BruxZir NOW

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there 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. August 2, 2022 Prismatik Dentalcraft, Inc. So Hyun Park Regulatory Affairs Manager 2144 Michelson Drive Irvine, California 96212 Re: K220816 Trade/Device Name: BruxZir NOW Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder For Clinical Use Regulatory Class: Class II Product Code: EIH Dated: June 2, 2022 Received: June 3, 2022 Dear So Hyun 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 (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. 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 {1}------------------------------------------------ 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 mediation-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, For Michael E. Adjodha, M.ChE. 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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K220816 Device Name BruxZir® NOW Indications for Use (Describe) BruxZir® NOW is used for dental restorations using different CAD/CAM or manual milling machines. All blocks are processed through dental laboratories or by dental professionals. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------|--| |-------------------------------------------------|--| X 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." {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for Prismatik Dentalcraft, Inc. On the left is a triangle with a gradient of colors, ranging from pink to blue to yellow. To the right of the triangle is the company name, "PRISMATIK DENTALCRAFT, INC." in blue text. ### 510(k) Summary #### I. SUMBITTER 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: July 19, 2022 #### II. DEVICE Name of Device: BruxZir® NOW Common Name or Usual Name: Zirconia Milling Block or Dental CAD/CAM Block Classification Name: Porcelain powder for clinical use (21 CFR 872.6660) Regulatory Class: Class II Product Code: EIH #### III. PREDICATE DEVICE Primary Predicate Device: Perfit FS Dental Zirconia Fully Sintered Block (K203590) Reference Device: BruxZir® Shaded (K130924) #### IV. DEVICE DESCRIPTION BruxZir® NOW is a pre-shaded, fully sintered zirconia CAD/CAM block used for fabricating single-unit or multiple-unit dental restorations. BruxZir® NOW is used for fabricating single-unit dental restorations, while BruxZir® NOW Bridge Block is used for fabricating multiple-unit dental restorations. BruxZir® NOW is available in the following shades: Bleach White, Bleach 1, Bleach 3, and 16 VITA Classical shades (A1, A2, A3, A3.5, A4, B1, B2, B3, B4, C1, C2, C3, C4, D2, D3, D4). BruxZir® NOW Bridge Block is available in the following 6 VITA Classical shades: A1, A2, A3, B1, C2, D2. The method of fabricating the restoration is with CAD/CAM milling systems. {4}------------------------------------------------ Image /page/4/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, blue, and yellow. The company name is written in blue, with "PRISMATIK" on the top line and "DENTALCRAFT, INC." on the bottom line. #### INDICATIONS FOR USE V. BruxZir® NOW is used for dental restorations using different CAD/CAM or manual milling machines. All blocks are processed through dental laboratories or by dental professionals. #### VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS | | Technological<br>Characteristics | Subject Device<br>(K220816) | Predicate Device<br>(K203590) | Comparison | |----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------| | Technological<br>Characteristics | Device Name | BruxZir® NOW | Perfit FS Dental<br>Zirconia Fully<br>Sintered Block | N/A | | | Manufacturer | Prismatik Dentalcraft,<br>Inc. | Vatech Acucera, Inc. | N/A | | | Product Code | EIH | EIH | Same | | | Prescription Device | Yes | Yes | Same | | | Intended Use | BruxZir® NOW is<br>intended to be used in<br>fabrication of dental<br>restorations such as<br>crowns and bridges for<br>the purpose of<br>restoring chewing<br>function. | Perfit FS Dental<br>Zirconia Fully Sintered<br>Block is intended to be<br>used in fabrication of<br>dental restorations such<br>as crowns and bridges<br>for the purpose of<br>restoring chewing<br>function. | Same | | Design<br>Characteristics | Indications for Use | BruxZir® NOW is<br>used for dental<br>restorations using<br>different CAD/CAM or<br>manual milling<br>machines. All blocks<br>are processed through<br>dental laboratories or<br>by dental professionals. | Perfit FS Dental<br>Zirconia Fully Sintered<br>Block is used for dental<br>restorations using<br>different CAD/CAM or<br>manual milling<br>machines. All blocks<br>are processed through<br>dental laboratories or<br>by dental professionals. | Same except for the<br>device trade name | | | Material<br>Composition | The device is<br>composed of Yttria-<br>stabilized zirconia<br>(YSZ) and pigments to<br>achieve the desired<br>shades. | The device is<br>composed of Yttria-<br>stabilized zirconia<br>(YSZ) and pigments to<br>achieve the desired<br>shades. | Similar, both the subject<br>device and the predicate<br>device are composed of<br>Yttria- stabilized zirconia<br>as the primary<br>component and the | | Technological<br>Characteristics | Subject Device<br>(K220816) | Predicate Device<br>(K203590) | Comparison | | | Design | Fully sintered zirconia<br>block available in<br>block form in 2 sizes<br>for single and multiple-<br>unit restorations | Fully sintered zirconia<br>block available in block<br>form in various sizes | desired shades are<br>achieved by using<br>different pigments.<br>Different; The subject<br>device and the predicate<br>device are offered in<br>different shapes and<br>sizes. | | | Shades | BruxZir® NOW is<br>available in the<br>following shades:<br>Bleach White, Bleach<br>1, Bleach 3, and 16<br>VITA Classical shades<br>(A1, A2, A3, A3.5, A4,<br>B1, B2, B3, B4, C1,<br>C2, C3, C4, D2, D3,<br>D4). BruxZir® NOW<br>Bridge Block is<br>available in the<br>following 6 VITA<br>Classical shades: A1,<br>A2, A3, B1, C2, D2. | There are white<br>zirconia products<br>(White) and colored<br>zirconia products, and<br>colored zirconia is also<br>divided into Monolayer<br>(A1, A2, A3.5, A4, B1,<br>B2, B3, B4, C1, C2,<br>C3, C4, D2, D3, D4)<br>color products, Shade<br>multi-layer (ML<br>A1/A2/A3, A1M,<br>A2M, A3M, A3.5M,<br>A4M) color<br>products. | Different; The subject<br>device and the predicate<br>device are provided in<br>different shades. | | | Flexural<br>Strength | >800 MPa<br>Type II Class 5 per<br>ISO 6872:2015/Amd<br>1:2018 | ≥ 500 MPa<br>Type II Class 4 per ISO<br>6872:2015/Amd 1:2018 | Different; The flexural<br>strength of the subject<br>device is >800 MPa,<br>which is higher than the<br>flexural strength of the<br>predicate device. ISO<br>classification is also<br>different due to the<br>difference in flexural<br>strength. | | | Biocompatibility | Biocompatible per ISO<br>10993-1 | Biocompatible per ISO<br>10993-1 | Same | | | Solubility | <100 µg/cm² | <2000 µg/cm² | Different; The subject<br>device meets the ISO<br>solubility requirement for<br>Class 5. | | | Radioactivity | The activity | The activity | Same | | | Technological | Subject Device | Predicate Device | Comparison | | | Characteristics | (K220816) | (K203590) | | | | | Uranium-238 is no<br>more than 1.0 Bq/g. | Uranium-238 is no<br>more than 1.0 Bq/g. | | | Prismatik Dentalcraft, Inc. 510(k) Notification BruxZir® NOW March 2022 {5}------------------------------------------------ Image /page/5/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, blue, and yellow. The company name is written in blue, with "PRISMATIK" on the top line and "DENTALCRAFT, INC." on the bottom line. Prismatik Dentalcraft, Inc. 510(k) Notification BruxZir® NOW March 2022 {6}------------------------------------------------ Image /page/6/Picture/0 description: The image contains the logo for Prismatik Dentalcraft, Inc. The logo features a colorful triangle on the left side, with the company name written in blue text on the right side. The triangle is divided into several sections, each with a different color, creating a prism-like effect. The text is simple and easy to read. K220816 ## DETERMINATION OF SUBSTANTIAL EQUIVALENCE The subject device, BruxZir® NOW, is substantially equivalent to the predicate device, Perfit FS Dental Zirconia Fully Sintered Block (K203590) in intended use, indications for use, material, design principles and technological characteristics. The subject device, BruxZir® NOW, has the same intended use as the predicate device, Perfit FS Dental Zirconia Fully Sintered Block (K203590), as the material used in fabrication of dental restorations such as crowns and bridges for the purpose of restoring chewing function. The subject device, BruxZir® NOW, has the same indications for use statement (IFUS) as the predicate device, Perfit FS Dental Zirconia Fully Sintered Block (K203590), except for the device trade name. Both the subject device and the predicate device are dental restorative materials indicated for fabrication of dental restorations using CAD/CAM or manual milling machines. All blocks are processed through dental laboratories or by dental professionals. The subject device, BruxZir® NOW, is substantially equivalent to the predicate device, Perfit FS Dental Zirconia Fully Sintered Block (K203590), in technological characteristics. The same mechanical property testing in terms of flexural strength that was conducted on the predicate device, Perfit FS Dental Zirconia Fully Sintered Block (K203590), was also conducted on the subject device, BruxZir® NOW, according to ISO 6872:2015/Amd 1:2018. The flexural strength of the subject device, BruxZir® NOW, passed the threshold of performance criteria in ISO 6872 for Type II Class 5. The flexural strength of the subject device, BruxZir® NOW, is higher than that of the predicate device, Perfit FS Dental Zirconia Fully Sintered Block (K203590), which passed the threshold of performance criteria in ISO 6872 for Type II, Class 4. The subject device, BruxZir® NOW, and the predicate device, Perfit FS Dental Zirconia Fully Sintered Block (K203590), are similar in material composition. Both devices utilize Yttria-stabilized zirconia as the base material and pigments. Despite the differences in the pigments used to achieve the desired shades, the slight differences in chemical formulation do not affect the safety and effectiveness of the device as verified by the biocompatibility and performance testing. The subject device, BruxZir® NOW, and the predicate device, Perfit FS Dental Zirconia Fully Sintered Block (K203590), are substantially equivalent in terms of design. Both are offered in a fully sintered block form in different shapes and shades and are used to make {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the logo for Prismatik Dentalcraft, Inc. On the left is a triangle with a gradient of colors, including pink, red, yellow, green, blue, and purple. To the right of the triangle is the text "PRISMATIK DENTALCRAFT, INC." in a sans-serif font. final dental restorations based on the anatomical rendering of the patient's teeth using CAD/CAM equipment. #### VII. PERFORMANCE DATA Non-clinical data submitted to demonstrate substantial equivalence include: - Flexural Strength according to ISO 6872:2015/Amd 1:2018 ● - Solubility according to ISO 6872:2015/Amd 1:2018 ● - Shade evaluation - Biocompatibility according to ISO 10993-1:2018 ● - Radioactivity according to ISO 6872:2015/Amd 1:2018 - Packaging Validation according to ASTM D4169-16 ● No clinical data is included in this submission. ### Flexural Strength Flexural strength was tested on the worst-case groups for two types of BruxZir® NOW and BruxZir® NOW Bridge Block. The average flexural strength of each worst-case yielded the results above the minimum threshold of 800 MPa, which is the value to be achieved for Type II Class 5 ceramic product according to ISO 6872:2015/Amd 1:2018. The results of the testing were used to address questions related to substantial equivalence based on differences in technical specifications between the subject device, BruxZir® NOW, and predicate device. Perfit FS Dental Zirconia Fully Sintered Block (K203590). ## Solubilitv The worst case was tested for solubility and the measured value was <100 ug/cm² meeting the ISO 6872:2015/Amd 1:2018 requirement. The result of the testing was used to address questions related to substantial equivalence based on differences in technical specifications between the subject device, BruxZir® NOW, and predicate device, Perfit FS Dental Zirconia Fully Sintered Block (K203590). ### Shade Evaluation All shades offered for BruxZir® NOW were evaluated by the qualified evaluators using the sample dental restorations milled from the final sintered products against the corresponding VITA Classical shade guide and reference Bleach shade guide. Evaluations concluded that BruxZir® NOW meets shade match requirements and works as intended. The results of the testing were used to address questions related to substantial equivalence based on differences in technical specifications between the subject device, BruxZir® NOW, and predicate device. Perfit FS Dental Zirconia Fully Sintered Block (K203590). {8}------------------------------------------------ Image /page/8/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, red, yellow, green, and blue. To the right of the triangle is the text "PRISMATIK" in a larger, bold, blue font, with the text "DENTALCRAFT, INC." underneath it in a smaller, bold, blue font. ## Biocompatibility Biological evaluation within a risk management process was performed in accordance with ISO 10993-1:2018 and ISO 14971:2019. Based on the cytotoxicity testing results from the subject device, BruxZir® NOW, it was determined that there is no biocompatibility concern regarding yttria concentration, colorants, or other elements. The results of the testing were used to address questions related to substantial equivalence based on differences in chemical composition between the subject device, BruxZir® NOW, and the predicate device, Perfit FS Dental Zirconia Fully Sintered Block (K203590). ### Radioactivity BruxZir® NOW was tested to meet the radioactivity requirement of ISO 6872:2015/Amd 1:2018. BruxZir® NOW meets the radioactivity requirement since the sample measured below the Uranium-238 activity threshold of 1.0 Bq.g1 set by ISO 6872:2015/Amd 1:2018. The result of the testing was used to address questions related to substantial equivalence based on differences in technical specifications between the subject device, BruxZir® NOW, and predicate device, Perfit FS Dental Zirconia Fully Sintered Block (K203590). ### Packaging Validation The packaging validation was conducted to ensure that the packaging configurations for tBruxZir® NOW are suitable to withstand the distribution environment. Per ASTM D4169-16, BruxZir® NOW and BruxZir® NOW Bridge Block were tested to check resistance against manual handling, vehicle stacking, loose load vibration, vehicle vibration, and concentrated impact. After the test, the shipping containers were visually inspected for any damages. It was determined that the respective packaging for BruxZir® NOW blocks 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, BruxZir® NOW, and predicate device, Perfit FS Dental Zirconia Fully Sintered Block (K203590). #### VIII. CONCLUSION Based on the technological characteristics and non-clinical test data included in this submission, the subject device, BruxZir® NOW, has been shown to be substantially equivalent to the predicate device, Perfit FS Dental Zirconia Fully Sintered Block (K203590).