ADAMANT ZIRCONIA DISC

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is an abstract symbol that resembles a stylized caduceus, with three human profiles facing to the right. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 October 19, 2016 Adamant Co., Ltd. % Deborah Grayeski Sr. Project Manager M Squared Associates 575 Eighth Ave, Suite 1212 New York, New York 10018 Re: K160203 Trade/Device Name: ADAMANT ZIRCONIA DISC Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder For Clinical Use Regulatory Class: Class II Product Code: EIH Dated: September 14, 2016 Received: September 15, 2016 Dear Deborah Grayeski: 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. 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 {1}------------------------------------------------ with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801and Part 809); 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 and Part 809), 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, # Michael J. Ryan -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) K160203 Device Name ADAMANT ZIRCONIA DISC #### Indications for Use (Describe) Dental ceramic restorations made from ADAMANT ZIRCONIA DISC are indicated for crowns and multi-unit bridges (up to a maximum of three elements). Applications include both anterior and posterior regions. | Type of Use (Select one or both, as applicable) | | |-----------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------| | <span> <span style="font-size:16px">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> | <span> <span style="font-size:16px">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> | # 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) Number: K160203 # 510(k) Summary In accordance with 21 CFR 807.92, the following summary of information is provided: | Sponsor: | Adamant Co., Ltd.<br>1-16-7 Shinden, Adachi Ku<br>Tokyo, 123-8595, Japan<br>Tel: 81-3-3919-1171<br>Fax: 81-3-3913-3434 | |----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact: | Deborah Lavoie-Grayeski<br>M Squared Associates<br>575 Eighth Avenue, Suite 1212<br>New York, NY 10018<br>Ph: 703-562-9800 x250<br>Fax: 703-562-9797<br>Email: dgrayeski@msquaredassociates.com | | Date prepared: | October 18, 2016 | | Regulatory Class: | Class II | | Proprietary Name: | ADAMANT ZIRCONIA DISC | | Common Name: | Powder, Porcelain | | Classification Name: | Porcelain powder for clinical use | | Regulation Number: | 21 CFR 872.6660 | | Product Codes: | EIH | | Predicate Devices: | Cercon® Base, K051462<br>DD cubeX2, K150196 | # Indication for Use: Dental ceramic restorations made from ADAMANT ZIRCONIA DISC are indicated for crowns and multiunit bridges (up to a maximum of three elements). Applications include both anterior regions. # Device Description: The ADAMANT ZIRCONIA DISC is a ceramic block, composed of partially sintered yttria (yttrium oxide) stabilized zirconia (zirconium oxide) (Y-TZP) that can be cut/milled for forming dental restorations such as crowns and bridges (up to a maximum of three elements). Applications include both anterior and posterior regions. The ADAMANT ZIRCONIA DISC is designed for milled production on commercial CAD/CAM systems. After milling the disc, it is final sintered, so the Zirconia Disc is transformed into the {4}------------------------------------------------ object as dental restorations. ## Principle of Operation: ADAMANT ZIRCONIA DISC is derived from zirconia powder (zirconium oxide) that has been processed through molding and sintering into three different shapes. - a) Disc shape having groove around periphery. - b) Disc shape without groove - c) Rectangular solid Using commercially available CAD/CAM systems, these blanks are then further fabricated into various prosthetic dental devices, such as crowns and bridges. The dental restoration is then fired (i.e., sintered) in the oven to harden the ZrO2 so that its final properties can be achieved. All prosthetic dental devices are intended for single use applications. ADAMANT ZIRCONIA DISC is supplied in different colors originating from the different constituent of color additives; and different translucencies originate from small differences in the amount of Y2 O3. Finally, the restorations may be color shaded following the CAD/CAM process. The performance of formed zirconia dental blanks conforms to ISO 6872, Dentistry, Ceramic Materials. ## Technological Characteristics Summary: ADAMANT ZIRCONIA DISC is an oxide-based ceramic devices composed of partially sintered yttria stabilized zirconia powder indicated for dental restorations, such as crowns and bridges. The components of the ADAMANT ZIRCONIA DISC have been used in previously marketed devices and have been found safe for dental use. The data provided support the substantial equivalence of the subject device to the predicate devices for the indicated uses. # Technological Comparison with the Predicate Devices: The following table shows similarities and differences of use, design, and material between the subject device and the predicate devices. The predicates were chosen based upon their material composition, indications for use, and physical characteristics. {5}------------------------------------------------ 510(k) Premarket Notification ADAMANT ZIRCONIA DISC | Attribute | Subject Device | Predicate Devices | Predicate Devices | Comments | |-----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Trade Name | Adamant ZIRCONIA DISC | CERCON BASE | Dental Direkt cubeX2 | N/A | | 510(k) Number | K160203 | K051462 | K150196 | N/A | | Device<br>Description | The ADAMANT ZIRCONIA<br>DISC is a ceramic block,<br>composed of partially sintered<br>yttria (yttrium oxide) stabilized<br>zirconia (zirconium oxide) (Y-<br>TZP) that can be cut/milled for<br>forming dental restorations such<br>as crowns and bridges (up to a<br>maximum of three elements).<br>Applications include both anterior<br>and posterior regions. The<br>ADAMANT ZIRCONIA DISC is<br>designed for milled production on<br>commercial CAD/CAM systems.<br>After milling the disc, it is final<br>sintered, so the Zirconia Disc is | CERCON® BASE is a dense<br>ceramic composed of partially<br>sintered yttria (yttrium oxide)<br>stabilized zirconia (zirconium<br>oxide) powder (Y-TZP). It is<br>processed in the dental laboratory<br>by machining from a partially<br>sintered Y-TZP blank which is<br>then sintered to near full density<br>and then finally veneered with a<br>dental veneering ceramic. It is<br>designed for anterior and posterior<br>locations as a substructure<br>(framework) for single tooth or<br>bridge type restorations.<br>CERCON® BASE is essentially | DD cubeX2 is a semi-<br>finished dental blank made<br>of yttrium stabilized pre-<br>sintered zirconium dioxide,<br>which has a super high<br>translucency. The ceramics<br>is of type II (not powder),<br>Class 5 according to DIN<br>EN ISO 6872 (FDA<br>Recognition Number 4-<br>178). The DD cubeX2<br>dental blanks are designed<br>for milled production of<br>crowns and bridge<br>frameworks on commercial<br>CAD/CAM systems or | Same, with the exception that<br>the Adamant Zirconia Disc is<br>classified as Class 1, 2 and 3<br>(according to ISO 6872). | | | transformed into the object as<br>dental restorations. | equivalent to other Y-TZP<br>products currently in the market. | hand-operated copy milling<br>machines. | | | Regulatory Class | Class II | Class II | Class II | Same | | Intended Use | Dental ceramic restorations made<br>from ADAMANT ZIRCONIA<br>DISC are indicated for crowns and<br>multi-unit bridges (up to a<br>maximum of three elements).<br>Applications include both anterior<br>and posterior regions. | CERCON® BASE is indicated<br>for crowns, multi-unit bridges,<br>and inlay bridges. Applications<br>include both anterior and posterior<br>regions. | Dental blanks made from<br>DD cubeX2 are indicated<br>for crowns, multi-unit<br>bridges (up to a maximum<br>of three elements) and inlay<br>bridges. Applications<br>include both, anterior and<br>posterior bridges. | Same, with the exception that<br>the subject device is not<br>intended for inlay bridges. | | Multi-unit<br>bridges | Up to a maximum of three<br>elements. | Multi-unit bridges (with no more<br>than two pontics between<br>abutment crowns) | Up to a maximum of three<br>elements. | Same as K150196 | | Chemical Composition [Units] | | | | | | ZrO2 + HfO2 +<br>Y2O3 [wt%] | ≥ 99.0 | ≥ 99.0 | ≥ 99.0 | Same | | HfO2[wt%] | ≤ 5 | ≤ 2 | ca. 0.2 | Minor differences in | | Y2O3 [wt%] | ≤ 10 | ≤ 5 | < 10 | additives result in the | | Al2O3 [wt%] | ≤ 5 | ≤ 1 | < 0.1 | availability of different | | Other oxides | ≤ 5 | ≤ 1 | < 0.05 | colors and translucencies. | | Sterile | Non-sterile | Non-sterile | Non-sterile | Same | | ISO 6872<br>Categorization | Type II, Class 1, 2 and 3 (as the<br>product is not intended for<br>substructure) | Type II, Class 6 | Type II, Class 5 due to<br>restriction<br>to 3-element restorations | Same Type, but different<br>Class, as the Adamant<br>Zirconia Disc is not intended<br>for substructure, although its<br>technological characteristics<br>would support such use.<br>Therefore, substantial<br>equivalence is not affected.<br>Depending upon the color<br>variant of the Adamant<br>Zirconia Disc, the flexural<br>strength ranges from 515<br>MPa to 1349 MPa. The low-<br>end range of flexural strength<br>is mitigated by limitations set<br>forth in labeling as per ISO<br>6872. | | Bending/Flexural<br>Strength [MPa] | 515 MPa – 1349 MPa | 1200 MPa | >720 MPa | | | Density<br>(after sintering)<br>[g/cm3] | 6.04 ~ 6.33 g/cm³ | Unknown | > 6.0 | Same | | Biocompatibility | ISO 10993 | ISO 10993 | ISO 10993 | Same | | Physical Testing | ISO 6872 | ISO 6872 | ISO 6872 | Same | {6}------------------------------------------------ {7}------------------------------------------------ # Performance Data (Non-Clinical): Non-clinical testing was performed as follows. | Biocompatibility Test Performed | Result | |----------------------------------------------------------------------------|---------------------------------------------------| | Cytotoxicity test: Colony formation cytotoxicity test | Passed.<br>No cytotoxic effect. | | Intracutaneous reactivity in rabbits | Passed.<br>Met test requirements. | | Skin Sensitization Study in the Guinea Pig<br>(Maximization Method) | Passed.<br>No skin sensitization<br>produced. | | Genotoxicity: Bacterial Reverse Mutation Study | Passed.<br>Test article extracts<br>nonmutagenic. | | Test results according to Requirements of ISO 6872 | Result | | Uniformity of the material | Passed | | Freedom from extraneous materials | Passed | | Physical and chemical properties: Activity<br>concentration of uranium 238 | Passed | | Physical and chemical properties: Thermal expansion<br>coefficient | Passed | | Physical and chemical properties: Flexural Strength | Passed | | Physical and chemical properties: Chemical solubility | Passed | # Applicable Standards: - · ISO 10993-1, 10993-5, 10993-10, Biological evaluation of medical devices - · ISO 6872:2008, Dentistry Ceramic materials # Substantial Equivalence Conclusion: Both the subject and predicate devices are oxide-based ceramic devices composed of partially sintered yttria stabilized zirconia powder indicated for dental restorations, such as crowns and bridges. Both the subject and predicate devices have similar chemical compositions and physical characteristics. Data, including bench and biocompatibility test results, is provided to assess the effects of any technological differences between the subject device and the predicate. These data demonstrate that the device performs as intended and support a finding of substantial equivalence.