Zirdent Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square and the words "U.S. FOOD & DRUG ADMINISTRATION". November 12, 2021 Zirdent New Material Co., Ltd % Jinghua Zhou Regulation Control Manager Guangzhou Junyi Information Technology Co., Ltd. Room 304, Building A. No. 62 Nanyun 2nd Road, Science Town Huangpu District, Guangzhou City, Guangdong 510663 China Re: K212259 Trade/Device Name: Zirdent Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder For Clinical Use Regulatory Class: Class II Product Code: EIH Dated: August 18, 2021 Received: August 18, 2021 Dear Jinghua Zhou: 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 mav, 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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's {1}------------------------------------------------ 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-reporting- combination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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(@tda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, # Bobak Shirmohammadi -S For 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 Ouality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ #### Indications for Use 510(k) Number (if known) K212259 Device Name Zirdent Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank Indications for Use (Describe) Zirdent Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank are used for dental restorations using different CAD/ CAM or manual milling machines. All blanks are processed thought dental laboratories or by dental professionals. 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." {3}------------------------------------------------ #### Section 5 - 510(k) Summary #### K212259 Date of Summary Preparation: July 6, 2021 Date of Modification: August 13, 2021 #### 1. Submitter's Identifications Submitter's Name: Zirdent New Material Co., Ltd Address: No.101, 3rd building of Hai Ping International Medical Device Industrial Area, No.229, Guyuan Road, Hi-tech New District, Changsha, Hunan, China Zip Code: 410205 Contact Person: Jia Li Contact Title: General Manager Contact E-mail Address: 448658264@qq.com Tel: +86-731-85529297 Fax: +86-731-88995949 ## 2. Correspondent's Identifications Correspondent's Name: Guangzhou Junyi Information Technology Co., Ltd. Address: Room 304, Building A, No. 62 Nanyun 2nd Road, Science Town, Huangpu District, Guangzhou City, Guangdong, 510663, China ZIP Code: 510663 Contact Person: Jinghua Zhou Contact Title: Regulation Control Manager Contact E-mail Address: admanzhou@126.com Tel: +86-20-82329549 Fax: +86-20-82329549 #### 3. Name of the Device Device Classification Name: Powder, Porcelain Regulation Description: Porcelain powder for clinical use Trade Name: Zirdent Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank Model: HT-plus, ST, ST-C, ST-ML, SHT, SHT-C, SHT-ML, 3D-pro-ML, UT, UT-C, UT-ML Regulation Medical Specialty: Dental Review Panel: Dental Product Code: EIH Regulation Number: 21 CFR 872.6660 Device Classification: Class II ## 4. The Predicate Devices Primary Predicate device: K141724 Upcera Dental Zirconia Blank & Dental Zirconia {4}------------------------------------------------ Pre-Shaded Blank Liaoning Upcera Company Limited ## 5. Device Description Zirdent Dental Zirconia Blank are derived from zirconia powder that has been processed into their final shapes. These blanks are then being further fabricated into all-ceramic restorations such as crowns, bridges, veneers, inlay/onlay. The zirconia powder is composed of ZrO2+ Y2O3+ HfO2+ Al2O3 with its composition conforms to ISO 13356, Implants for surgery - Ceramic materials based on yttriastabilized tetragonal zirconia (Y-TZP). The performance of the dental blanks conforms to ISO 6872, Dentistry - Ceramic materials. Zirdent Dental Zirconia Pre-Shaded Blank are derived from the same Zirconia powder as the regular Zirdent Dental Zirconia Blank with the addition of very small amount of inorganic pigments before the composite material is processed into their final net shapes. These blanks are then being further fabricated into all-ceramic restorations such as crowns, bridges, veneers, inlay/onlay. The purpose of the inorganic pigments is to generate the color on the prosthetic dental devices, after sintering at dental labs, that matches natural color of patient's teeth. The performance of the dental blanks conforms to ISO 6872, Dentistry - Ceramic materials. #### 6. Intended Use of Device Zirdent Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank are used for dental restorations using different CAD/CAM or manual milling machines. All blanks are processed thought dental laboratories or by dental professionals. | | Proposed Device | Predicate device | Comparison | |------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------| | 510k Number | K212259 | K141724 | ------- | | Product Code | EIH | EIH | Same | | Proprietary Name | Zirdent Dental<br>Zirconia Blank &<br>Dental Zirconia<br>Pre-Shaded Blank | Upcera Dental<br>Zirconia Blank &<br>Dental Zirconia<br>Pre-Shaded Blank | ------- | | Model | HT-plus, ST, ST-C,<br>ST-ML, SHT,<br>SHT-C, SHT-ML,<br>3D-pro-ML, UT,<br>UT-C, UT-ML | ------- | ------- | | Manufacturer | Zirdent New<br>Material Co., Ltd | Liaoning Upcera<br>Company Limited | ------- | | Indications for<br>Use | Zirdent Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank are used for dental restorations using different CAD/CAM or manual milling machines. All blanks are processed thought dental laboratories or by dental professionals. | Upcera Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank are used for dental restorations using different CAD/CAM or manual milling machines. All blanks are processed thought dental laboratories or by dental professionals. | Same | | Basic design | Blocks, and rods | Blocks, disc, and rod | Same | | Materials | Regular:<br>Zirconia (ZrO2+ Y2O3+ HfO2+ Al2O3≥99.0%)<br><br>Pre-shaded:<br>Zirconia (ZrO2+ Y2O3+ HfO2+ Al2O3≥99.0%)<br><br>Inorganic pigments (Fe2O3, Er2O3 and MnO <2.0%) | Regular:<br>Zirconia (ZrO2+ Y2O3+ HfO2+ Al2O3≥99.0%)<br><br>Pre-Shaded:<br>Zirconia (ZrO2+ Y2O3+ HfO2+ Al2O3≥98.0%)<br><br>Inorganic pigments (Fe2O3, Pr2O3, and Er2O3 <2.0%) | Similar1 | | Processing | Sintering at temperature: > 1450°C | Sintering at temperature: > 1500°C | Similar2 | | Dimension | Various | Various | Same | | Single Use | Yes | Yes | Same | | Color | None, and Pre-shaded (for pre-shaded series) | None, and Pre-shaded (for pre-shaded series) | Same | | Sterile | Non-sterile | Non-sterile | Same | ## 7. Summary of Substantial Equivalence Table 1 Comparison to Predicate Device {5}------------------------------------------------ # Zirdent New Material Co., Ltd The proposed device is essentially identical to the predicate devices in terms of indication for use, design between our device and the predicate devices. The minor {6}------------------------------------------------ differences are that as below: Note 1: Zirconia (ZrO2+ Y2O2+ HfO2+ Al2O3) of proposed device which is not less than 99.0% is higher than that of the predicate device. The three inorganic pigments of the proposed device contain Fe203, Er2O3 and MnO, while those of the predicate device are Fe2O3, ProO3, and Er2O3. These are minor differences and the biocompatibility testing of the overall proposed device passed. Note 2: Processing (Sintering at temperature) of the proposed device is slightly lower 5°C than that of the predicate device. This is minor difference and the performance testing of the proposed device passed. #### 8. Summary of Non-Clinical Testing Bench testing was performed per ISO 6872:2015 and internal procedures to ensure that the Zirdent Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank met its specifications. All tests were verified to meet acceptance criteria. Test results on radioactivity, flexural strength, chemical solubility, linear thermal expansion coefficient, freedom from extraneous materials, uniformity, shrinkage factor, pre-sintered density, sintered density, and fracture toughness of the subject device are very similar to predicate device. Biocompatibility testing was performed to verify the equivalent safety of the materials that are used. According to ISO 10993-1:2018 and ISO ISO7405:2018, we evaluated and conducted the compatibility test for the proposed device. The following table shows the biocompatibility testing results. | Item | Proposed device | Result | |----------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------| | Cytotoxicity<br>(ISO 10993-5:2009) | Under the conditions of this study, the test article was non cytotoxic for 2 h and mildly cytotoxic for 24 h in the filter diffusion method.<br>Under the conditions of this study, the test article was accepted in the agar diffusion method.<br>Under the conditions of this study, the test article has no potential toxicity to L-929 cells. | Pass | | Oral Mucosa Irritation<br>(ISO 10993-10:2010) | The test article showed no evidence of causing oral mucosa irritation in the Syrian hamsters. | Pass | | Delayed Dermal<br>Contact Sensitization<br>(ISO 10993-10:2010) | The test article showed no evidence of causing delayed dermal contact sensitization in the guinea pig. | Pass | | Subacute Toxicity<br>(ISO 10993-11:2017) | The test article showed no evidence of causing acute system toxicity in the ICR mice. | Pass | | Subchronic Toxicity<br>(ISO 10993-11:2017) | The test results showed that the test article did not induce subacute systemic toxicity 28 days in rats and 90 days in rats under these conditions. | Pass | | Mutagenesis | Under the conditions of this study, the test article | Pass | Table 2 Biocompatibility testing {7}------------------------------------------------ ## Zirdent New Material Co., Ltd | (ISO 10993-3:2014) | is considered non-mutagenic.<br>Under the conditions of this study, the number of<br>reverting colonies in the test article group is not<br>equal to or greater than 2 times that of the<br>spontaneous control, so the test article have no<br>potential mutagenesis. | | |-----------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------| | Genotoxicity Toxicity<br>(ISO 10993-3:2014) | The test result showed that the extract of the test<br>article did not induce the potential genotoxicity<br>toxicity in ICR mice under this condition. | Pass | | Local Effects After<br>Implantation<br>(ISO 10993-6:2016) | The test result showed that the test article did not<br>induce local effects after implantation of<br>biomaterials in rabbits under this condition. | Pass | Note: Testing were Performed on pre-shaded zirconia blank (UT-C) to cover the regular and pre-shaded zirconia blanks. #### 9. Clinical Test Conclusion No clinical study is included in this submission. #### 10. Conclusion: The conclusions drawn from the nonclinical tests demonstrate that subject device Zirconia Blank & Dental Zirconia Pre-Shaded Blank performs as well as or better than the legally marketed predicate device K141724 Upcera Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank. Zirdent Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank is substantial equivalent to the legally marketed predicate device K141724 Upcera Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank.