BruxZir Steel

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The FDA logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym along with the full name of the agency on the right. The Department of Health & Human Services logo features a stylized human figure, while the FDA part includes the acronym "FDA" in a blue square, followed by "U.S. FOOD & DRUG" and "ADMINISTRATION" in blue text. June 10, 2020 Prismatik Dentalcraft, Inc. So Hyun Park Sr. Regulatory Affairs Specialist 2212 Dupont Drive. Suite P Irvine, California 92612 Re: K200131 Trade/Device Name: BruxZir Steel™ Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder For Clinical Use Regulatory Class: Class II Product Code: EIH Dated: May 15, 2020 Received: May 18, 2020 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part {1}------------------------------------------------ 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 (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 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, for Srinivas "Nandu" Nandkumar, Ph.D. Director DHT1B: Division of Dental 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) K200131 Device Name BruxZir Steel™ ### Indications for Use (Describe) BruxZir Steel™ can be used as an accessory to zirconium dioxide dental restorative material to provide individual tooth (or teeth) shading and to produce a strong prosthesis with a porcelain-like finish. It is intended to be used solely by certified dental technicians for fabrication of zirconium dioxide restorations for individual dental patients. Type of Use (Select one or both, as applicable) | <span> <span style="font-size: 20px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> | |-----------------------------------------------------------------------------------------------------------| | <span> <span style="font-size: 20px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> | ### 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 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. ## 510(k) Summary #### SUBMITTER INFORMATION A. B. | Company Name: | Prismatik Dentalcraft, Inc. | |---------------------------------------|-------------------------------------------------------------------------------------------------------| | Company Address: | 2212 Dupont Drive, Suite P<br>Irvine, CA 92612 | | Company Phone: | +1 949-863-5479 | | Company Fax: | +1 949-553-0924 | | Establishment<br>Registration Number: | 3011649314 | | Primary Contact Person: | So Hyun Park<br>Sr. Regulatory Affairs Specialist<br>So.park@glidewelldental.com | | Secondary Contact Person: | Herbert Schoenhoefer<br>RA/QA Director<br>Herbert.Schoenhoefer@glidewelldental.com<br>+1 949-440-2632 | | Date Summary Prepared: | June 9, 2020 | | DEVICE IDENTIFICATION | | | Trade/Proprietary Name: | BruxZir Steel™ | |-------------------------|-----------------------------------| | Common Name: | Dental restorative material | | Classification Name: | Porcelain powder for clinical use | | Regulation Number: | 21 CFR 872.6660 | | Product Code: | EIH | | Device Class: | Class II | | Classification Panel | Dental Products Panel | | Reviewing Branch: | Dental Devices Branch | {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 several sections, each with a different color. The company name is written in a sans-serif font. #### C. IDENTIFICATION OF PREDICATE DEVICE Primary Predicate: DMAX Coloring Liquid (K173769) Reference Device: ZirBlank®-FS (K070045) #### D. DEVICE DESCRIPTION BruxZir Steel™ is a Coloring Liquid used to produce a natural whitening effect while increasing the flexural strength and fracture toughness of 4.6 - 4.9 mol% yttriastabilized zirconia (YSZ). The product increases the shade esthetics of the restoration while maintaining the translucency. Application of the zirconia substrate prior to sintering provides enhanced shade characteristics and improved flexural strength and fracture toughness. #### E. INDICATIONS FOR USE BruxZir Steel™ can be used as an accessory to zirconium dioxide dental restorative material to provide individual tooth (or teeth) shading and to produce a strong prosthesis with a porcelain-like finish. It is intended to be used solely by certified dental technicians for fabrication of zirconium dioxide restorations for individual dental patients. #### F. DETERMINATION OF SUBSTANTIAL EQUIVALENCE The subject device, BruxZir Steel™, is substantially equivalent to the primary predicate device, DMAX Coloring Liquid, (K173769) in intended use, material, design and performance. The Indications for Use Statement (IFUS) for the subject device is substantially equivalent to that of the primary predicate. Both the subject device and the primary predicate device can be used as an accessory to zirconium dioxide dental restorative material to provide individual tooth (or teeth) shading and intended to be used solely by certified dental technicians for fabrication of zirconium dioxide restorations for individual dental patients. Slight difference in the subject device and primary predicate device Indications for Use does not affect the intended use and is supported by the reference device, ZirBlank®-FS (K070045). The subject device and the reference device include tantalum. The performance testing data also supports a new indication for use by showing that the subject device increases the flexural strength and fracture toughness of zirconia. Both IFUS express equivalent intended use to facilitate fabrication of zirconium dioxide restorations for individual dental patients, and indication for a strong prosthesis with a porcelain-like finish is expressed equivalently using different specific wording. {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 several sections, each with a different color. The company name is written in blue, with "PRISMATIK" on the top line and "DENTALCRAFT, INC." on the bottom line. 3 ### K200131 The differences between the predicate device and the subject device in terms of chemical composition are the presence of tantalum(V) oxide, less amount of silicon dioxide, and absence of sodium in the subject device. After sintering, the remaining tantalum pentoxide, which is incorporated into the zirconia substrate, is proven biocompatible. Silicon dioxide in the predicate device is a whitening agent, which makes the zirconia restoration whiter. The absence of sodium in the subject device does not affect the intended use. Although the base solutions for BruxZir Steel™ and DMAX Coloring Liquid are not identical (i.e. alcohol-based solution and water-based solution respectively), the difference does not affect the intended use, performance characteristics, or principle of operation. The subject device and the reference device employ tantalum prior to sintering the zirconia substrate. Substantial equivalence of the subject device components to the reference device in terms of biocompatibility is supported by the fact that tantalum has been acknowledged as being biocompatible for use in dental applications. Nonetheless, biocompatibility testing was performed on the subject device and the device was proven biocompatible. The comparison table below (Table 7-1) outlines and provides the similarities and differences among the subject device, primary predicate device and reference device. In summary, the subject device is substantially equivalent to the predicate device. #### PERFORMANCE DATA G. Non-clinical data submitted to demonstrate substantial equivalence included: - Biocompatibility according to ISO 10993-5:2009 and ISO 10993-10:2010 ● - The Cytotoxicity Report shows that there was no evidence of causing cell । lysis or toxicity. - The Sensitization Report shows that there was no reaction on the tested subject. - The Irritation Report shows that the test article was considered a nonirritant. - - Mechanical testing for flexural strength, fracture toughness, solubility . according to ISO 6872:2015 - . L* value obtained from L*a*b* color space testing after applying BruxZir Steel™ onto zirconia for dental restoration according to ISO 11664-4:2019. Biological evaluation within a risk management process was performed in accordance with ISO 10993-1:2018 and EN ISO 14971:2012. No clinical data were included in this submission. {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for Prismatik Dentalcraft, Inc. The logo includes a colorful triangle on the left side. The number 4 is located to the bottom left of the triangle. The text "PRISMATIK DENTALCRAFT, INC." is located to the right of the triangle. #### CONCLUSION H. The documentation submitted in this premarket notification demonstrates that the BruxZir Steel™ is substantially equivalent to the predicate device. {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the logo for PRISMATIK DENTALCRAFT, INC. To the left of the text is a triangular graphic with a color gradient. The number 5 is located to the left of the triangle. ## Table 7-1 – Comparison between predicate device and subject device | Feature | Subject Device | Primary Predicate | Reference Device | |----------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device Name | BruxZir Steel™ | DMAX Coloring Liquid | ZirBlank®-FS | | 510(k) | K200131 | K173769 | K070045 | | Regulation | 21 CFR 872.6660 | 21 CFR 872.6660 | 21 CFR 872.6660 | | Product Code | EIH | EIH | EIH | | Classification | II | II | II | | Indications for Use | BruxZir Steel™ can be used as<br>an accessory to zirconium<br>dioxide dental restorative<br>material to provide individual<br>tooth (or teeth) shading and to<br>produce a strong prosthesis with<br>a porcelain-like finish. It is<br>intended to be used solely by<br>certified dental technicians for<br>fabrication of zirconium dioxide<br>restorations for individual dental<br>patients. | DMAX coloring liquid can be<br>used as an accessory to zirconium<br>dioxide dental restorative material<br>to provide individual tooth (or<br>teeth) shading. It is intended to be<br>used solely by certified dental<br>technicians for fabrication of<br>zirconium dioxide restorations for<br>individual dental patients. | Intended for use in<br>preparation of crowns,<br>facings, inlays and onlays - to<br>produce a hard prosthesis<br>with a porcelain-like finish.<br>Frequently used with<br>porcelain overlay for<br>translucence and related effects.<br>For fabricating copings and<br>frameworks for inlays, onlays,<br>veneers, crowns, anterior and<br>posterior bridge restorations.<br>Intended to restore carious lesions<br>or structural defects in teeth. It is<br>intended for use in cavities Classes<br>I, II, and V (inlays and onlays) and<br>as a restorative material intended<br>for veneers, crowns and bridges. | | Feature | Subject Device | Primary Predicate | Reference Device | | Contraindication | Do not use on 3Y zirconia. | None | None | | Prescription<br>Device | Yes | Yes | Yes | | Environment of<br>Use | Dental laboratories | Dental laboratories | Dental laboratories | | Design | Alcohol-based Tantalum<br>Ethoxide solution with<br>burn-out at 100% during<br>sintering, which is<br>incorporated into a zirconia<br>substrate as sub-micron sized<br>Tantalum Pentoxide | Water-based with inorganic<br>pigments applied to zirconium<br>dioxide dental restorative material<br>before sintering | Tantalum Pentoxide added to a<br>yttrium oxide-stabilized zirconia<br>(Y-TZP) | | Principle of<br>Operation | Brush zirconia ceramic with<br>coloring liquid before sintering | Brush or immerse zirconia<br>ceramic with coloring liquid<br>before sintering | Not Applicable | | Shade | 1 color | 45 colors | Not Applicable | | Storage Conditions | Store at 22-25°C | Store at 2-28°C | Store at room temperature | | Flexural Strength<br>of Tantalum<br>Treated Zirconia | 1 GPa | Not Applicable | 600 MPa | | Fracture<br>Toughness of<br>Tantalum Treated<br>Zirconia | $≥5.0 MPa · m1/2$ | Not Applicable | $≥5.0 MPa · m1/2$ | | Feature | Subject Device | Primary Predicate | Reference Device | | Solubility of<br>Tantalum Treated<br>Zirconia | $ \leq $ 100 µg/cm² | $ \leq $ 100 µg/cm² | $ \leq $ 100 µg/cm² | | Biocompatibility | Biocompatible | Biocompatible | Biocompatible | | Sterility | Non-Sterile | Non-Sterile | Non-Sterile | {8}------------------------------------------------ Image /page/8/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 to the right. The number 6 is located on the bottom left corner of the image. {9}------------------------------------------------ Image /page/9/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 number 7 is located to the left of the triangle.