(60 days)
No reference devices were used in this submission.
No
The description focuses on the material composition and manufacturing process (CAD/CAM, milling, sintering) of a dental restoration block. There is no mention of AI or ML being used in the design, manufacturing, or intended use of the device. The "ML" in some product names (ST-ML, UT-ML) likely refers to a material property or variant, not machine learning.
No
This device is a material (Zirconia Block) used to create dental restorations, not a therapeutic device that directly treats, cures, or mitigates a disease or condition in a patient.
No
Explanation: The device is a Zirconia Block used for making dental restorations such as crowns, bridges, inlays, and veneers. It is a material for manufacturing prosthetics, not a tool for diagnosing medical conditions.
No
The device is a physical material (Zirconia Block) used in the manufacturing of dental restorations. While it is used in conjunction with CAD/CAM technology, the device itself is not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to create dental restorations (crowns, bridges, etc.) for patients. This is a therapeutic and restorative purpose, not a diagnostic one.
- Device Description: The description details the process of using the zirconia block to fabricate dental prosthetics. This involves physical manipulation and processing of the material to create a device that is placed in the patient's mouth.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples from the human body (blood, urine, tissue, etc.) or to provide information for the diagnosis of a disease or condition.
- Anatomical Site: The anatomical site is the tooth, which is where the final restoration is placed, not where a diagnostic sample would typically be taken or analyzed.
IVD devices are specifically designed to perform tests on samples from the human body to provide information for diagnosis, monitoring, or screening. This device's function is to create a physical restoration for a patient's tooth.
N/A
Intended Use / Indications for Use
HT, HT-C, ST, ST-C, ST-ML, SHT, SHT-C, SHT-ML: used to make the crown, bridge, inlay, veneer of the all-porcelain restoration.
UT, UT-C, UT-ML and 3D-PRO: used to make the crown, maximum 3-unit bridge, inlay, veneer of the all-porcelain restoration.
Product codes
EIH
Device Description
Zirconia Block is used for dental restorations, such as crown, bridge, inlay, veneer, using CAD/CAM or manual milling machines. The main ingredients of the product include zirconia, yttrium oxide, hafnium oxide, alumina and other oxides. Through the digital scanning of the tooth or tooth mold, the three-dimensional data of the tooth mold is obtained. According to the CAD design is carried out to design the porcelain block processing model. Then CNC machine tool was used to make CAM according to the porcelain block processing model, and the inner crown of all-porcelain denture was made by air sintering or vacuum sintering, so as to achieve the strength and aesthetic effect required by clinical use. Finally, the inner crown of the all-porcelain denture was glazed with porcelain powder to form the combination of porcelain, and the all-porcelain denture was made.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Test standards and methods based on ISO 6872:2015 (Dentistry - Ceramic materials). And the results from testing demonstrate that Zirconia Block is substantially equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
No reference devices were used in this submission.
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.6660 Porcelain powder for clinical use.
(a)
Identification. Porcelain powder for clinical use is a device consisting of a mixture of kaolin, felspar, quartz, or other substances intended for use in the production of artificial teeth in fixed or removable dentures, of jacket crowns, facings, and veneers. The device is used in prosthetic dentistry by heating the powder mixture to a high temperature in an oven to produce a hard prosthesis with a glass-like finish.(b)
Classification. Class II.
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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 9, 2024
Hunan Hualian Special Ceramics Co., Ltd. % Jennifer Liu Regulatory Affairs Manager Chenhe Medical Consulting Co., Ltd Room 113, 7th Floor, Block B. Building 1 No. A 38, Zhongguancun Street, Haidian District Beijing. China
Re: K241316
Trade/Device Name: Zirconia Block Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain powder for clinical use Regulatory Class: Class II Product Code: EIH Dated: May 10, 2024 Received: May 10, 2024
Dear Jennifer Liu:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
Bobak Shirmohammadi -S
For Michael E. Adjodha, MChE, RAC, CQIA Assistant Director DHT1B: Division of Dental and ENT Devices
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OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K241316
Device Name Zirconia Block
Indications for Use (Describe)
HT, HT-C, ST, ST-C, ST-ML, SHT-C, SHT-ML: used to make the crown, bridge, inlay, veneer of the all-porcelain restoration.
UT, UT-C, UT-ML and 3D-PRO: used to make the crown, maximum 3-unit bridge, inlay, veneer of the all-porcelain restoration.
| 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) |
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510(k) Summary
510(k) Summary - K241316
This summary of 510(k) for the subjective device equivalence information is being submitted in accordance with the requirements of 21 C.F.R. 807.92.
1. Date Summary Prepared: May 6, 2024
2. Contact details
- 2.1 Applicant information:
| Name | Hunan Hualian Special Ceramics Co.,ltd |
|---|---|
| Address | Hunan Province Liling Economic Development Zone |
| Innovation Park II, China | |
| Tel: | 086 0731 23228019 |
| Contact person and title: | Chen fusheng, Head of Firm |
| 41859879@qq.com |
2.2 Submission Correspondent
| Name | Chenhe Medical Consulting Co., Ltd |
|---|---|
| Address | Room 113, 7th Floor, Block B, Building 1, No. A 38, |
| Zhongguancun Street, Haidian District, Beijing, China | |
| Tel: | 086 633 13774915658 |
| Contact person and title: | Jennifer Liu/Regulatory Affairs Manager |
| Jennifer19862022@163.com |
3. Device Name
Trade name: Zirconia Block
Classification name: Powder, Porcelain
Regulatory Class: II
Product Code: EIH
4. Predicate Device Information
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| Table 1: Predicate Device Information | |||||
|---|---|---|---|---|---|
| Owner/Operator | Device Trade Name | 510 (k) No. | Product Code | Predicate | |
| Aidite (Qinhuangdao) | |||||
| Technology Co., Ltd. | Dental Zirconia Ceramic | K222626 | EIH | Primary |
This predicate device has not been subject to a design-related recall.
No reference devices were used in this submission.
5. Description of Device
Zirconia Block is used for dental restorations, such as crown, bridge, inlay, veneer, using CAD/CAM or manual milling machines. The main ingredients of the product include zirconia, yttrium oxide, hafnium oxide, alumina and other oxides. Through the digital scanning of the tooth or tooth mold, the three-dimensional data of the tooth mold is obtained. According to the CAD design is carried out to design the porcelain block processing model. Then CNC machine tool was used to make CAM according to the porcelain block processing model, and the inner crown of all-porcelain denture was made by air sintering or vacuum sintering, so as to achieve the strength and aesthetic effect required by clinical use. Finally, the inner crown of the all-porcelain denture was glazed with porcelain powder to form the combination of porcelain, and the all-porcelain denture was made.
6. Indications for Use
HT, HT-C, ST, ST-C, ST-ML, SHT, SHT-C, SHT-ML: used to make the crown, bridge, inlay, veneer of the all-porcelain restoration.
UT, UT-C, UT-ML and 3D-PRO: used to make the crown, maximum 3-unit bridge, inlay, veneer of the all-porcelain restoration.
7. Summary of Physical and Chemical Properties Tests
Test standards and methods based on ISO 6872:2015 (Dentistry - Ceramic materials). And the results from testing demonstrate that Zirconia Block is substantially equivalent to the predicate device.
8. Technological Characteristics
All components of the subject device are based upon industry well-known chemistry. The following table shows the significant technological characteristics for the subject device and indicates the following similarities and differences with the predicate device:
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| Primary predicate | ||
|---|---|---|
| Technological | ||
| Characteristics | Subject device | |
| Zirconia Block | Aidite (Qinhuangdao) Technology Co., Ltd. | |
| Dental Zirconia Ceramic | ||
| K222626 | ||
| Product code | EIH | EIH |
| Indications for Use | HT, HT-C, ST, ST-C, ST-ML, SHT, | |
| SHT-C, SHT-ML: used to make the | ||
| crown, bridge, inlay, veneer of the | ||
| all-porcelain restoration. | ||
| UT, UT-C, UT-ML and 3D-PRO: used to | ||
| make the crown, maximum 3-unit bridge, | ||
| inlay, veneer of the all-porcelain | ||
| restoration. | Dental Zirconia Ceramic are used for dental | |
| restorations using different CAD/CAM or | ||
| manual milling machines. All blanks are | ||
| processed through dental laboratories or by | ||
| dental professionals. | ||
| Composition | ZrO2, Y2O3, Al2O3 and other oxides | ZrO2, Y2O3, Al2O3 and other oxides |
| Pressing at Dental | ||
| lab | Sintering Press | Sintering Press |
| CAD/CAM | CAD/CAM | |
| Dimension | Various | Various |
| Single use | Yes | Yes |
| Available Color | Various | Various |
| Sterile | Non-sterile | Non-sterile |
| Physical Properties | The subject device and the predicate device have substantially equivalent physical | |
| property as they all conform to the specifications set by internal final inspection and the | ||
| test method equal to ISO 6872:2015. |
9. Summary of Biocompatibility
The new device, Zirconia Blocks, is substantially equivalent to the predicate devices that have been legally marketed for decades and with no clinical adverse events. The formulation of new device does not contain any non-conventional chemicals compared to the legally marketed predicate device. Biocompatibility tests were performed fully following the ISO 10993 standards. The test items include Cytotoxicity, Sensitization, Irritation, Systemic Toxicity, Subchronic Toxicity and Genotoxicity.
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10. Clinical Performance Data
Not applicable. Clinical performance testing has not been performed for the subject device.
11. Conclusions
Based on the indications for use, technological characteristics, performance testing and comparison to predicate devices, the subject device has been shown to be safe and effective for its intended use and the minor differences in indications for use fall within the intended use of the predicate devices affecting neither the general intended use nor substantial equivalence. Hunan Hualian Special Ceramics Co.,ltd concludes that the subject device is substantially equivalent to the predicate devices described herein.