Luminesse Shaded Zirconia SZ

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. 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 September 15, 2016 Talladium, Inc. Mr. Edward Harms President/CEO 27360 West Muirfield Lane Valencia, California 91355 Re: K152023 Trade/Device Name: Luminesse Shaded Zirconia SZ Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: Class II Product Code: EIH Dated: June 7, 2016 Received: June 20, 2016 Dear Mr. Harms: 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 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. {1}------------------------------------------------ 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, Susan Runco, DDS, MA 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}------------------------------------------------ #### DEPARTMENT OF HEAL11 AND HUMAN SERVICES Food and Drug Administration #### Indications for Use Form Approved: OMB No.0910.0120 Expiration Date: January 31,2017 Se& PRA Statement below. 510(k) Number (if known) K152023 #### Device Name Luminesse Shaded Zirconia SZ Indications for Use (Describe) Luminesse Shaded Zirconia SZ blanks/discs are indicated for use with CAD/CAM technology or manual milling machines to produce all-ceramic patient specific dental restorations - full contour crowns and bridges for anterior and posterior location - as prescribed by a dentist. Type of Use {Select one or both, as applicable) Presaiption Use (Part 21 CFR 801 Subpart D) O Over-The-Counter Use (21 CFR 801 Subpart C) CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies ONIV 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 sowces, 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 Paperwort Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov · An agency may not conduct or sponsor, and a pen;on is not tequired to respond to, a collection of information unless it displays a cui'TefJtly valid OMB number." {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows a logo with a stylized letter 'T' at the center. The 'T' is depicted in a solid, dark color, giving it a bold appearance. Encircling the 'T' are orbital paths, reminiscent of an atom's structure, with small, dark circles representing electrons. To the right of the 'T', there is a 'TM' symbol, indicating that the logo is trademarked. # 510(k) SUMMARY | Date: | September 13, 2016 | |---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Sponsor: | Talladium's Inc.<br>27360 W. Muirfield Lane, Valencia, CA, 91355<br>P: (661) 295-0900 F: (661) 295-0895 | | Contact Person: | Edward R. Harms | | Trade Name: | Luminesse Shaded Zirconia SZ | | Common Name: | Porcelain Powder for Clinical Use | | Device Classification: | Class II | | Classification Number: | 21 CFR 872.6660 | | Classification Panel: | Dental | | CDHR Product Code: | EIH | | Indications for Use: | Luminesse Shaded Zirconia SZ blanks/discs are indicated for use<br>with CAD/CAM technology or manual milling machines to<br>produce all-ceramic patient specific dental restorations - full<br>contour crowns and bridges, for anterior and posterior location -<br>as prescribed by a dentist. | | Device Description: | Luminesse Shaded Zirconia SZ are used for full contour zirconia<br>dental restorations utilizing CAD/CAM system for design and<br>manufactured. Once designed and manufactured, Luminesse<br>Shaded Zirconia SZ will undergo sintering. The shaded zirconia<br>products are pre-shaded to meet all 16 VITA® shading guide;<br>hence, no further coloring is necessary post-sintering. Once<br>sintered, Luminesse Shaded Zirconia SZ will exhibit maximum<br>strength for posterior and anterior dental restorations. | | Non-clinical Performance: | The functionality of Luminesse Shaded Zirconia SZ and their<br>conformance to design input was assessed based on physical | {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows a logo with a stylized letter 'T' at its center. The 'T' is depicted in a solid, dark color, giving it a bold appearance. Encircling the 'T' are orbital paths, reminiscent of an atomic model, with small, dark circles representing electrons or particles along these paths. The overall design suggests a blend of technology and scientific concepts, possibly representing a company or organization involved in technological innovation or scientific research. > performance testing (flexural strength, shading consistency and coefficient of thermal expansion – CTE) in accordance with ISO 6872:2008. In addition, biocompatibility information on cytotoxicity, sensitivity and irritation is based upon a biocompatibility assessment conducted in accordance with ISO 10993-1: Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management. Per ISO 10993-1, Luminesse Shaded Zirconia SZ is considered a permanent contact mucosal membrane surface device. Biocompatibility testing was not performed since identical materials are used in the predicate device with the same type and duration of patient contact. Our device is comprised of identical materials and manufacturing methods as the predicate device and other legally marketed devices and does not introduce any new issues. Substantial Equivalence: The table below compares key characteristics that provide similarities and differences of the predicate device BruxZir™ Shaded (K130924) and the proposed device, Luminesse Shaded Zirconia SZ. If there are any differences between the predicate and proposed devices, they are with respect marketable disc dimensions and they are manufactured to be used exclusively with Sirona's milling system (Cerec and inLab MC XL milling machines). These differences do not introduce any new issues. Both the proposed device, Luminesse Shaded Zirconia SZ, and the predicate device BruxZir™ Shaded (K130924) consist of general porcelain powder material, have the same indication for use and are made following similar manufacturing methods in the industry. {5}------------------------------------------------ Image /page/5/Picture/0 description: The image is a logo that features a stylized letter 'T' at the center, with elements resembling an atomic model surrounding it. The 'T' is depicted in a solid, dark color, giving it a bold and prominent appearance. Orbit-like lines encircle the 'T', each containing a small, dark circle, which are reminiscent of electrons in an atomic structure. The overall design suggests a connection to technology, science, or innovation, with the atomic model adding a layer of sophistication and modernity to the logo. ### Lumi nes s e® Shaded Zi rc oni a and B r uxzi r ™ Shaded C ompar i s on T abl e | Company | Talladium Inc. | Prismatik DentalCraft, Inc. | |--------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) Number | Luminesse Shaded Zirconia<br>SZ<br>(K152023) | BruxZir™ Shaded<br>(K130924) | | Indication for Use | Luminesse Shaded Zirconia<br>SZ blanks/discs are indicated<br>for use with CAD/CAM<br>technology or manual milling<br>machines to produce all-<br>ceramic custom dental<br>restorations - full contour<br>crowns and bridges, for<br>anterior and posterior location<br>- as prescribed by a dentist. | The device is indicated for use by<br>dental technicians in the<br>construction of custom made all<br>ceramic restorations for anterior<br>and posterior location.<br>(While the Indication for Use<br>statement is not identical to that of<br>the proposed device, the difference<br>in wording does not raise any<br>concerns or issues about the use of<br>the proposed device). | | Product Information<br>(quantities, types) | Over 50 options in disc and<br>block shapes for different<br>milling systems. | About 25 different options in discs<br>for Sirona's milling system. | | Dimensions | Disc: 95 and 98 mm diameter<br>discs per 10mm, 12mm,<br>14mm, 16mm, 18mm, 22mm,<br>25mm and 30mm thicknesses.<br>Blocks: | 98.5 and 100 mm diameter discs<br>per 12mm, 15mm, 20mm and<br>25mm thicknesses. | | | For Amann Girrbach (milling<br>system): | | | | 89mm x 71mm x (10mm,<br>12mm, 14mm, 16mm, 18mm,<br>20mm, 22mm, 25mm); | | | | For Custom for Lava | | | | 72mm x 42mm x (10mm,<br>12mm, 14mm, 16mm, 18mm,<br>20mm, 22mm, 25mm); | | | | For Sirona inLab: | | | | 15mm x 20mm x (14mm and<br>19mm); | | | | 40mm x 15mm x (14mm and<br>19mm); | | | | 55mm x 19mm x 16mm; | | | | 65mm x 25mm x 22mm. | | | VITA® Shade | All 16 VITA® shades | All 16 VITA® shades | {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows a logo with a stylized letter 'T' at the center. The 'T' is depicted as a solid, dark shape. Orbiting around the 'T' are elliptical paths, reminiscent of atomic orbitals, with small, dark circles representing electrons or particles. The logo has a futuristic or scientific feel due to the atomic orbital design. {7}------------------------------------------------ Image /page/7/Picture/0 description: The image is a black and white logo. The logo features a stylized letter "T" in a bold, sans-serif font. The "T" is positioned in the center of the logo and is oriented vertically. Encircling the "T" are three elliptical orbits, reminiscent of an atomic model. Each orbit has a solid black circle, resembling an electron, positioned along its path. To the right of the base of the "T", there is a "TM" symbol, indicating a trademark. # Summary of Performance Tests – Talladium Shaded ZR | PERFORMANCE<br>TESTS | Talladium's Shaded<br>ZR<br>(K152023) | BruxZirTM Shaded<br>(K130924)<br>Predicate device | Similarities and<br>Differences | |----------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Flexural<br>Strength | Average: > 1,000 MPa<br>ISO 6872<br>requirements:<br>><br>800 MPa | Average: 1000 - 1200<br>MPa<br>Maximum: 1465 MPa | The flexural strength for<br>both proposed and<br>predicate devices are<br>slightly different, but both<br>meet minimum ISO 6872<br>requirement by over 30%,<br>minimum.<br>Based on the values, the<br>similarities in flexural<br>strength indicate both<br>devices perform the same. | | Coefficient of<br>Thermal<br>Expansion | Average ≈ 10.3 x 10-6/K | Average ≈ 11 x 10-6/K | The difference in the<br>coefficients of thermal<br>expansion between<br>proposed and predicate<br>devices are negligible.<br>The negligible difference<br>in CTEs show they will<br>behave very similarly<br>during CAD/CAM<br>machining. | | Vickers<br>Hardness | Average ≈ 52 (H.V.) | Average ≈ 49 (H.V.) | A small difference in<br>Vickers's hardness of 3 is<br>reported based on<br>comparison of average<br>values between predicate<br>and proposed devices. | | | | | This small difference in<br>Vickers's hardness does<br>not impact performance. | | Density | >6.05 g/cm³ (sintered) | 5.90 g/cm³ | Within experimental error,<br>the dimensions between<br>proposed and predicate<br>devices are similar.<br>The minor difference in<br>density does not impact<br>the performance of the<br>proposed device compared<br>to predicate. | | Chemical<br>Composition:<br>ZrO2+HfO2+Y2<br>O3+Al2O3 | >90% | >90% | The chemical composition<br>with relation to the major<br>chemical makeup are<br>identical between<br>proposed and predicate<br>devices. | | Biocompatibility<br>Assessment (per<br>ISO 10993-1) | Biocompatibility tests<br>were not performed.<br>However, a<br>biocompatibility final<br>assessment was<br>performed, in a<br>systematic approach, in<br>accordance with ISO<br>10993-1. This<br>concludes that the<br>following<br>biocompatibility<br>conclusions can be<br>achieved: | Bruxzir Shaded was<br>tested for Cytotoxicity,<br>Sensitization and<br>Irritation. The tests show<br>the following results: | Since the proposed device<br>is made of same material<br>(classified as porcelain<br>powder) as the predicate<br>device and have similar<br>manufacturing and type of<br>body contact properties,<br>and, in addition, predicate<br>device manufacturer has<br>performed<br>biocompatibility tests, we<br>concluded using our<br>medical device design<br>validation and verification | | Cytotoxic<br>(IX MEM<br>extraction) | Expected<br>to<br>meet<br>requirement. | PASS | process (which includes<br>FMEA and scientific and<br>clinical literature review)<br>that the proposed device | | method at<br>37°C)<br>Sensitization<br>(ISO<br>Intracutaneous<br>Study, Extract<br>0.9% sodium<br>chloride USP<br>solution (SC)<br>and sesame oil,<br>NF (SO)) | Expected to meet<br>requirement. | PASS | biocompatibility<br>performance is similar to<br>predicate device. | | Irritation and<br>Skin<br>Sensitization<br>Study, Extract<br>0.9% sodium<br>chloride USP<br>and sesame oil,<br>NF (SO)) | Expected to meet<br>requirement. | PASS | | {8}------------------------------------------------ Image /page/8/Picture/0 description: The image is a logo that features a stylized letter 'T' at the center, with an atomic symbol surrounding it. The 'T' is depicted in a solid, dark color, giving it a bold and prominent appearance. The atomic symbol consists of elliptical orbits with small, dark circles representing electrons, creating a sense of science or technology. {9}------------------------------------------------ Image /page/9/Picture/0 description: The image is a black and white logo. The logo features a stylized letter "T" in the center, with a three-dimensional appearance. Orbiting around the "T" are elliptical paths, each containing a solid black circle, resembling an atom model. To the right of the "T" is the "TM" symbol, indicating a trademark. Conclusion: Based upon the chemical composition, non-clinical performance testing and comparison of technology with the predicate device, the subject device is substantially equivalent to the predicate device, Bruxzir Shaded.