.5 mm | Standard Platform (SP) | | | 4.0 mm | | | | 4.5 mm | | | | 5.0 mm | | | | 5.5 mm | | | MIS® SEVEN® | 3.3 mm | Narrow Platform (NP) | Compatible Implant System: Neoss® ProActive® Narrow, Neoss® ProActive® Standard, MIS® SEVEN®, Zimmer® Eztetic® {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for Prismatik Dentalcraft, Inc. The logo consists of a triangle on the left side that is filled with a gradient of colors, including pink, magenta, blue, green, and yellow. To the right of the triangle is the text "PRISMATIK DENTALCRAFT, INC." in a blue sans-serif font. | | 3.75 mm | Standard Platform (SP) | |------------------|---------|------------------------| | | 4.2 mm | | | | 5.0 mm | Wide Platform (WP) | | | 6.0 mm | | | Zimmer® Eztetic® | 3.1 mm | 2.9 mm | {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the logo for Prismatik Dentalcraft, Inc. The logo consists of a colorful triangle on the left and the company name on the right. The triangle is divided into several sections, each with a different color. The company name is written in a sans-serif font, with "PRISMATIK" on the top line and "DENTALCRAFT, INC." on the bottom line. #### COMPARISON OF TECHNOLOGICAL CHARACTERISTICS VI. | Technological<br>Characteristics | Subject Device<br>(K231097) | Predicate Device<br>(K191222) | Comparison | | | | | |----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------|--------------------------------|-----------------------------|---------------------------------|--| | Device Name | Inclusive® Titanium Abutments compatible with:<br>Neoss® ProActive® Narrow, Neoss® ProActive® Standard, MIS® SEVEN®, Zimmer® Eztetic®<br>Implant Systems | Inclusive® Titanium Abutments compatible with: Dentsply Implants Astra Tech Implant<br>System® EV | N/A | | | | | | Manufacturer | Prismatik Dentalcraft, Inc. | Prismatik Dentalcraft, Inc. | Same | | | | | | Product Code | NHA | NHA | Same | | | | | | Prescription Device | Yes | Yes | Same | | | | | | Intended Use | Inclusive® Abutments are intended for use as an aid in<br>prosthetic rehabilitation. | Inclusive® Abutments are intended for use as an<br>aid in prosthetic rehabilitation. | Same | | | | | | Indications for Use | Inclusive® Titanium Abutments are premanufactured<br>prosthetic components connected to endosseous dental<br>implants in edentulous or partially edentulous maxilla<br>or mandible to provide support for cement-retained or<br>screw-retained prosthetic restorations.<br>All digitally designed abutments for use with<br>Inclusive® Titanium Abutments for CAD/CAM are<br>intended to be sent to a Prismatik Dentalcraft validated<br>milling center for manufacture.<br>Compatible Implant Systems: Neoss® ProActive®<br>Narrow, Neoss® ProActive® Standard, MIS®<br>SEVEN®, Zimmer® Eztetic® | Inclusive® Titanium Abutments are<br>premanufactured prosthetic components<br>connected to endosseous dental implants in<br>edentulous or partially edentulous maxilla or<br>mandible to provide support for cement-retained<br>or screw-retained prosthetic restorations.<br>All digitally designed abutments for use with<br>Inclusive® Titanium Abutments for CAD/CAM<br>are intended to be sent to a Prismatik Dentalcraft<br>validated milling center for manufacture.<br>Compatible Implant System: Dentsply Implants<br>Astra Tech Implant System® EV | Same except<br>for compatible<br>platforms | | | | | | | Compatible Implant<br>Fixtures | Implant<br>Body<br>Diameter | Implant<br>Platform<br>Diameter | Compatible Implant<br>Fixtures | Implant<br>Body<br>Diameter | Implant<br>Platform<br>Diameter | | | | Neoss® ProActive®<br>Narrow | 3.25 mm | Narrow<br>Platform (NP) | OsseoSpeed® EV<br>3.0S | 3.0 mm | 3.0 mm | | | Technological<br>Characteristics | Subject Device<br>(K231097) | | Predicate Device<br>(K191222) | | Comparison | | | | Neoss® ProActive®<br>Standard | 3.5 mm | Standard Platform (SP) | 3.6 mm | OsseoSpeed® EV 3.6Ss | | | | | | 4.0 mm | Platform (SP) | | | | | | | | 4.5 mm | | 4.2 mm | OsseoSpeed® EV 4.2S | | | | | | 5.0 mm | | | | | | | | | 5.5 mm | | 3.6 mm | OsseoSpeed® EV 4.2C | | | | | MIS® SEVEN® | 3.3 mm | Narrow Platform (NP) | | | | | | | | 3.75 mm | Standard Platform (SP) | 4.8 mm | OsseoSpeed® EV 4.8S | | | | | | 4.2 mm | Platform (SP) | 4.2 mm | OsseoSpeed® EV 4.8C | | | | | | 5.0 mm | Wide Platform (WP) | | | | | | | | 6.0 mm | (WP) | 5.4 mm | OsseoSpeed® EV 5.4S | | | | | Zimmer® Eztetic® | 3.1 mm | 2.9 mm | | | | | | | Design Characteristics<br><br>Material | Abutment<br>&Screw | Ti-6Al-4V ELI | | | | Same | | | | Multi-Unit<br>Coping & Screw | Ti-6Al-4V ELI | | | | Same | | | | Coping/<br>Superstructure | Y-TZP (ISO 13356) | | | | Same | | | | Cement | Shofu MonoCem resin cement (K020481) | | | | Same | | | Connection | Implant | Connection Design | Taper followed with a six-position indexing connection feature | | | Different connection design | | | | Neoss® ProActive®<br>Narrow | NeoLoc® connection feature – Inner flat cut toward curvature of the abutment's connection | | | | | | | | Neoss® ProActive®<br>Standard | toward curvature of the<br>abutment's connection | | | | | | | | MIS® SEVEN® | Hexagonal connection feature | | | | | | | | Zimmer® Eztetic® | feature | | | | | | | Titanium Abutment<br>Blank | Provided in 9.4mm diameter; To machine a patient-specific, engaging, one-piece abutment | | Provided in 9.4mm diameter; To machine a patient-specific, engaging, one-piece abutment | | | Same | | {8}------------------------------------------------ Image /page/8/Picture/0 description: The image contains the logo for Prismatik Dentalcraft, Inc. On the left is a triangle with a rainbow gradient. To the right of the triangle is the text "PRISMATIK DENTALCRAFT, INC." The text is in a sans-serif font and is blue. {9}------------------------------------------------ Image /page/9/Picture/0 description: The image contains the logo for Prismatik Dentalcraft, Inc. On the left side of the logo is a triangle with a gradient of colors, including pink, blue, yellow, and green. To the right of the triangle is the text "PRISMATIK DENTALCRAFT, INC." The text is in a sans-serif font and is blue. | Technological<br>Characteristics | Subject Device<br>(K231097) | Predicate Device<br>(K191222) | Comparison | |----------------------------------|------------------------------------------|------------------------------------------|----------------------------------------------------------------------| | Prosthetic Post<br>Height | 4.0 mm minimum | 4.0 mm minimum | Same | | Margin Height | 0.5 mm minimum | 0.5 mm minimum | Same | | Gingival Height | 6.0 mm maximum | 6.0 mm maximum | Same | | Angulation | 0° - 30° | 0° - 20° | Increased<br>angulation<br>range,<br>supported by<br>fatigue testing | | Prosthetic<br>Attachment | Cement-retained, Screw-retained | Cement-retained, Screw-retained | Same | | Restoration Types | Single-unit, Multi-unit | Single-unit, Multi-unit | Same | | Titanium Abutment | Engaging/Non-Engaging two-piece abutment | Engaging/Non-Engaging two-piece abutment | Same | | Prosthetic Post<br>Height | 4.0 mm minimum | 4.0 mm minimum | Same | | Margin Height | 0.5 mm minimum | 0.5 mm minimum | Same | | Gingival Height | 6.0 mm maximum | 6.0 mm maximum | Same | | Angulation | 0° | 0° | Same | | Prosthesis<br>Attachment | Cement-retained, Screw-retained | Cement-retained, Screw-retained | Same | | Restoration type | Single-unit, Multi-unit | Single-unit, Multi-unit | Same | {10}------------------------------------------------ Image /page/10/Picture/0 description: The image shows the logo for Prismatik Dentalcraft, Inc. The logo consists of a triangle on the left side that is filled with a gradient of colors, including blue, green, yellow, pink, and white. To the right of the triangle is the text "PRISMATIK DENTALCRAFT, INC." in a blue sans-serif font. # DETERMINATION OF SUBSTANTIAL EQUIVALENCE The subject device is substantially equivalent to the primary predicate device (K191222) listed above in intended use, material, design principles and technological characteristics. The subject device and the primary predicate device (K191222) include prefabricated, precision interface (implant/abutment connection) abutments that are manufactured from titanium alloy conforming to ASTM F136. The subject device and the primary predicate device (K191222) include Inclusive® Titanium Abutment Blanks intended to be used to fabricate one-piece, all-titanium, patient-specific abutments using CAD/CAM technology and Inclusive® Titanium Abutments 4.5mmH and 6mmH intended to be used for support of fabricated crowns/bridges or zirconia copings. Inclusive® Titanium Abutments are a two-piece abutment with a titanium base and a ceramic top half. Each patient-specific abutment is individually prescribed by the clinician and manufactured by Prismatik Dentalcraft, Inc. or a qualified validated milling center. The Indications for Use Statement (IFUS) for the subject device is substantially equivalent to that of the primary predicate device (K191222) except the compatible implant system due to different implant connection. Both devices have the same intended use as endosseous dental implant abutments for the support of a prosthesis to restore chewing function. The subject device designs are substantially equivalent to the corresponding design of the primary predicate device (K191222), including titanium blank abutments and titanium base abutments (engaging and non-engaging). The subject device and the primary predicate device (K191222) are for single-unit or multiple-unit restorations and for cement-retained or screw-retained prostheses. Both devices have internal implant interface connections and are made of titanium alloy Ti-6Al-4V conforming to ASTM F136 (abutments and abutment screws), and the titanium base abutments are to be used with zirconia superstructures. The subject device includes designs for abutment angulation up to 30°; this angulation range is similar to the primary predicate device (K191222), but increased angulation range from 20° to 30°. The subject device is compatible with the following OEM implant systems, Neoss® ProActive® Narrow, Neoss® ProActive® Standard, MIS® SEVEN®, Zimmer® Eztetic®, and the compatibility of the subject device and the OEM implants was established by dimensional analysis and reverse engineering analysis regarding specific critical dimensions. When the subject device is used according to its difference does not impact safety or effectiveness. Furthermore, mechanical performance testing was performed according to ISO 14801:2016, "Dentistry - Implants - Dynamic loading test for endosseous dental implants" and demonstrated that the subject device has sufficient strength for its intended use. The subject device is provided non-sterile and to be steam sterilized by the end-user. The validated moist heat sterilization method according to ISO 17665-1 and ISO 17665-2 is the same as the primary predicate device (K191222), and the reference devices K083192 and K160979. Substantial equivalence of the subject device components in terms of biocompatibility is supported by the fact that materials are identical in formulation, {11}------------------------------------------------ Image /page/11/Picture/0 description: The image shows the logo for Prismatik Dentalcraft, Inc. The logo consists of a colorful triangle on the left and the company name on the right. The triangle is divided into sections of different colors, including pink, red, yellow, green, blue, and purple. The company name is written in blue, with "PRISMATIK" on the top line and "DENTALCRAFT, INC." on the bottom line. processing, component interactions, and storage conditions to the primary predicate device (K191222) and the reference device (K160979). The biological evaluation was also performed on the subject device and concluded that there is no biocompatibility concern. #### VII. PERFORMANCE DATA Non-clinical testing data are submitted to demonstrate substantial equivalence. No clinical data was included in this submission. # Biocompatibility Evaluation Biocompatibility evaluation was conducted by following the FDA Guidance Document, Use of International Standard ISO 10993-1, "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process" and concluded that there is no biocompatibility concern. The subject device has the same material and manufacturing process at the same manufacturing facility as the primary predicate device (K191222) and the reference device (K160979); therefore, additional biocompatibility testing was not conducted. Cytotoxicity testing according to ISO 10993-5 was referenced from K160979 to demonstrate the biocompatibility of the final finished device consisting of the titanium abutment, zirconia coping and cement. Biological evaluation was used to address questions related to substantial equivalence between the subject device and the primary predicate device (K191222) in terms of biocompatibility. # Mechanical Properties Static load and fatigue testing of the implant/abutment assembly was considered according to the FDA Guidance Document. Guidance for Industry and FDA Staff Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments and ISO 14801:2016 standard with the worst-case scenario. The fatigue limit data demonstrated that the subject device has sufficient strength for its intended use. Reverse engineering of OEM implant bodies, OEM abutments, and OEM abutment screws was conducted to confirm compatibility. The results of the mechanical testing were used to address questions related to substantial equivalence based on the differences in technical specifications between the subject device and the primary predicate device (K191222). # Sterilization Validation The subject device is provided non-sterile intended to be steam sterilized by the end user with the same parameters as the primary predicate device (K191222) as validated by ISO 17665-1 and ISO 17665-2. The subject device has the same material and manufacturing process at the same manufacturing facility as the primary predicate device (K191222) and the reference device (K160979); therefore, additional sterilization was not conducted. Sterilization validation according to ISO 17665-1 and ISO 17665-2 were referenced from K083192 and K160979. The results of the previous testing were used to address questions related to substantial equivalence based on the differences in technical specifications between the subject device and the primary predicate device (K191222). {12}------------------------------------------------ Image /page/12/Picture/0 description: The image contains the logo for Prismatik Dentalcraft, Inc. The logo consists of a colorful triangle on the left and the company name on the right. The triangle is divided into sections, each with a different color, creating a prism effect. The company name is written in blue, with "PRISMATIK" on the top line and "DENTALCRAFT, INC." on the bottom line. # Shelf Life and Packaging Validation The subject device performance is not adversely affected by aging because the subject device is made from titanium alloy conforming to ASTM F136; this material is known to be stable in air at room temperature for an indefinite period of time. Shelf-life is not applicable because of low likelihood of time-dependent product degradation. A packaging validation according to ASTM D4169-16 was conducted to ensure that the packaging configurations for the subject device are suitable to withstand the distribution environment. It was determined that the packaging for the subject device is suitable for use. The results of the testing were used to address questions related to substantial equivalence based on differences in product packaging between the subject device and the primary predicate device (K191222). # Use in MR Environment Non-clinical MR review was performed to evaluate the metallic devices in the MR environment using scientific rationale and published literature (e.g., Woods, Terry O., Jana G. Delfino, and Sunder Rajan. "Assessment of Magnetically Induced Displacement Force and Torque on Metal Alloys Used in Medical Devices." Journal of Testing and Evaluation 49.2 (2019): 783-795), based on the subject device components and material composition. Rationale addressed parameters per the FDA guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment". #### VIII. CONCLUSION Based on the technological characteristics and non-clinical test data included in this submission, the subject device has been shown to be substantially equivalent to the predicate device (K191222).