Dental Ceramic

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May 22, 2019 Baot Biological Technology Co., LTD Ligun Zhu Quality Manager Unit 1, Second Floor, No 12 Building, Yujing Industry Zone, 106 Qihao Road, Torch Development District Zhongshan, 528437 CHINA Re: K182350 Trade/Device Name: Dental Ceramic Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain powder for clinical use Regulatory Class: Class II Product Code: EIH Dated: February 21, 2019 Received: February 21, 2019 Dear Liqun Zhu: 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. {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 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, for Malvina Eydelman, M.D. Director OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K182350 Device Name Dental Ceramic (Model: Metal Ceramic; Zirconia Ceramic) Indications for Use (Describe) Dental Ceramic is indicated for use for metal-ceramic full veneers and for zirconia full veneers and partial veneers. | 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) #### 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 # K182350 ## 1. Submitter's Information The submitter of this pre-market notification is: | Name: | BAOT BIOLOGICAL TECHNOLOGY CO.,LTD | |------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------| | Address: | Unit 1, Second Floor, No 12 Building, Yujing Industry<br>Zone, 106 Qihao Road, Torch Development District,<br>Zhongshan City, Guangdong, P.R. China | | | Zip Code: 528437 | | Company Phone No: | +86 760 87893826 | | Company Fax No: | +86 760 87893827 | | Contact Person: | Liqun Zhu | | E-mail: | baotw@baot.biz | | Date summary prepared: | August 10, 2018 | ## 2. Device Identification | Device Trade Name: | Dental Ceramic (Model: Metal Ceramic; Zirconia<br>Ceramic) | |---------------------|------------------------------------------------------------| | Classification Name | powder, porcelain | | Regulation Number: | 21 CFR 872.6660 | | Regulation Name: | Porcelain Powder For Clinical Use | | Regulation Class: | II | | Product Code: | FIH | {4}------------------------------------------------ # 004 510(k) summary #### 3. Predicate Devices | Device Trade Name: | Luminesse Porcelain System | |-----------------------|-----------------------------------| | 510(k) Number; | K140848 | | Regulation Name: | Porcelain Powder For Clinical Use | | Class: | II | | Classification Panel: | Dental | | Product Code: | EIH | | Regulation Number: | 21 CFR 872.6660 | #### 4. Device Description Dental Ceramic divided into two categories: Metal Ceramic; Zirconia Ceramic. They are used to be made for simulation tooth of human whose ages above 18. After fired, form the whole or part of a dental restoration or prosthesis. It is made by Aluminium oxide(Al2O3), Silicon dioxide (SiO2), Potassium carbonate (K2CO3), Sodium carbonate (Na2CO3), Calcium oxide (CaO), Zirconium dioxide (ZrO2), Metal Ceramic :a complete metallic substructure of Dental Ceramic are Glaze separated two parts-metal and ceramic, which is made of metal alloys and whose inner is a framework. The materials within the metallic is broadly divided into three categories: precious metal, semiprecious metal alloys and non-precious metal alloys, being usually called inner alloy crown. Zirconia Ceramic : A complete Zirconia Ceramics are separated two parts-Zirconia coping and porcelain layer (Dentin layer and Enamel layer), as shown in the figure, the innermost layer of dental ceramic is Zirconia coping which is a framework. It has a positive impact on bearing and combining closely with the dentin layer. #### 5. Intended Use / Indications for Use Dental Ceramic is indicated for use for metal-ceramic full veneers and partial veneers and for zirconia full veneers and partial veneers. ### 6. Substantial Equivalence A comparison of the relevant technological characteristics between the subject and primary predicate devices is provided in the table that follows. {5}------------------------------------------------ # 004_510(k) summary | Feature | Our device | Luminesse Porcelain (K140848) | Comments | |---------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications For<br>Use: | Dental Ceramic is<br>indicated for use for<br>metal-ceramic full veneers<br>and partial veneers and<br>for zirconia full veneers<br>and partial veneers. | The Luminesse Porcelain System<br>is dental porcelain material to be<br>used in conjunction with metal,<br>zirconia, or pressable ceramic<br>framework in the construction of<br>crowns and/or bridgework and<br>veneers. | Different<br>The description of the<br>intended use is<br>different, but it is the<br>same as product<br>form, the actual use<br>and methods, and the<br>change of descrption<br>for IFU does not<br>cause unknown<br>safety problems. | | Chemical<br>composition | Aluminium oxide(Al2O3),<br>Silicon dioxide (SiO2),<br>Potassium carbonate<br>(K2CO3), Sodium<br>carbonate (Na2CO3),<br>Calcium oxide (CaO),<br>Zirconium dioxide (ZrO2) | Equivalent devices are compared<br>with predicate products<br>(K981490), the comments shows<br>that Most all oxides are present in<br>both Luminesse High-Fusing and<br>Willi Geller Creation CC porcelain,<br>it included varying proportions of<br>silicon dioxide, aluminum dioxide,<br>sodium oxide, potassium oxide,<br>tin oxide, barium oxide and iron<br>oxide. Chemically stable mixed<br>metal oxides, including spinel,<br>baddeleyit, zircon, and periclase<br>phases of zirconium, iron, cobalt,<br>chromium, yttrium, cerium, nickel<br>and zinc oxides, are used in trace<br>amounts for pigmentation. The<br>paste opaques are comprised of<br>ceramic powder fitting this<br>description suspended in glycerol,<br>zinc chloride, sodium acetate,<br>propandiol, and aerosol. The<br>stains are composed of silicon<br>dioxide, aluminum oxide, potassium<br>oxide, tin oxide, barium oxide, | Different<br>The predicate device<br>state that it included<br>varying proportions of<br>silicon dioxide,<br>aluminum dioxide,<br>sodium oxide,<br>potassium oxide, tin<br>oxide, barium oxide<br>and iron oxide.<br>We performed<br>Biocompatibility test<br>and ISO 6872 test,<br>the test result shows<br>that Components of<br>our product met<br>requirements of<br>biocompatibility and<br>performance. The<br>difference does not<br>cause unknown<br>safety problems. | | | | iron oxide, and calcium oxide, and<br>chemically stable mixed metal<br>oxides for pigmentation. | | | Classification<br>Code | 21 CFR 872.6660<br>Product Code: EIH | 21 CFR 872.6660<br>Product Code: EIH | Same | | Flexural<br>strength | METAL CERAMIC<br>OPAQUE :98.63MPa<br>DENTINE :98.07Mpa<br>ENAMEL :102.48Mpa<br>ZIRCONIA CERAMIC<br>DENTINE :92.56MPa<br>ENAMEL :98.87MPa | Met the requirements of ISO 6872 | The predicate<br>device(K140848) do<br>not list the main<br>technological<br>characteristic in the<br>510(k) summary, it<br>just state that Bench<br>testing to determine<br>flexural strength,<br>solubility, and glass | | Solubility | METAL CERAMIC<br>OPAQUE :15.88µg.cm-2<br>DENTINE :36.77µg.cm-2<br>ENAMEL :18.40µg.cm-2<br>ZIRCONIA CERAMIC<br>DENTINE :18.17µg.cm-2<br>ENAMEL :28.60µg.cm-2 | Met the requirements of ISO 6872 | transition temperature<br>was conducted in<br>accordance with ISO<br>6872.<br>We also performed<br>the bench test in<br>accordance with ISO<br>6872. The test results<br>can prove our product<br>met the requirements | | Glass transition<br>temperature | METAL CERAMIC<br>OPAQUE :575°C<br>DENTINE : 575°C<br>ENAMEL : 575°C<br>ZIRCONIA CERAMIC<br>DENTINE : 590°C<br>ENAMEL : 590°C | Met the requirements of ISO 6872 | of ISO 6872, we think<br>the lack of<br>performance data of<br>predicate device do<br>not does not cause<br>unknown safety<br>problems. | | Biocompatibility | Met the requirements of<br>ISO 10993-1,-3,-5,-10,-11,<br>USP40<151> | Components of this product have<br>not changed in any way from the<br>predicate that would adversely<br>affect biocompatibility; therefore, | Different<br>We performed ISO<br>10993 test to prove | | | it is determined that no<br>biocompatibility testing is<br>necessary for this product. | our product's<br>biocompatibility. | | {6}------------------------------------------------ # 004_510(k) summary {7}------------------------------------------------ ## 7. Biocompatibility Testing Our product belong to external communicating device which contact dentin more than 30 days, we have conducted biological evaluations based on the requirements of ISO 10993-1 and other similar dental materials, as below : - Ames Test ISO 10993-3 Biological evaluation of medical devices Part 3: Tests for i genotoxicity, carcinogenicity and reproductive toxicity. - -In Vitro Cytotoxicity Test - ISO 10993-5 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity - -Oral MucOsa Irritation - ISO 10993-10 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization - -Skin sensitization - ISO 10993-10 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization - Pyrogen Test ISO 10993-11 and USP40<151>Biological evaluation of medical devices -- Part 11: Tests for systemic toxicity - -Acute systemic Toxicity Test - ISO 10993-11 Biological evaluation of medical devices -Part 11: Tests for systemic toxicity - Subchronic systemic Toxicity Test ISO 10993-11 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity ### 8. Performance testing : Performance testing was conducted in accordance with ISO 6872:2008 Dentistry - Ceramic materials. The Dental Ceramic is classified as a Type I, Class 1 device and met the standard requirements per ISO 6872:2015. We also provided a comparison between ISO 6872:2008 and ISO 6872:2015, effects of changes to materials properties. #### 9. Conclusions: It has the same technological characteristics, manufacturing process, and similar intended use, chemical composition, as the predicate devices. Our products are substantially equivalent as its predicate device.