Shaders ZR

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. July 29, 2019 Digital Age Dental Lab Tim Mckimson International Project Manager 2110 Artesia Blvd. Ste. B-132 Redondo Beach, California 90278 Re: K190569 Trade/Device Name: Shaders ZR Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: Class II Product Code: EIH Dated: April 22, 2019 Received: April 22, 2019 Dear Tim Mckimson: 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 {1}------------------------------------------------ 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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Srinivas Nandkumar, Ph.D. Acting Assistant Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration ### Indications for Use 510(k) Number (if known) K190569 Device Name Shaders™ Zirconia ### Indications for Use (Describe) Shaders™ Zirconia blanks are indicated for use in prosthetic dentistry to creatic) prostheses (dentures, crowns, and bridges). Shaders™ Zirconia blanks are intended to be milled and fully sintered by a dental laboratory before use. Full contour monolithic crowns and bridges in anterior and posterior regions. Type of Use (Select one or both, as applicable) X 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) {3}------------------------------------------------ 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." {4}------------------------------------------------ ## K190569 Page 11 of 82 July 10, 2019 ## 510(k) Summary ### for ## Digital Age Dental Laboratories ### Shaders™ Zirconia #### Submitter 1. Digital Age Dental Laboratories 3I A Dan Chu Street, VSIP 2, Hoa Phu Ward, Thu Dau Mot City, Binh Duong Province, Vietnam Phone: +84-650-3628 100 Fax: +84-650-3628 104 Contact Person: Tim McKimson Email: TMcKimson@fishmandentallabs.com #### 2. Device Name | Proprietary Name: | Shaders™ Zirconia | |----------------------|------------------------------------| | Common/Usual Name: | Powder, Porcelain | | Classification Name: | Porcelain powder for clinical use. | | Regulation Number: | 21 CFR 872.6660 | | Regulation Name: | Porcelain Powder for Clinical Use | | Regulation Class: | II | | Product Code: | EIH | {5}------------------------------------------------ #### 3. Predicate Device: Device Trade Name: Glidewell Prismatik™ Clinical Zirconia (Prismatik™ CZ) | 510 (k): | K062509 | |----------------------|------------------------------------| | Common/Usual Name: | Powder, Porcelain | | Classification Name: | Porcelain powder for clinical use. | | Regulation Number: | 21 CFR 872.6660 | | Regulation Name: | Porcelain Powder for Clinical Use | | Regulation Class: | II | | Product Code: | FIH | ### Indications for Use 4. Shaders™ Zirconia blanks are indicated for use in prosthetic dentistry to create porcelain (ceramic) prostheses (dentures, crowns and bridges). Shaders™ Zirconia blanks are intended to be milled and fully sintered by a Dental Professional or Dental Laboratory before use. Full contour monolithic crowns and bridges in anterior and posterior regions. #### 5. Device Description and Function Shaders™ Zirconia are disc shaped dental porcelain zirconia oxide blanks that come in different sizes that are used in custom restorations by the dental laboratory. The dental laboratory will further process the blank by milling the blank based upon the anatomically rendering of the patient's teeth (done at the dental {6}------------------------------------------------ office) through "Computer Aided Drafting/ Computer Aided Machining (CAD/CAM)". Once the custom rendered blank is milled the product is fully sintered and colored (if required) and fitted to the patient's teeth as dentures, crowns or bridges. ### 6. Substantial Equivalence A comparison of the relevant technological characteristics between the subject and primary predicate devices is provided in the table that follows: | Feature | Shaders™ Zirconia | Prismatik™ CZ | Comment | |---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------| | Indications<br>for use | Shaders™ Zirconia blanks are indicated for use in prosthetic dentistry to create porcelain (ceramic) prostheses (dentures, crowns and bridges). Shaders™ Zirconia blanks are intended to be milled and fully sintered by a Dental Professional or Dental Laboratory before use. Full contour monolithic crowns and bridges in anterior and posterior regions. | The device is indicated for use by dental technicians in the construction of custom made all ceramic restorations for anterior and posterior locations. | No change | | Feature | Shaders™ Zirconia | Prismatik™ CZ | Comment | | Contra-<br>Indications | There are no specific<br>precautions, warnings or<br>contra-indications that are<br>required for the safe and<br>effective use of the device<br>by the dental professional<br>or patient. | There are no specific<br>precautions, warnings<br>or contra-indications<br>that are required for<br>the safe and effective<br>use of the device by<br>the dental professional<br>or patient. | Same | | Material<br>Composition | Zirconia Powder: | Zirconia Powder: | Same | | | ZrO2+HfO2 + Y2O3 | ZrO2+HfO2+Y2O3 | | | | HfO2 | HfO2 | | | | Y2O3 | Y2O3 | | | | Al2O3 | Al2O3 | | | | Other oxides | Other oxides | | | | | | | | Freedom from<br>extraneous<br>materials per<br>ISO 6872:2008<br>Section 5.2<br>active conc. of<br>not more than<br>$1.0 Bq g^{-1}$ of<br>Uranium238 | <0.03 | Not supplied | Passed test | | Sintered<br>Density<br>$g/cm^{-3}$<br>No req't. | $6.09 g/cm^{-3}$ | Not supplied | No req't | | | | | | | Coefficient of<br>thermal<br>expansion<br>(CTE) | $10.1 \mu m/m$ °C | Not supplied | Both Materials<br>are 3m% and<br>will have the<br>same density | | Feature | Shaders™ Zirconia | Prismatik™ CZ | Comment | | Fracture<br>toughness<br>KIC | 5 MPa m0.5 | 5.0 MPa m0.5 | Same | | Flexural<br>strength per<br>ISO 6872:<br>2008, Limit<br>>900MPa | 1103 MPa | 1100MPa | Both close to<br>1100 mpa | | Chemical<br>solubility per<br>ISO<br>6872:2008<br>Limit 100<br>µg/cm² | 18.1 µg/cm² | Not supplied | Test passed | | Biocompatibility per ISO<br>10993-1: Part<br>1 - 'Biological<br>evaluation of<br>medical<br>devices –Part<br>1: Evaluation<br>and testing<br>within a risk<br>management<br>process." | Assured through use of<br>same materials and<br>manufacturing methods as<br>legally marketed predicate<br>devices. | "The biological safety<br>of the device has been<br>assured through the<br>selection of materials<br>similar in composition<br>to the other products<br>currently on the market<br>which have<br>demonstrated<br>appropriate levels of<br>biocompatibility (see<br>supra regarding<br>materials and labeling<br>for the device)." | Similiar<br>compositions<br>and<br>manufacturing<br>methods. | | Blank<br>sizes(mm) | Disc:<br>98.5-100mm x 10-30mm<br>thick | Disc:<br>98.5 x 10-30mm thick | Same | {7}------------------------------------------------ Page 14 of 82 {8}------------------------------------------------ Page 15 of 82 {9}------------------------------------------------ #### Physical and Performance Characteristics 7. ### Material Used: Shaders™ Zirconia blanks are composed of zirconia ceramics (ZrO2) based on yttria-stabilized tetragonal zirconia (Y-TZP). The material is biocompatible according to ISO 10993-1: 2009 "Biological Evaluation of medical devices – Part 1: Evaluation and testing within a risk management process". Physical Properties: Tabulated chart of finished product "Shaders™ Zirconia" blanks | Sintered Density | $\geq$ 6.09 g cm³ | |----------------------------------------------|-------------------| | Thermal Expansion coefficient (20-<br>500°C) | 10.1 µm/m °C | | Bending Strength | > 900 MPa | | Grain size | 0.45 µm | | Fracture toughness | 5 MPam0.5 | ### Chemical Properties: | Component (chemical<br>composition) | Shaders™ Zirconia (percentage by<br>wt.) | |-------------------------------------|------------------------------------------| | ZrO2 + HfO2 + Y2O3+ Al2O3 | > 99.9 | | Y2O3 | 5.35 - 5.95 | | Al2O3 | ≤0.1 | | SiO2 | ≤0.02 | | Fe2O3 | ≤0.01 | | Chemical solubility | 18.1 µg/cm² | {10}------------------------------------------------ #### 8. Nonclinical Testing Digital Age Dental Laboratories performed a series of tests to assess whether the device is safe and effective to use. Sintered tests coupled with mechanical bench testing confirmed that the device meets specifications including established international standards and guidance documents. Density, bending strength, fracture toughness, chemical solubility and material characterization/composition of finished product was conducted to confirm that the product is safe and effective, while meeting performance goals established by standards. Shaders™ Zirconia blanks comply with ISO 6872:2008, "Dentistry – Ceramic materials" and ISO 13356: 2008, "Implants for surgery, Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP)". #### 9. Clinical Testing Clinical tests have not been performed. - 10. Conclusion: Shaders™ Zirconia blank comparison to the predicate device Glidewell Prismatik™ Clinical Zirconia (Prismatik™ CZ K060104) is based upon similar characteristics such as: intended use, indications, contra-indications, material properties, chemical composition, processing/fabrication and testing to recognized standards and guidelines, Digital Age Dental believes that Shaders™ Zirconia blanks are substantially equivalent to these legally marketed predicate devices.