Dental Ceramic Blocks

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March 8, 2023 Aidite (Qinhuangdao) Technology Co., Ltd % Julie Chen Consultant ICAS Group 155 Pingbei Rd.Minghang Shanghai, Shanghai 201100 CHINA Re: K223742 Trade/Device Name: Dental Ceramic Blocks Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: Class II Product Code: EBF Dated: December 7, 2022 Received: December 29, 2022 Dear Julie Chen: 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/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 mediation-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. # Michael E. Adjodha -S Michael E. Adjodha, M.ChE. Assistant Director DHT1B: Division of Dental and ENT 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 Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below. 510(k) Number (if known) K223742 ### Device Name Dental Ceramic Blocks Indications for Use (Describe) Dental Ceramic Blocks are indicated for fabrication of inlays onlays, aminate veneers, anterior and posterior full crown restorations, and implant crowns and bridges by dental professionals and manufacturers using a dental CAD/CAM system. Type of Use (Select one or both, as applicable) > 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." FORM FDA 3881 (7/17) {3}------------------------------------------------ # K223742 510(K) Summary #### I. SUBMITTER: Aidite (Qinhuangdao) Technology Co., Ltd No.9 Dushan Road, Economic and Technological Development Zone,Qinhuangdao City China Contact Person: Chen Yingying Title: Registered Engineer Tel: 15033560085 Email: chenyingying@aidite.com Submission Correspondent: Julie Chen Email: c1.julie@hotmail.com Tel:+86 139 1804 5781 Summary prepared:02/27/2023 #### II. DEVICE Name of Device: Dental Ceramic Blocks Regulation Number: 21 CFR PART 872.3690 Classification Name: Material, tooth shade, resin Regulatory Class: II Product Code: EBF #### III. PREDICATE DEVICE Primary predicate device: K222723(AMBARINO High-Class) {4}------------------------------------------------ #### DEVICE DESCRIPTION IV. Dental Ceramic Blocks consist of methacrylate, benzoyl peroxide, barium glass powder and pigmen to form a solid block of material. The unique marriage of the materials creates a dual-network hybrid, which lends the positive physical properties of each individual material to the other. This non-sterile material is milled in a dental CAD/CAM machine into restorative form for single patient use. Dental Ceramic Blocks is provided as non-sterile. | Model | Shade | Specification | |---------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Monochromatic | A1-HT, A2-HT, A3-HT,<br>A3.5-HT, A4-HT, B1-HT,<br>B2-HT, B3-HT, B4-HT,<br>C1-HT, C2-HT, C3-HT,<br>C4-HT, D2-HT, D3-HT,<br>D4-HT, BL1-HT, BL2-HT,<br>BL3-HT, BL4-HT | Disc shape: 16×16, 20×20, 98×10,<br>98×12, 98×14, 98×16, 98×18, 98×20,<br>98×22, 98×25, 98×28, 98×30,95×10,<br>95×12, 95×14, 95×16, 95×18, 95×20,<br>95×22, 95×25, 95×28, 95×30 (Unit: mm) | | | | Horseshoe: 92×75×12、92×75×14、<br>92×75×15、92×75×16、92×75×18、<br>92×75×20 (Unit: mm) | | Multi-Layered | A1-LT, A2-LT, A3-LT, A3.5-LT,<br>A4-LT, B1-LT, B2-LT, B3-LT,<br>B4-LT, C1-LT, C2-LT, C3-LT,<br>C4-LT,D2-LT, D3-LT, D4-LT,<br>BL1-LT, BL2-LT, BL3-LT,<br>BL4-LT | Rectangle: 55×15.5×19 、<br>55×15.5×14、40×15×14、40×15×15、<br>40×15×19、32×15×15、29×15×14、<br>20×12×12、20×15×14、20×15×19、<br>18×16×18 、 18×14.5×14.5 、<br>18×13×15、18×14×12、15.5×11×13、<br>15×8×8、 15×10×8、 15×12×10、<br>14×12×10 (Unit: mm) | | | | | #### V. AVAILABLE MODEL #### VI. INTENED USE per 21CFR 807.92(A)(5) Dental Ceramic Blocks are indicated for fabrication of inlays/onlays, laminate veneers, anterior and posterior full crown restorations, and implant crowns and bridges by dental professionals and manufacturers using a dental CAD/CAM system. {5}------------------------------------------------ #### INDICATIONS for USE VII. Dental Ceramic Blocks are indicated for fabrication of inlays/onlays, laminate veneers, anterior and posterior full crown restorations, and implant crowns and bridges by dental professionals and manufacturers using a dental CAD/CAM system. ## VIII. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE Dental Ceramic Blocks are compared with the predicate device, AMBARINO High-Class (K222723). The results are shown below in the Technological Characteristics Comparison Table: | Item | Proposed Device | Predicate Device | Remark | |-------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------| | | Dental Ceramic Blocks | AMBARINO® High-Class | | | K number | TBD | K222723 | -- | | Regulation Number | 21 CFR PART 872.3690 | 21 CFR PART 872.3690 | SE | | Product Code | EBF | EBF | SE | | Common name | Material, tooth shade, resin | Material, tooth shade, resin | SE | | Classification | II | II | SE | | Manufacturer | Aidite (Qinhuangdao)<br>Technology Co., Ltd | Creamed GmbH & Co. Produktions-<br>und Handels KG | -- | | Intended Use | Dental Ceramic Blocks are<br>indicated for fabrication of<br>inlays/onlays, laminate<br>veneers, anterior and posterior<br>full crown restorations, and<br>implant crowns and bridges by<br>dental professionals and<br>manufacturers using a dental<br>CAD/CAM system. | AMBARINO® High-Class is indicated<br>for fabrication of inlays / onlays,<br>laminate veneers, anterior and posterior<br>full crown restorations, and implant<br>crowns and bridges by<br>dental professionals and manufacturers<br>using a dental CAD/CAM system. | SE | | Type Use | Prescription (Rx Only) | Prescription (Rx Only) | SE | | Physical State | Cured blocks and discs in a<br>variety of shapes and shades | Cured blocks and discs in a variety of<br>shapes and shades | SE | | Shapes | Disc Shape and Retangle | Disc Shape and Retangle | SE | | Structure | Polymer resin /ceramic hybrid<br>composite | Polymer resin /ceramic hybrid<br>composite | SE | | Color | Color | Color | SE | {6}------------------------------------------------ | Materials | UDMA, TEGDMA , EGDMA<br>BPO, 72% Barium glass<br>powder, Gaseous silica,<br>TiO2, Fe2O3, Fe2O3·H2O,<br>Fe3O4 | 39% UDMA, TEGDMA<br>61% inorganic<br>silica-based glass and<br>silica | Note 1 | |-------------------|--------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------|--------| | Dimension | Various | 14, 98 | Note 2 | | Flexural Strength | 207 MPa | 191 MPa | Note 3 | | Radioactive | 2.3mm Al | 1.8mm Al | Note 3 | | Biocompatibility | Conforms with<br>ISO 10993-1, FDA Guidance | Conforms with<br>ISO 10993-1, FDA Guidance | SE | | Performance | Conforms with<br>ISO 4049 | Conforms with<br>ISO 4049 | SE | | Sterility | Non-Sterile | Non-sterile | SE | | Single Use | Single Use | Single Use | SE | ## Discussion ## Note 1 Material Although the material of the proposed device and the predicate device is different, they meet the requirement of ISO 10993-1 and FDA guidance. ### Note 2 Dimension & Note 3 Flexural Strength and Radioactive The performance testing of the proposed device and the predicate device is complied with ISO 4049 and ISO 7491. Although the results have slightly difference, they meet the acceptance criteria. Therefore, this difference is considered not to affect the Substantially Equivalency (SE) between the proposed and predicate devices. #### IX. PERFORMANCE DATA ## Non-Clinical Performance Test Conclusion ### Biocompatibility Biocompatibility testing was performed on the proposed device in accordance with the following standards: - . ISO 10993-5:2009 Biological evaluation of medical devices- Part 5: Test for in vitro cytotoxicity - . ISO 10993-10:20101Biological evaluation of medical devices- Part 10: Test for irritation and delayed-type hypersensitivity {7}------------------------------------------------ - ISO 10993-11:2017 Biological evaluation of medical devices Part 11: Tests . for systemic toxicity - ISO 10993-6 : 2016 Biological evaluation of medical devices -- Part 6: Tests for local effects after implantation - . ISO 10993-3 : 2014 Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity, and reproductive toxicity ## Performance Bench Testing The basic safety and essential performance comparison test were evaluated based on as following standards: - ISO 4049, Dentistry - Polymer-based Restorative Materials - ISO 7405, Dentistry Evaluation of biocompatibility of medical device used in . dentistry ### Animal Study Animal testing was not required for this submission. ### Clinical Studies No clinical study is included in this submission. #### CONCLUSIONS X. The conclusions drawn from the nonclinical tests demonstrate that the proposed device is as safe, as effective, and performs as well as or better than the legally marketed predicate device AMBARINO High-Class (K222723).