Soreal Press, Soreal CAD

{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 and 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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. May 25, 2023 Shenzhen UP3d Technology Co., Ltd. Judy Zhang Head of Firm 401, Block B, Nanshan Yungu Nanfeng Tower 4093 Liuxian Avenue, Nanshan District Shenzhen, Guangdong 518055 CHINA Re: K230259 Trade/Device Name: Soreal Press, Soreal CAD Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder For Clinical Use Regulatory Class: Class II Product Code: EIH Dated: April 13, 2023 Received: April 25, 2023 Dear Judy Zhang: 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}------------------------------------------------ # Indications for Use 510(k) Number (if known) K230259 Device Name Soreal CAD Soreal Press #### Indications for Use (Describe) Soreal Press is indicated for single-unit anterior or posterior prostheses and for three-unit prostheses, such as veneers, inlay/onlay, partial crowns, anterior crowns, posterior crowns, using the hot press technique. Soreal CAD is indicated for single-unit anterior or posterior prostheses and for three-unit prostheses, such as veneers, inlay/onlay, partial crowns, anterior crowns, posterior crowns, using the CAD/CAM system. | Type of Use (Select one or both, as applicable) | |--------------------------------------------------------------------------------------------------------------------| | <div> <span> <span style="font-size:16px">☒</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | | <div> <span> <span style="font-size:16px">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> | #### 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}------------------------------------------------ Image /page/3/Picture/1 description: The image shows a logo with an orange geometric shape on the left and the text "云甲科技" on the right. The geometric shape appears to be a stylized representation of a cube or a series of interconnected boxes. The text is in Chinese characters, and the overall design is simple and modern. # 510(K) Summary - K230259 Prepared in accordance with the requirements of 21 CFR Part 807.92 #### Prepared Date: ## 1. Submitter's Information The submitter of this pre-market notification is: | Name: | Shenzhen UP3d Technology Co., Ltd. | |-----------------|-----------------------------------------------------------------------------------------------------| | Address: | 401, Block B, Nanshan Yungu Nanfeng Tower<br>4093 Liuxian Avenue, Nanshan District, Shenzhen, China | | Contact person: | Judy Zhang | | Title: | Head of Firm | | E-mail: | zhangwanlin@up3d.cn | | Tel: | 086-13713634397 | #### 2. Device Identification | Device/Trade Name: | Soreal Press/Soreal CAD | |--------------------|-------------------------| | Regulation Number: | 872.6660 | | Regulation Class: | Class 2 | | Product Code: | EIH | | Common Name: | Powder, Porcelain | # 3. Predicate Device | 510(K) number: | K192231 | |--------------------|-------------------------------------------| | Device Name: | Dental Glass Ceramics Blocks | | Manufacturer: | Aidite (Qinhuangdao) Technology Co., Ltd. | | Regulation Number: | 872.6660 | | Regulation Class: | Class 2 | | Product Code: | EIH | | Common Name: | Powder, Porcelain | #### 4. Device Description Our products are divided into Soreal Press and Soreal CAD. Soreal Press is put into the porcelain casting furnace and form it by hot pressing at 915-930 °C, and treatment by sandblasting and glazing. Soreal CAD is cut by grinding equipment with wet processing, and put into the porcelain casting furnace at 840-850°C for 30 min to secondary crystallization treatment. Then dye it. {4}------------------------------------------------ Image /page/4/Picture/1 description: The image contains a logo with an abstract geometric shape on the left and Chinese characters on the right. The logo and characters are both in orange color. The characters appear to be the name of a company or organization. They are all composed of SiO2, Li2O, K2O, P2O5, Al2O3 and other oxides. They have a variety of colors, and users can choose the right color to match the patient's natural teeth. In general, our products are also called Dental glass ceramic. #### 5. Indication for use Soreal Press is indicated for single-unit anterior or posterior prostheses and for three-unit prostheses, such as veneers, inlay/onlay, partial crowns, posterior crowns, using the hot press technique. Soreal CAD is indicated for single-unit anterior or posterior prostheses and for three-unit prostheses, such as veneers, inlay/onlay, partial crowns, anterior crowns, using the CAD/CAM system. {5}------------------------------------------------ Image /page/5/Picture/1 description: The image contains a logo and text. The logo is an abstract shape in orange. To the right of the logo is the text "云甲科技", also in orange. The text appears to be in Chinese. ## 6. Comparison to Predicate Device Compared to the predicate devices, the subject device has same intended use, similar product design, same performance effectiveness, performance safety as the predicate device as summarized in the following table | SE<br>Comparisons | Proposed Devices<br>K230259 | Predicate Device<br>K192231 | Similarities/<br>Differences | | |--------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------| | Name | Soreal Press | Dental Glass Ceramics<br>Blocks | / | | | Classification | Class 2 | Class 2 | Same | | | Indications for<br>Use | Soreal Press is<br>indicated for<br>single-unit<br>anterior or<br>posterior<br>prostheses and<br>for three-unit<br>prostheses, such as<br>veneers, inlay/onlay,<br>partial crowns,<br>anterior crowns,<br>posterior<br>crowns, using the<br>hot press technique. | Soreal CAD is<br>indicated for<br>single-unit<br>anterior or<br>posterior<br>prostheses and<br>for three-unit<br>prostheses, such as<br>veneers, inlay/onlay,<br>partial crowns,<br>anterior crowns,<br>posterior<br>crowns, using the<br>CAD/CAM system. | Dental Glass Ceramics<br>Blocks are indicated for<br>fabricating all-ceramic<br>restorations such as<br>veneers, inlay/onlay, partial<br>crowns, anterior crowns,<br>posterior crowns, using the<br>hot press technique or<br>CAD/CAM system | Similar Note 1 | | Materials | SiO2, Li2O,<br>K2O, P2O5,<br>Al2O3 and other<br>oxides | SiO2, Li2O, K2O, Al2O3 and<br>other oxides | Similar Note 2 | | | Processing at<br>Dental lab | Hot Press<br>(Soreal Press) | Hot Press (Up. Press<br>Series)<br>CAD/CAM (Up. CAD Series) | Same | | | Geometry | Cylinder | Blocks | Similar Note 3 | | | Dimension | Various | Various | Various | Same | | Single use | Yes | Yes | Yes | Same | | Available<br>color | Various | Various | Various | Same | | Sterile | Non-sterile | Non-sterile | Non-sterile | Same | | Uniformity | The colorants<br>are dispersed<br>uniformly<br>throughout the<br>dental ceramic<br>material and in<br>powdered<br>ceramic<br>products. | The colorants<br>are dispersed<br>uniformly<br>throughout the<br>dental ceramic<br>material and in<br>powdered<br>ceramic<br>products. | Meet the requirements of<br>ISO 6872:2015 | Same | | Freedom of<br>extraneous<br>materials | Device shall be<br>free from<br>extraneous<br>materials | Device shall be<br>free from<br>extraneous<br>materials | Meet the requirements of<br>ISO 6872:2015 | Same | | Radioactivity<br>of dental<br>ceramic | < 1.0Bq·g-1 of<br>238U | < 1.0Bq·g-1 of<br>238U | Meet the requirements of<br>ISO 6872:2015 | Same | | Flexural<br>Strength | >300MPa | >300MPa | Meet the requirements of<br>ISO 6872:2015 | Similar Note 4 | | Linear thermal<br>expansion<br>coefficient | (10±1.5)×10-6K-1 | (10±1.5)×10-6K-1 | Meet the requirements of<br>ISO 6872:2015 | Similar Note 5 | | Glass<br>transition<br>temperature | 550±50 °C | 550±50 °C | Meet the requirements of<br>ISO 6872:2015 | Similar Note 6 | | Chemical<br>solubility | <100µg/cm² | <100µg/cm² | Meet the requirements of<br>ISO 6872:2015 | Similar Note 7 | | | | | | | | Density | Ceramic block<br>density: 2.4 ~<br>2.6 g/cm³ | Ceramic block<br>Density: 2.3 ~<br>2.6 g/cm³<br>Density of<br>porcelain block<br>after sintering:<br>2.4 ~ 2.7 g/cm³ | Meet the requirements of<br>ISO 6872:2015 | Similar Note 8 | | In Vitro<br>Cytotoxicity<br>Test (ISO<br>10993-<br>5:2009) | No Cytotoxicity effect | No Cytotoxicity effect | No Cytotoxicity effect | Same | | Irritation Oral<br>Mucosa<br>Irritation (ISO<br>10993-<br>10:2010) | Not a primary oral mucosa irritant<br>under the conditions of the study | Not a primary oral mucosa irritant<br>under the conditions of the study | Not a primary oral mucosa<br>irritant under the conditions<br>of the study | Same | | Skin<br>Sensitization<br>(ISO 10993-<br>10:2010) | Not a sensitizer under the<br>conditions of the study | Not a sensitizer under the<br>conditions of the study | Not a sensitizer under the<br>conditions of the study | Same | | Subacute and<br>Subchronic<br>Toxicity (ISO<br>10993-<br>11:2017) | No subacute and subchronic<br>toxic effects observed | No subacute and<br>subchronic<br>toxic effects observed | No subacute and<br>subchronic<br>toxic effects observed | Same | | Genotoxicity<br>(ISO10993-<br>3:2014) | No genotoxic effects observed | No genotoxic effects<br>observed | No genotoxic effects<br>observed | Same | | Acute<br>Systemic<br>Toxicity (ISO<br>10993-<br>11:2017) | No acute Systemic Toxicity | / | / | Different Note<br>1 | | Pyrogen (ISO<br>10993-<br>11:2017) | Meets the requirements for the<br>absence of pyrogens | / | / | Different Note<br>2 | {6}------------------------------------------------ Image /page/6/Picture/0 description: The image contains a logo and Chinese text. The logo is an abstract orange shape, possibly representing a stylized letter or symbol. To the right of the logo, there are four Chinese characters, also in orange, which appear to be the name of a company or organization. The text is crisp and clear, suggesting a professional design. # Traditional 510(k) Submission of Soreal Press & Soreal CAD {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows a logo with an abstract orange shape on the left and the text "云甲科技" on the right. The abstract shape is composed of several lines that form a geometric pattern. The text is in Chinese characters and appears to be the name of a company or organization. #### Traditional 510(k) Submission of Soreal Press & Soreal CAD Tips: "/" means that it cannot be applicable. Similar Note 1: Although their Indications for Use is not same, they all meet the requirement of ISO 6872. So, this difference will not increase risk and affect the effectiveness and safety of the device. Similar Note 2: Although their composition may be slightly different, their main composition is SiO2, Li2O and K2O, and both meet the requirements of ISO 6872:2015. Their chemical and physical properties are basically the same and will not affect the safety and effectiveness of the device. {8}------------------------------------------------ Image /page/8/Picture/1 description: The image shows the logo for YunJia Technology. The logo consists of an orange abstract shape on the left, followed by the company name in Chinese characters on the right. The characters are also orange and appear to be slightly blurred. Similar Note 3: Since the shape of the equipment can be customized in subsequent processing, the shape will not affect the safety and effectiveness of the device. Similar Note 4: The Flexural Strength of devices is similar. But both products meet the requirements of ISO 6872:2015. The standard requires that the Flexural Strength should be higher than 300MPa. The data gap does not affect the actual safety and effectiveness of the product. This similarity does not affect the substantial equivalence of the product. Similar Note 5: According to ISO 6872:2015, the linear thermal expansion coefficient of the ceramics shall not deviate by more than 0.5 × 10-6 K-1 from the value stated by the manufacturer. The linear thermal expansion coefficient of ceramics specified by us is (10±1.5)×10ºK-1, and the test results of ISO 6872 show that the deviation does not exceed 0.5 × 10-6 K-1. The linear thermal expansion coefficient declared by the predicate product also meets the requirements of ISO 6872:2015. So, the differences will not affect performance and safety of devices. This similarity does not affect the substantial equivalence of the product. Similar Note 6: We cannot get the glass transition temperature of predicate device, so our device may be different from predicate device on glass transition temperature. According to ISO 6872:2015, the glass transition temperature of the ceramics shall not deviate by more than 20 ℃ from the value stated by the manufacturer. The glass transition temperature of ceramics specified by us is 550±50 °C, and the test results of ISO 6872 show that the deviation does not exceed 20 °C. The glass transition temperature declared by the predicate product also meets the requirements of ISO 6872:2015. So, the differences will not affect performance and safety of devices. This similarity does not affect the substantial equivalence of the product. Similar Note 7: The Chemical solubility of devices is similar. But both products meet the requirements of ISO 6872:2015. The standard requires that the Chemical solubility should be less than 100 uq/cm². The data qap does not affect the actual safety and effectiveness of the product. This similarity does not affect the substantial equivalence of the product. Similar Note 8: According to 6872:2015, the density is not necessary. We test the density. And the different density will not affect performance and safety of devices. This similarity does not affect the substantial equivalence of the product. Different Note 1: Predicate Device did not test the Acute Systemic Toxicity. But we test the Acute Systemic Toxicity. The difference will not affect performance and safety of devices. Different Note 2: Predicate Device did not test the Pyrogen. But we test the Pyrogen. The difference will not affect performance and safety of devices. All the differences don't affect the safety and effectiveness which is concluded after all the required testing, so no safety and effectiveness issues relating to the system come into conclusion. {9}------------------------------------------------ Image /page/9/Picture/1 description: The image shows the logo for YunJia Technology. The logo consists of an abstract geometric shape on the left, followed by the company name in Chinese characters on the right. The logo and text are both in orange color. # 7. Performance Data ## Clinical test: Clinical testing is not required. #### Non-clinical data The Performance tests were performed according to ISO 6872:2015 Dentistry - Ceramic materials, and the test results showed that the proposed device meets the requirements specified in the standard (see the following Table) | Test Item | Requirements | Measured data | Conclusion | | |--------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|-----------------------|------| | Uniformity | The colorants are<br>dispersed uniformly<br>throughout the dental<br>ceramic material and in<br>powdered ceramic<br>products. | The colorants are dispersed<br>uniformly throughout the<br>dental ceramic material and in<br>powdered ceramic products. | Pass | | | Freedom of<br>extraneous<br>materials | Device shall be free<br>from extraneous<br>materials | Device shall be free from<br>extraneous materials | Pass | | | Linear thermal<br>expansion<br>coefficient | $(10±1.5)×10^{-6}K^{-1}$ | $11.1×10^{-6}K^{-1}$ | Pass | | | Glass transition<br>temperature | 550±50 °C | Soreal CAD: 518.4°C<br>Soreal Press: 515.8°C | Pass | | | Chemical solubility | <100µg/cm² | Soreal CAD<br>(µg/cm²) | Pass | | | | | 22.37 | | | | | | 21.56 | | | | | | 22.38 | | | | | | 19.98 | | | | | | 23.20 | | | | | | 19.37 | | | | | | 20.68 | | | | | | 23.45 | | | | | | 21.76 | | | | | | Soreal Press<br>(µg/cm²) | | | | | | 21.87 | | | | | | 22.56 | | | | | | 21.33 | | | | | | 19.32 | | | | | | 21.21 | | | | | | 19.34 | | | | | | 19.63 | | | | | | 22.41 | | | | | | 24.12 | | | | | | 22.24 | 21.28 | | | Radioactivity of<br>dental ceramic | < 1.0Bq·g⁻¹ of ²³⁸U | <0.0073 Bq·g⁻¹ of ²³⁸U | | Pass | | Flexural Strength | >300MPa | Soreal CAD<br>(MPa) | Soreal Press<br>(MPa) | Pass | | | | 389 | 410 | | | | | 367 | 398 | | | | | 388 | 386 | | | | | 365 | 405 | | | | | 378 | 421 | | | | | 386 | 436 | | | | | 377 | 397 | | | | | 398 | 392 | | | | | 423 | 427 | | | | | 385 | 379 | | {10}------------------------------------------------ Image /page/10/Picture/0 description: The image shows a logo with an abstract orange design on the left and Chinese characters on the right. The design on the left appears to be a stylized geometric shape. The Chinese characters on the right are arranged horizontally and are also in orange. The logo is simple and modern, with a focus on the design and the Chinese characters. #### Traditional 510(k) Submission of Soreal Press & Soreal CAD Biocompatibility testing was performed to verify the equivalent safety of the materials that are used. The Biocompatibility tests were performed according to ISO 10933 Biocompatibility, and the test results showed that the proposed device meets the requirements specified in the standard (see the following Table) | Test Item | Requirements | Measured data | Conclusion | |-----------------------------------------------------------------|----------------------------------------------------------------------------|----------------------------------------------------------------------------|------------| | In Vitro<br>Cytotoxicity Test<br>(ISO 10993-<br>5:2009) | No Cytotoxicity effect | No Cytotoxicity effect | Pass | | Irritation Oral<br>Mucosa Irritation<br>(ISO 10993-<br>10:2010) | Not a primary oral mucosa<br>irritant under the<br>conditions of the study | Not a primary oral mucosa<br>irritant under the conditions<br>of the study | Pass | | Skin Sensitization<br>(ISO 10993-<br>10:2010) | Not a sensitizer under the<br>conditions of the study | Not a sensitizer under the<br>conditions of the study | Pass | {11}------------------------------------------------ Image /page/11/Picture/1 description: The image shows the logo for YunJia Technology. The logo consists of an orange abstract shape on the left, followed by the company name in Chinese characters on the right. The overall design is simple and modern, with a focus on the company's name and brand identity. | Subacute and<br>Subchronic<br>Toxicity (ISO<br>10993-11:2017) | No subacute and<br>subchronic toxic effects<br>observed | No subacute and<br>subchronic toxic effects<br>observed | Pass | |---------------------------------------------------------------|----------------------------------------------------------|---------------------------------------------------------|------| | Genotoxicity<br>(ISO10993-<br>3:2014) | No genotoxic effects<br>observed | No genotoxic effects<br>observed | Pass | | Acute Systemic<br>Toxicity (ISO<br>10993-11:2017) | No acute Systemic<br>Toxicity | No acute Systemic Toxicity | Pass | | Pyrogen (ISO<br>10993-11:2017) | Meets the requirements<br>for the absence of<br>pyrogens | Meets the requirements for<br>the absence of pyrogens | Pass | ## 8. Conclusion Information included in this premarket notification supports the substantial equivalence of the proposed Soreal Press/Soreal CAD. The proposed device has the identical intended use, identical indication for us, identical performance, identical fundamental technology, and identical biocompatibility as the predicate device K192231. The results of the testing support a determination of substantial equivalence.