Luxisse+

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are rendered in a dark color, creating a sense of depth. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the image. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 May 6, 2015 Heany Industries. Inc. c/o Carrie Hetrick, DDS Emergo Group 816 Congress Avenue, Suite 1400 Austin, TX 78701 Re: K150056 Trade/Device Name: Luxisse + Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: II Product Codes: EIH Dated: February 6, 2015 Received: February 9, 2015 Dear Dr. Hetrick: 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. Tina Kiana -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) Device Name "Luxisse +" Indications for Use (Describe) Heany Industries, Inc. "Luxisse +" is non-implantable Zirconia material intended for CAD/CAM fabrication of all ceramic dental restorations. The material is used for the manufacturing of inlays, veneers, single unit anterior and posterior crowns, and three unit anterior bridges. Type of Use (Select one or both, as applicable) 2 Prescription Use (Part 21 CFR 801 Subpart D) _ Over-The-Counter Use (21 CFR 801 Subpart C) #### 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 Druq 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}------------------------------------------------ # 510(k) Summary for # "Luxisse +" ### 1. Submission Sponsor Heany Industries, Inc. 249 Briarwood Lane Scottsville, NY 14546 United States of America Phone: (585) 889-2700 Fax: (585) 889-2708 Contact: Cliff Rabidoux, Senior VP # 2. Submission Correspondent Emergo Group 816 Congress Avenue, Suite 1400 Austin, TX 78701 Cell Phone: (720) 838.4113 Office Phone: (512) 327.9997 Fax: (512) 327.9998 Contact: Carrie Hetrick, Senior Consultant, RA Email: project.management@emergogroup.com ### 3. Date Prepared 5/4/2015 # 4. Device Identification | Trade/Proprietary Name: | "Luxisse +" | |----------------------------|-----------------------------------| | Common/Usual Name: | Porcelain powder for clinical use | | Classification Name: | Powder, Porcelain | | Classification Regulation: | 21 CFR § 872.6660 | | Product Code: | EIH | | Device Class: | Class II | | Classification Panel: | Dental | ### 5. Legally Marketed Predicate Device(s) Heany Industries, Inc. Dental Zirconia 510(k) Number K073314 (Predicate) VITA Zahnfabrik H. Rauter GmbH & Co. Vita Suprinity 510(k) Number K132070 (Reference) ### 6. Device Description Heany Industries Inc. "Luxisse +" is an all ceramic core dental material made of Yttria-Stabilized Zirconium Oxide (zirconia, YSZ). It is provided as a block or disk shape. CAD/CAM {4}------------------------------------------------ fabrication of core material can then be used to produce copings and substrates for fixed all ceramic dental restorations above the gum line. The material is used for the manufacturing of inlays, onlays, veneers, single unit posterior and anterior crowns, and three unit anterior bridges. The material is then fired in an oven to harden the ZrO2. The milling and final oven hardening is completed by the customer. ## 7. Indication for Use Statement Heany Industries, Inc. "Luxisse +" is non-implantable Zirconia material intended for CAD/CAM fabrication of all ceramic dental restorations. The material is used for the manufacturing of inlays, onlays, veneers, single unit anterior and posterior crowns, and three unit anterior bridges. # 8. Substantial Equivalence Discussion The following table compares the "Luxisse +" to the predicate device with respect to intended use, technological characteristics and principles of operation, providing more detailed information regarding the basis for the determination of substantial equivalence. | Manufacturer | Heany Industries, Inc. | Heany Industries, Inc<br>(Predicate) | |--------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Trade Name | "Luxisse +" | Dental Zirconia | | 510(k) Number | K150056 | K073314 | | Product Code | EIH | EIH | | Regulation Number | 21 CFR § 872.6660 | 21 CFR § 872.6660 | | Regulation Name | Porcelain Powder for Clinical Use | Porcelain Powder for Clinical Use | | Indications for Use | Heany Industries, Inc. "Luxisse +" is<br>non-implantable, machinable Zirconia<br>material intended for CAD/CAM<br>fabrication of all ceramic dental<br>restorations. The material is used for<br>the manufacturing of inlays, onlays,<br>veneers, single unit anterior and<br>posterior crowns, and 3 unit anterior<br>bridges. | Heany Industries Inc. Dental Zirconia is<br>non-implantable material intended for<br>CAD/CAM fabrication of core material<br>used in all-ceramic dental restorations.<br>The material is used for the<br>manufacturing of inlays, onlays,<br>veneers, crowns and bridges | | Material (wt%) | Zirconia<br>99.8 wt% [ZrO2 + Y2O3 + HfO2 + Al2O3] | Zirconia<br>99.55-99.7 wt% [ZrO2 + Y2O3 + HfO2 +<br>Al2O3] | | Shapes | Blocks, disks | Blocks, disks | | Dimensions | Various | Various | | Supplied Sterile | No | No | | Single Use | Yes | Yes | | Bulk density, g/cm³<br>(sintered) | 6.05 g/cm³ | 6.05 g/cm³ | | Porosity | < 0.5 % | < 0.5 % | | Flexural Strength,<br>MPa (sintered) | 546 MPa | 1200 MPa ± 150 MPa | | Fracture Toughness | 5.83 MPam0.5 | 8 MPam0.5 | #### Table 1: Device Comparison Chart {5}------------------------------------------------ | Manufacturer | Heany Industries, Inc. | Heany Industries, Inc<br>(Predicate) | |----------------------------------|------------------------|--------------------------------------| | Trade Name | "Luxisse +" | Dental Zirconia | | Thermal Expansion: | $10 x 10^{-6}/K$ | $10 x 10^{-6}/K$ | | Thermal<br>Conductivity: | 2.5 W/mK | 2.5 W/mK | | Chemical Solubility<br>in Water: | < 10 µg/cm2 | -14 µg/cm2 | | Sintering<br>Temperature (°C) | 1450 °C | 1450 °C | | Translucency | 41% Transmittance | 49% Transmittance | The "Luxisse +" device shares the same or similar indications for use, device operation, overall technical and functional capabilities, and therefore is substantially equivalent to the predicate device. All of the components have been used in legally marketed devices. The formulations have not been changed in ways that may adversely impact device performance. # 9. Non-Clinical Performance Data Non-clinical testing was performed in order to validate the design against the Company's specified design requirements for physical and chemical properties, as well as flexural strength, and to assure conformance with the consensus design standard ISO 6872:2008. "Luxisse +" is classified as Type II Class 1a and b, 2a, and 4b esthetic dental ceramic. The disks and blocks can be fabricated into various prosthetic dental devices and the zirconia powder conforms to ISO 6872:2008, Dentistry - Ceramic Materials and BS EN 1641:2004, Dentistry, Medical Devices for Dentistry, Materials. The table below summarizes the results. | Test | Conclusion | |-------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Radioactivity<br>Concentration | The results meeting the predefined criteria as specified in ISO 6872: 2008 (E) supports a finding of substantial equivalence | | Flexural Strength | The results met the requirements as specified in ISO 6872: 2008(E). Weibull statistics were used to better describe the distribution of strength. Ceramic materials exhibit unusually wide scatter in measured strength values due to a distribution of strength limiting defects. High variation in strengths cannot be accounted for solely by experimental error. | | Uniformity | The results meeting the predefined criteria as specified in ISO 6872: 2008 (E) supports a finding of substantial equivalence. | | Coefficient of thermal<br>expansion (CTE) | The CTE results meeting the predefined criteria as specified in ISO 6872: 2008 (E) supports a finding of substantial equivalence. | | Fracture Toughness<br>(KIC) | The results meeting the predefined criteria as specified in ISO 6872: 2008 (E) supports a finding of substantial equivalence. | | Chemical Solubility | The results meeting the predefined criteria as specified in ISO 6872: 2008 (E) supports a finding of substantial equivalence. | Table 2: Testing performed for the "Luxisse +" 510(k) Submission {6}------------------------------------------------ The "Luxisse +" meets all the requirements for overall design and biocompatibility, and performance testing confirms that the output meets the design inputs and specifications. The "Luxisse +" passed all testing stated above as shown by the acceptable results obtained. The "Luxisse +" complies with the applicable voluntary standards for performance. The device passed all the testing in accordance with national and international standards. # 10. Clinical Performance Data There was no clinical testing required to support the medical device as the indications for use is equivalent to the predicate device. These types of devices, including the predicate devices, have been on the market for many years and there are no adverse reactions. The non-clinical testing detailed in this submission supports the substantial equivalence of the device. # 11. Statement of Substantial Equivalence By definition, a device is substantially equivalent to a predicate device when the device has the same intended use and the same technological characteristics as the previously cleared predicate device. The "Luxisse +" has the same or similar intended use, indications, principles of operation, and technological characteristics as the predicate devices. "Luxisse +", as designed and manufactured, is determined to be substantially equivalent to the referenced predicate devices in terms of intended use, design, materials, and function.