PRETTAU ANTERIOR T0

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, composed of three intertwined human profiles facing right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 October 8, 2015 Zirkonzahn Gmbh c/o Mr. Enrico Bisson Regulatory Senior Consultant TUV Rheinland Italia S.r.l. Via della Salute 18/3 Bologna, 40132 ITALY Re: K151490 Trade/Device Name: Prettau Anterior T0 Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain powder for clinical use Regulatory Class: II Product Code: EIH Dated: August 28, 2015 Received: September 3, 2015 Dear Mr. Bisson: 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 devicerelated 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 Industry and Consumer Education 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. 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 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 Industry and Consumer Education 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, Tina Kiang -S for 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}------------------------------------------------ # Indications for Use 510(k) Number (if known) K151490 Device Name PRETTAU® ANTERIOR T0 Indications for Use (Describe) PRETTAU® ANTERIOR TO is intended to be used for the manufacturing of metal free single-unit anterior and posterior prostheses, inlays, onlays, veneers bonded dental restorations. | Type of Use (Select one or both, as applicable) | |-------------------------------------------------| |-------------------------------------------------| > Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) ## 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}------------------------------------------------ # Section 05 510(k) Summary # 510 (k) Summary | APPLICANT | | |------------------|--------------------------------------------------------------------| | Company Name: | Zirkonzahn S.r.l. | | Company Address: | Gewerbegebiet - Zona Industriale an der Ahr 7<br>Gais, ITALY 39030 | | Company Phone: | +39 0474066660 | | Company Fax: | +39 0474066661 | | Company e-mail | info@zirkonzahn.com | | | | | CONTACT PERSON: | | | | Enrico Bisson | | | TÜV Rheinland Italia S.r.l. | | | Via della Salute 18/3 | | | 40132 Bologna (BO) - ITALY | | | Phone: +39 051404781 | | | Fax: +39 0516417389 | | | E-mail: enrico.bisson@gmail.com | Date Summary Prepared: October 5, 2015 # DEVICE IDENTIFICATION Trade/Proprietary Name: Generic/ Common Name: Classification name: Product Code: Panel: PRETTAU® ANTERIOR T0 Porcelain dental restorative system 21 CFR 872.6660, Porcelain powder for clinical use, Class II ElH Dental # LEGALLY MARKETED DEVICE (PREDICATE DEVICE) ICE Zirkon Transluzen Plus (K132230) by Zirkonzahn Srl # INTENDED USE: PRETTAU® ANTERIOR T0 is intended to be used for the manufacturing of metal free single-unit anterior and posterior prostheses, inlays, onlays, veneers bonded dental restorations. {4}------------------------------------------------ #### DEVICE DESCRIPTION PRETTAU® ANTERIOR T0 is a millable dental ceramic material made of zirconia. PRETTAU® ANTERIOR TO is destined for manufacture with CAD/CAM technology of metal free single-unit anterior and posterior prostheses, implant superstructures, inlays, onlays and veneers as fully anatomical restoration as well as for reduced structures for veneering with ceramics. The device is compatible with commercially available dental CAD/CAM systems must be validated by the user. The blocks are suitable for all milling units which are able to process presintered zirconia and which have the proper clamping device for the corresponding blank. PRETTAU® ANTERIOR TO is marketed in 25 different outer shapes, i.e. barrel, discs, rectangular, and special shapes; the blocks are produced in various heights from 10mm to 50 mm for each shape. ## DISCUSSION OF NON CLINICAL TESTS In consideration of the International Standard ISO 10993-1, Biological Evaluation of Medical Devices, Part 1: Evaluation and Testing, the same tests performed on the predicate device were performed on the final finished subject device to evaluate: In-vitro cytotoxicity, Skin sensitization, Mutagenicity, Irritation. Biocompatibility testing demonstrated that no issue of biocompatibility arises. Preattau Anterior was tested according to ISO 6872:2008 and is classified as Type II Class a&b and 2a esthetic dental ceramic. The device has been tested for flexural strength, chemical solubility, fracture toughness and CTE. The results of nonclinical tests demonstrate that the device is equivalent to the predicate device. ## SUBSTANTIAL EQUIVALENCE PRETTAU® ANTERIOR TO equals the predicate device with respect to the indications for use and the fundamental technology, relating to the use of zirconia blocks, the application process (CAD/CAM technology), the biocompatibility and other technical aspects. The differences in the composition between the new device and the predicate relate to the percentages of yttrium oxide and they have effect on the crystal structure and consequently on the translucency of the device; they have no material effects on the biocompatibility of the device. The composition has not been changed in way that may adversely impact the equivalence with the predicate device. The PRETTAU® ANTERIOR T0 has a lower mechanical strength than the predicate device (ICE Zirkon Transluzent Plus, 1200 Mpa), due to the fact that the material is completely stabilized with yttrium oxide in order to achieve higher translucency. The resistance to bending is however 600 Mpa, still well above the limits set by ISO 6872:2008. The section below provides a comparison chart of the submitted device and the predicate devices. Main comparison elements are as follows: {5}------------------------------------------------ | | PRETTAU® ANTERIOR T0 | K132230 - ICE Zirkon Transluzen Plus | | |------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|--| | | (Submitted Product) | (Legally Marketed Predicate Device) | | | Intended/<br>Indications For Use | For the manufacturing of single-unit<br>anterior and posterior prostheses,<br>inlays, onlays, veeners bonded dental<br>restorations. | For the fabrication of metal free single<br>and multiple unit crowns/bridges, inlays,<br>onlays bonded dental restorations. | | | Technology | CAD/CAM fabrication | CAD/CAM and layering ceramic System | | | Crystal form | cubic | tetragonal | | | Composition | ZrO2 residue<br>Y2 O3 9.35±0.02<br>Al2O3 0.05 ±0.01<br>SiO2 <=0.002<br>Fe2O3 <0.001<br>Na2O - | ZrO2 residue<br>Y2 O3 5.15±0.20<br>Al2O3 <= 0.1<br>SiO2 <= 0.02<br>Fe2O3 <0.01<br>Na2O <0.04 | | | Performance Specifications: | | | | | Flexural Strength (3-<br>pt bend), Mpa | 600 Mpa | 1200-1400 MPa | | | Chemical Solubility,<br>microgram/cm² | <10 µg/cm2 | <10 µg/cm2 | | | CTE at 500°C, 106/°C | 10.1 ± 0.5 x 10-6 K-1 m/m | 9.7 ± 0.5 x 10-6 K-1 m/m | | | Fracture toughness | 1,76 | 5,9 | | | Glass Transition<br>Temperature (Tg), °C | n.a. | n.a. | | Based on the available information, we conclude that the PRETTAU® ANTERIOR T0 is substantially equivalent to the existing legally marketed device under Federal Food, Drug and Cosmetic Act. Therefore, the subject device is determined a to be equivalent to the predicate device.