BruxZir Anterior

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a circular design with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract symbol consisting of three stylized human profiles facing to the right, stacked on top of each other. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 December 15,2014 Prismatik Dentalcraft, Inc. Mr. Armin Zehtabchi Senior RA Specialist 2212 Dupont Drive, Suite P Irvine, CA 92612 Re: K143330 Trade/Device Name: BruxZirTM Anterior Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: II Product Codes: EIH Dated: November 24, 2014 Received: November 26, 2014 Dear Mr. Zehtabchi: 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. 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours. Susan Runco DDS, MA Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ | Form Approved: OMB No. 0910-0120 | | |-----------------------------------|--| | Expiration Date: January 31, 2017 | | | See PRA Statement below. | | | DEPARTMENT OF HEALTH AND HUMAN SERVICES | | |-----------------------------------------|--| | Food and Drug Administration | | | <b>Indications for Use</b> | | | 510(k) Number ( <i>if known</i> ) | TBD | |-----------------------------------|-------------------| | Device Name | BruxZir™ Anterior | | K143330 | | | Indications for Use (Describe) | The device is indicated for use by dental technicians in the construction of custom made all ceramic restorations for anterior and posterior location. | |--------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------| |--------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------| | Type of Use ( <i>Select one or both, as applicable</i> ) | | |----------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | <div> <input checked="checked" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </div> <div> <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) </div> | PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED. FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (*Signature*) 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](mailto: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." | FORM FDA 3881 (1/14) | Page 1 of 1 | PSC Publishing Services (301) 443-6740 EF | |----------------------|-------------|-------------------------------------------| |----------------------|-------------|-------------------------------------------| {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 blue, with "PRISMATIK" on the top line and "DENTALCRAFT, INC." on the bottom line. B. ## 007_510 (K) Summary-807.92(c) This 510 (k) summary is being submitted in accordance with the requirements of SMDA of 1990 and 21 CFR 807.92. ### SUBMITTER INFORMATION A. | Company Name: | Prismatik Dentalcraft, Inc. | |-------------------------------|------------------------------------------------------------| | Company Address: | 2212 Dupont Dr., Suite P,<br>Irvine, CA 92612 | | Company Phone: | 949-225-1269 | | Company FAX: | 949-553-0924 | | Facility Registration Number: | 3005477956 | | Primary Contact Person: | Armin Zehtabchi, (949) 225-1234<br>Senior RA Specialist | | Secondary Contact Person | Marilyn Pourazar, (949) 225-1269<br>Senior Director, RA/QA | | Date Summary Prepared: | November 19, 2014 | | DEVICE IDENTIFICATION | | | Trade/Proprietary Name: | BruxZir™ Anterior | | 21 CFR Reference: | 21 CFR 872.6660 | | 21 CFR Common Name: | Porcelain powder for clinical use | | Classification: | Class II, EIH | | Panel: | Dental | ## C. IDENTIFICATION OF PREDICATE DEVICE BruxZir™ Shaded-K130924 Trade/Proprietary Name: {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for Prismatik Dentalcraft, Inc. On the left is a triangular prism with different colors. To the right of the prism is the company name, "PRISMATIK DENTALCRAFT, INC.", in a blue sans-serif font. The logo is clean and professional. #### PROPOSED DEVICE DESCRIPTION D. BruxZir" Anterior Blanks are zirconia milling blanks that are used for the production of highly esthetic full-contour zirconia dental restorations. The high esthetics of BruxZir" Anterior makes it ideal for use in the anterior region. The manufactured full contour dental restorations are made utilizing the CAD/CAM system for design and manufacture. The designed and manufactured full-contour dental restorations are then sintered at a high temperature. BruxZir" Anterior White will have to undergo color alteration prior to sintering (colorants not provided by Prismatik). No color needs to be added to preshaded BruxZirTM Anterior Blanks (150, 250, 350, 450, 550) before sintering. Basic staining and glazing techniques need to be used after sintering to achieve the desired shade. The sintered material exhibits maximum strength and translucent pearlescence. #### E. INDICATIONS FOR USE The device is indicated for use by dental technicians in the construction of custom made all ceramic restorations for anterior and posterior location. #### F. DETERMINATION OF SUBSTANTIAL EQUIVALENCE The comparison table below outlines and provides the similarities and the substantial equivalency of the predicate device, BruxZir" Shaded-K130924 (cleared by FDA on 05/16/2013) and the proposed BruxZir" Anterior. Prismatik believes that the comparative data presented in the preceding paragraphs demonstrate that proposed BruxZir" Anterior is essentially the same as currently marketed devices for the same indications for use, and supports our claim of substantial equivalence to predicate Class II devices under the classification of porcelain powder for clinical use (21 CFR 872.6660) that have previously been found to be substantially equivalent. Any differences between the proposed device, BruxZir" Anterior, and the predicate device do not introduce any new issues of safety or effectiveness. Both the proposed device and the predicate device consist of general porcelain powder material and have the same intended use. {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, green, yellow, orange, pink, and purple. 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. | | Predicate Devices | Proposed Device | |-----------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------| | | BruxZirTM Shaded (K130924) | BruxZirTM<br>Anterior | | Classification of Ceramic | Type II, Class 6 | Same | | Shapes / Sizes | Standard & "R", "Z" Type, "DD", "ZZ", "ZZ" Notch,<br>"N" Style Blocks, "L" Style | Standard & "R", "Z"<br>Type, "DD", "ZZ",<br>"ZZ" Notch, | | Shades | Base Shades (4) | Base Shades (5) | | Final Vita Shades | A1, B1, C1, A2, A3, B2, A3.5, B3, C2, D2, D3, D4,<br>A4, B4, C3, C4 | Same | | Material | Tosoh Powder | Same | | Additional Material | Coloring Liquids | Same | | Flexural Strength | Meets requirements, per ISO 6872 | Same | | Coefficient of Thermal<br>Expansion (CTE) /<br>(25-500°C) | 11 x 10-6/K | Same | | Density | 6.05 g/cm3 | Same | | Biocompatibility | Biocompatible & Non-toxic | Same | | Indications for Use | The device is indicated for use by dental technicians<br>in the construction of custom made all ceramic<br>restorations for anterior and posterior location. | Same | # Table 1 – Comparison between Predicate and Proposed Device {6}------------------------------------------------ Image /page/6/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 several sections, each with a different color, including pink, red, yellow, green, blue, and purple. The company name is written in a sans-serif font and is blue. #### G. SUMMARY OF NON-CLINICAL TESTING (PERFORMANCE DATA) Non-clinical test data was used to support the substantial equivalency. The functionality of the BruxZir™ Anterior Blocks as well as their conformance to design input was further determined by performance testing (flexural strength, translucency, shades/color consistency and the coefficient of thermal expansion (CTE)). In addition, the proposed device, BruxZir™ Anterior blocks, has been tested for biocompatibility. #### CONCLUSION FROM THE NON-CLINICAL TESTING (PERFORMANCE DATA) H. The proposed device, BruxZir™ Anterior Blocks, has the same performance specifications, fundamental scientific technology and intended use as that of the predicate device, BruxZir™ Shaded-K130924 (cleared by FDA on 05/16/2013). The changes to the device do not raise any new questions regarding safety or efficacy. The performance data and a declaration of conformity with design controls support a determination of continuing substantial equivalence of the proposed device to the predicate device.