Z-CAD smile

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym followed by the full name of the agency, "U.S. Food & Drug Administration," on the right. The FDA part of the logo is in blue, with the acronym in a solid blue square and the agency's name in a lighter shade of blue. Metoxit AG Dr. Gian-Carlo Gullo CEO Emdwiesenstrasse 6 Thayngen, Switzerland CH-8240 August 23, 2018 Re: K170050 Trade/Device Name: Z-CAD Smile Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder For Clinical Use Regulatory Class: Class II Product Code: EIH Dated: May 28, 2018 Received: June 5, 2018 Dear Dr. Gian-Carlo Gullo: 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/cdrl/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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for {1}------------------------------------------------ devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 medical devices and radiation-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, # Mary S. Runner -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) K170050 Device Name Z-CAD Smile Indications for Use (Describe) METOXIT Z-CAD® smile blanks are indicated for the preparation of full ceramic crowns, inlays, veneers and 3 unit bridges in the anterior area. All white Z-CAD® smile blanks are indicated to be coloured with Z-CAD® Liquid smile-TC. The Z-CAD® Liquid smile-TC will be used to dye white pre-sintered zirconia restorations milled from Z-CAD® smile blanks in the dental field. | Type of Use (Select one or both, as applicable) | | |------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------| | <div> <span> <span style="font-size:16px">☒</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> <span style="font-size:16px">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> | #### 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 METOXIT, a high-tech ceramics company. The logo is in blue and features the company name in a bold, sans-serif font. Below the company name is the tagline "high tech ceramics" in a smaller, lighter font. The logo is simple and modern, and it conveys a sense of innovation and expertise. ### 510(k) Summary 510(k) Number: K170050 #### Submitter Contact Person Metoxit AG Emdwiesenstrasse 6 CH-8240 August 23rd 2018 Dr. Gian-Carlo Gullo (CEO) raqa@metoxit.com Phone: +41 52 6450101 / Fax: +41 52 6450100 Date Prepared #### Device | Name of Device | Z-CAD® smile | |---------------------|-----------------------------------| | Common Name | Powder, Porcelain | | Classification Name | Porcelain powder for clinical use | | Regulatory Class | II | | Product Code | EIH | 510(k) Number K170050 There were no prior submissions for the subject device. Primary Predicate Device Reference Devices Zolid FX, Amann Girrbach, K152383 DD cubeX2, Dental Direkt, K150196 Zenostar MT, Wieland, K152118 #### Device Description Z-CAD® smile ceramic blanks are indicated for the production of dental-prosthetic restorations. The blanks named above can be machined with CAM, CAD/CAM or copy milling systems commonly used in dental medical technology to produce dental-prosthetic restorations made from zirconium oxide. This material offers excellent properties with regards to bio-compatibility, stability and aesthetics, which make it the material of choice for the production of restorations for dental crowns, inlays, onlays, veneers, and up to three unit bridges, which in turn combine {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for METOXIT high tech ceramics. The word "METOXIT" is written in large, bold, blue letters. Below the word "METOXIT" is the phrase "high tech ceramics" written in a smaller font size. # 510(k) Summa the advantages of conventional casting technology and full ceramics. Dental technicians are therefore in a position to offer patients the extra added value when finishing the prosthesis. Metoxit Z-CAD® smile Blanks also includes Z-CAD® Liquids smile-TC. Z-CAD® Liquids smile-TC are ready for use water-based products, which are applied to the milled restauration prior to sintering to achieve individual shades. These liquids are specifically formulated for the dyeing of Z-CAD® smile blanks from Metoxit AG. #### Indications for Use METOXIT Z-CAD ® smile blanks are indicated for the preparation of full ceramic crowns, inlays, onlays, veneers and 3 unit bridges in the anterior area. All white Z-CAD® smile are indicated to be coloured with Z-CAD® liquid smile-TC. The Z-CAD® Liquid smile-TC will be used to dye white pre-sintered zirconia restorations milled from Z-CAD® smile blanks in the dental field. #### Comparison of Technological Characteristics with the primary predicate device Z-CAD® smile Blanks are for the preparation of full ceramic crowns, inlays, onlays, veneers and 3 unit bridges in the anterior area. This is similar to the indication for use stated for the primary predicate device, with the exception that the primary predicate device is also intended for use in the posterior range. All characteristics of the subject and the primary predicate device are compared in the table on page 02-4: Chemical Composition and specifications are similar for the subject and the primary predicate device. There are no significant deviations, and therefore no difference in safety and effectiveness. The material consists of ZrO2 + HfO2 + YzO3, YzO3, Al2O3 and other Oxides in the subject and the primary predicate device. The shapes and dimensions are also comparable for Metoxit Z-CAD smile and the primary predicate device. Additionally, the reference devices have been included in this submission to demonstrate equivalence in the range of dimensions. The shapes and dimensions do not influence the safety or the effectiveness. The defined specifications for Metoxit Z-CAD smile: Flexural Bending Strength, Coefficient of Thermal Expansion, Radioactivity (raw material) and Solubility (acetic acid) have no significant deviations to the primary predicate device. There is no difference in safety or effectiveness between the subject and the primary predicate device. {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for METOXIT high tech ceramics. The logo is in blue and features the company name in a bold, sans-serif font. Below the company name is the tagline "high tech ceramics" in a smaller font. The logo is simple and modern, and it conveys a sense of professionalism and expertise. ## 510(k) Summary #### Performance Data #### Shelf Life: Shelf-life for the Z-CAD® smile ceramic blanks was set at 10 years by Metoxit based on the risk assessment of the packaging material, as well as a confirmatory machining test performed on a product stored for more than 10 years. #### Biocompatibility testing: The biological risk assessment was performed based on the chemical composition of the subject device, which is similar to what is historically used for this device type. . The biological risk assessment was performed in accordance to ISO 10993-1. Additionally, a confirmatory cytotoxicity study was performed in accordance to ISO 10993-5. #### Bench test for each raw material or product batch: The proposed Z-CAD® smile was evaluated using the following performance bench testing to confirm the performance characteristics: | Physical properties | Units | Z-CAD®<br>smile<br>pass<br>criteria | Testing<br>method* | Primary<br>predicate<br>device | |-------------------------------|--------|-------------------------------------|--------------------|--------------------------------| | Bending strength<br>(biaxial) | MPa | $\ge$ 500 | ASTM C1161 | > 500 | | Solubility (acetic<br>acid) | µg/cm2 | $\le$ 100 | ISO 6872 | < 100 | | Radioactivity | Bq/kg | $\le$ 200 | GS | < 200 | {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for METOXIT high tech ceramics. The logo is in blue and consists of the word "METOXIT" in a stylized font. Below the word "METOXIT" is the phrase "high tech ceramics" in a smaller font. ### Table for comparison of technical characteristics between subject and primary predicate #### device | Trade Name | Z-CAD smile | Zolid FX | | |-------------------------------------|-------------------------------------------------------------------|--------------------------------------------------------------|--------------------------------------------------------| | | This submission | Primary predicate device | Evaluation of difference | | 510(k) number | K170050 | K152383 | | | 510(k) submitter/holder | METOXIT | Amann Girrbach | | | ZrO2 + HfO2 + Y2O3 | > 99.5 | $\ge 99.0$ | Equal or better | | Y2O3 | 9.3 | 9.15 – 9.55 | Equal or better | | Al2O3 | 0.05 | $\le 0.06$ | Equal or better | | Other Oxides | < 0.5 | -- | Equal or better | | Shape | Disks | Disks (U-shape) | Similar, does not influence<br>safety or effectiveness | | Dimensions | Various<br>(Diameter: 98.5<br>± 0.5 mm<br>Height: 10 to 25<br>mm) | Various<br>(Diameter: 90x70<br>mm<br>Height: 12 to 25<br>mm) | Similar, does not influence<br>safety or effectiveness | | Flexural Bending<br>Strength | 610 MPa | > 500 MPa | Equal or better | | Coefficient of Thermal<br>Expansion | $10*10^{-6}/K$ | $10.1 \pm 0.5*10^{-6}/K$ | Similar, does not influence<br>safety or effectiveness | | Radioactivity (raw<br>material) | < 45 Bq/kg | < 200 Bq/kg | Equal or better | | Solubility (acetic acid) | $\le 50 \mu g/cm2$ | $ < 100 \mu g/cm2$ | Equal or better | #### Conclusions All information provided in this premarket notification from Metoxit AG, supports the conclusion that Z-CAD® Smile is found substantially equivalent to the primary predicate device.