X-cera Zirconia Blanks

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or a stylized human profile, composed of three interconnected faces in profile. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 March 29, 2016 Shenzhen XiangTong Photoelectricity Technology Co., Ltd. c/o Mr. Mark Job Regulatory Technology Services, LLC 1394 25th Street, NW Buffalo, MN 55313 Re: K153767 Trade/Device Name: X-cera Zirconia Blanks Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain powder for clinical use Regulatory Class: II Product Code: EIH Dated: March 9, 2016 Received: March 15, 2016 Dear Mr. Job: 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}------------------------------------------------ Page 2 - Mr. Mark Job 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 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/Resourcesfor You/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 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 vours. 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) K153767 Device Name X-cera Zirconia Blanks #### Indications for Use (Describe) X-cera Zirconia Blanks are indicated for the production of artificial teeth in fixed or removable dentures, or for jacket crowns, facings, and veneers. Type of Use (Select one or both, as applicable) | <span style="font-size:100%;">☑</span> 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}------------------------------------------------ # 510(k) Summary for # X-cera Zirconia Blanks # 1. 510(k) Number K153767 #### 2. Submission Sponsor Shenzhen XiangTong Photoelectricity Technology Co., Ltd. 2~4th floor, 1st Building, South Industrial park of Honghualing, Nanshan District, Shenzhen, China Phone: 0086-755-86001804 Fax: 0086-755-86001486 Contact: Yongqing Chen, Vice-President #### 3. Submission Correspondent Emergo Group 816 Congress Avenue, Suite 1400 Austin, TX 78701 Cell Phone: +86-21-22815850 Office Phone: (512) 327.9997 Fax: (512) 327.9998 Contact: Lee Fu, RAC, Senior Consultant, Regulatory Email: project.management@emergogroup.com #### 4. Date Prepared 03/29/2016 ## 5. Device Identification | Trade/Proprietary Name: | X-cera Zirconia Blanks | |----------------------------|-----------------------------------| | Common/Usual Name: | Zirconia Blocks | | Classification Name: | Porcelain powder for clinical use | | Classification Regulation: | 872.6660 | | Product Code: | EIH | | Device Class: | Class II | | Classification Panel: | Dental Devices | #### 6. Legally Marketed Predicate Device(s) Aidite Zirconia Dental Ceramics (K111291) {4}------------------------------------------------ #### 7. Device Description X-cera Zirconia Blanks are provided in either block, disc, cylinder shape and are derived from zirconia powder that has been processed via uni-axial die pressing, followed by iso-static pressing, to achieve final net shapes of uniform density and distribution. These Zirconia Blanks can be fabricated into various prosthetic dental device. X-cera Zirconia Blanks are offered in ten(10) different product families of shapes and a multitude of different sizes as shown in Figure 1 and Table 1 and are capable of being machined into complex dental shapes using modern machining methods and are similar to the sizes and shapes of the predicate device. Any difference in the net shapes and dimensions between X-cera Zirconia Blanks and those offered by the manufacturer of the predicate devices are incidental to the performance of the final dental prosthetic devices that will be fabricated from them. Image /page/4/Figure/4 description: The image shows a variety of Zirconia Blanks. There are 10 different types of Zirconia Blanks, including XS series, XQ series, XW series, XZ series, XC series, XZZ series, XO series, XK series, XA series, and XM series. The Zirconia Blanks are all white, but they come in different shapes and sizes. Figure 1 X-cera Zirconia Blanks | Table 2<br>X-cera Zirconia Blanks Product Family(Model) | | |---------------------------------------------------------|------------------------------------------------------------------| | Family(Model) | Shapes & Sizes available | | XQ series | Cylinder: Φ22*25(mm)<br>Disc: Φ98×8(mm) | | XW series | Discs: Φ100×10 to Φ100×25(mm) (with 3mm protruding step) | | XO series | Discs: Φ98×10 to 98×25(mm) (with 2mm protruding step) | | XA series | Discs: Φ100×10 to Φ100×25(mm) (with Φ112×6mm Outer plastic ring) | | XA series | Discs: Φ98×10 to Φ98×25(mm) (with Ø 115×10mm Outer ring) | | XA series | Discs: Φ71×10 to Φ71×25(mm) | | XA series | Blocks: 40×20×16 to 65×30×20(mm) | | XA series | Blocks: 90×72×10 to 90×72×25(mm)(outer ring) | | XK series | Discs: Φ98×10 to Φ98×25(mm) | | XK series | Blocks: 42×16×16 to 60×25×20(mm) | | XK series | Cylinders: Φ16×16 to Φ20×20(mm) | | XZ series | Discs: Φ95×10 to Φ95×25(mm) | | XZ series | Blocks: 43×25×16 to 93×75×25(mm) | {5}------------------------------------------------ | | Cylinders: $Φ$ 23×16 to $Φ$ 23×22(mm) | |------------|----------------------------------------------------------------| | XM series | Blocks: 43×25×16 to 75×42×22(mm) | | XC series | Cylinders $Φ$ 25×26 to $Φ$ 25×60(mm) (with Outer plastic ring) | | | Blocks: 26×25×20 to 72×40×25(mm) (with Outer plastic ring) | | XS series | Blocks: 20×14×15 to 85×40×22(mm) | | XZZ series | Discs: $Φ$ 95×10 to $Φ$ 95×25(mm) | Note: The form of size above has two forms, one is shown in D×H and the other is L×W× H, of which, "D"means Diameter, "H"means height, "L" means length, "W" means width. #### 8. Indication for Use Statement X-cera Zirconia Blanks are indicated for the production of artificial teeth in fixed or removable dentures, or for jacket crowns, facings, and veneers. #### 9. Substantial Equivalence Discussion The following table compares the X-cera Zirconia Blanks 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 | Shenzhen XiangTong<br>Photoelectricity<br>Technology Co., ltd. | Qinhuangdao Aidite<br>High-Technical Ceramics<br>Co. | SIGNIFICANT<br>DIFFERENCES | |---------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------| | Trade Name | X-cera Zirconia Blanks | Aidite Zirconia Dental<br>Ceramics | / | | 510(k) Number | / | K111291 | / | | Product Code | EIH | EIH | Same | | Regulation<br>Number | 21 CFR 872.6660 | 21 CFR 872.6660 | Same | | Regulation Name | Powder, Porcelain | Powder, Porcelain | Same | | Indications for Use | are indicated for the<br>production of artificial<br>teeth in fixed or<br>removable dentures, or<br>for jacket crowns,<br>facings, and veneers | are indicated for the<br>production of artificial<br>teeth in fixed or<br>removable dentures, or<br>for jacket crowns,<br>facings, and veneers | Same | | Directions for Use | Prescription Use | Prescription Use | Same | | Fundamental<br>Scientific<br>Technology | Iso static pressing | Iso static pressing | Same | | Main working<br>principle | Be capable of being<br>machined into complex<br>dental shapes using<br>modern machining | Be capable of being<br>machined into complex<br>dental shapes using<br>modern machining | Same | | Manufacturer | Shenzhen XiangTong<br>Photoelectricity<br>Technology Co., ltd. | Qinhuangdao Aidite<br>High-Technical Ceramics<br>Co. | SIGNIFICANT<br>DIFFERENCES | | Trade Name | X-cera Zirconia Blanks | Aidite Zirconia Dental<br>Ceramics | / | | | methods | methods | | | Applied Standards | ISO 6872<br>ISO 10993-1<br>ISO 7405 | ISO 6872<br>ISO 10993-1<br>ISO 7405 | Same | | Main Chemical<br>Composition (in<br>mass-%) | ZrO₂ 88% ~ 96%<br>Y₂O₃ 4% ~10%<br>Al₂O₃ <1%<br>HfO₂ <0.05%<br>SiO₂ <0.5% | ZrO₂ <96%<br>Y₂O₃>4%<br>Al₂O₃ <1%<br>HfO₂>1%<br>SiO₂ < 0.02% | Analysis 1 | | Crystal<br>Morphology | Tetragonal | Tetragonal | Same | | Color | white | white | Same | | Sintering<br>temperature | 1480°C | 1480°C | Same | | Sterile | Non-sterile | Non-sterile | Same | | Density (post<br>sintering) | 6.0~6.1 g/cm³ | 6.05g/cm³ | Analysis 2 | | Shrinkage (post<br>sintering) | 19%~22% | 22% | Analysis 3 | | Categorization<br>According to ISO<br>7405 and ISO<br>10993-1 | 1) Categorization by<br>nature of contact:<br>External communicating<br>devices<br>2) Categorization by<br>duration of contact<br>Permanent contact<br>devices | 1) Categorization by<br>nature of contact:<br>Surface-contacting<br>devices<br>2) Categorization by<br>duration of contact<br>Permanent contact<br>devices | Same | | Flexural Strength<br>(post sintering) | Comply with ISO 6872 | Comply with ISO 6872 | Same | | Elastic modulus<br>(post sintering) | 210±15 GPa | 210 GPa | Same | | Porosity | Less than 0.1% | 0% | Same | | Type and Class<br>according to ISO<br>6872 | Type II Class 6 | Type II Class 6 | Same | | Fracture Toughness<br>(after sintered) | Comply with ISO 6872 | Comply with ISO 6872 | Same | | Coefficient of linear<br>thermal expansion | $10.5±0.5×10^{-6} K^{-1} (25 °C~500°C)$ | $10.5±0.5×10^{-6} K^{-1} (25 °C~500°C)$ | Same | #### Table 3 – Comparison of Characteristics {6}------------------------------------------------ ## Analysis 1 They are both conformance with the requirement ISO 6872 Type II class 6. {7}------------------------------------------------ ## Analysis 2 The value of Density (post sintering) of Aidite Zirconia Dental Ceramics is a fixed value, and the range of the proposed cover the value of the predicate. Analysis 3 Proposed device and predicate device are both conformance to the same mechanical and chemical property and biocompatibility standard (ISO 6872, ISO 10993-1, ISO 7405). ## 10. Non-Clinical Performance Data The following testing has been performed to support substantial equivalence: - Flexural Strength Test - The test results of mean flexural strength (post sintering) comply with the ISO 6872: 2008 (≥800MPa) and product design requirement (≥900MPa). - . Density and Apparent Porosity Test - The test results of density and apparent porosity comply with the values specified by manufacturer in the Instruction for Use. - Shrinkage rate and Expand Rate Test - The test results of shrinkage rate and expand rate comply with the acceptance criteria. - . Physical and chemical test - The test results comply with the ISO 6872: 2008. - . Zirconia powder Composition Test - The test results comply with the design specifications and the values specified by manufacturer in the Instruction for Use. - . Biocompatibility Test – Results comply with ISO 7405 and ISO 10993 including In Vitro Cytotoxicity Test, Sensitization Test, Intracutaneous Reactivity Test, Acute Systemic Test, and Genotoxicity. The X-cera Zirconia Blanks passed all testing stated above as shown by the acceptable results obtained. The device passed all the testing in accordance with national and international standards. ## 11. 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. {8}------------------------------------------------ #### 12. 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. Or the device has the same intended use and different technological characteristics that can be demonstrated that the device is substantially equivalent to the predicate device, and that the new device does not raise different questions regarding its safety and effectiveness as compared to the predicate device. The X-cera Zirconia Blanks, as designed and manufactured, is determined to be substantially equivalent to the referenced predicate devices.