Kingcera Dental Zirconia Blank

K241602 · Hunan Qinghao Puzhong Technology Co., Ltd. · EIH · Aug 30, 2024 · Dental

Device Facts

• Record ID: K241602
• Device Name: Kingcera Dental Zirconia Blank
• Applicant: Hunan Qinghao Puzhong Technology Co., Ltd.
• Product Code: EIH · Dental
• Decision Date: Aug 30, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6660
• Device Class: Class 2

Intended Use

Kingcera Dental Zirconia Blanks are used for dental restorations using different CAD/CAM or manual milling machines. All blanks are processed through dental laboratories or by dental professionals.

Device Story

Kingcera Dental Zirconia Blanks are ceramic dental materials composed of ZrO2, HfO2, Y2O3, and other oxides. Supplied as blocks, discs, or rods in various colors and translucencies. Used by dental professionals or laboratories to fabricate all-ceramic restorations (crowns, bridges, veneers, inlays/onlays) via CAD/CAM or manual milling machines. The device serves as a raw material for prosthetic fabrication; it does not perform automated analysis or computation. Benefits include the creation of patient-specific dental prosthetics.

Clinical Evidence

No clinical data. Bench testing only. Performance verified against ISO 6872:2015 (Dentistry - Ceramic materials) and ISO 10993-1 (Biocompatibility).

Technological Characteristics

Ceramic dental blanks composed of ZrO2, HfO2, Y2O3, and Fe2O3. Conforms to ISO 6872-2015. Form factors include blocks, discs, and rods. Processed via CAD/CAM or manual milling. Biocompatible per ISO 10993-1.

Indications for Use

Indicated for dental restorations, including crowns, bridges, veneers, and inlay/onlay, processed by dental professionals or laboratories using CAD/CAM or manual milling machines.

Regulatory Classification

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.

Predicate Devices

• Upcera Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blan (K141724)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the symbol of the Department of Health & Human Services on the left and the FDA acronym with the full name of the agency on the right. The FDA part is in blue, with the acronym in a solid blue square and the words "U.S. FOOD & DRUG ADMINISTRATION" next to it.

August 30, 2024

Hunan Qinghao Puzhong Technology Co., Ltd. % Yao Xiao RA Specialist Beijing Xinranyicheng Medicine & Technology Co., Ltd. A-1109. Langqin International Building. No.168. Guang'anmen Outer Street, Xicheng District Beijing, Beijing 10053 China

Re: K241602

Trade/Device Name: Kingcera Dental Zirconia Blank Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder For Clinical Use Regulatory Class: Class II Product Code: EIH Dated: April 22, 2024 Received: June 4, 2024

Dear Yao Xiao:

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"

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(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.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

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 ([e-mail]) or phone [phone] or 301-796-7100).

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Sincerely,

Bobak Shirmohammadi -S

For Michael E. Adjodha, M.ChE., RAC, CQIA 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

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## Indications for Use

Submission Number (if known)

K241602

Device Name

## Kingcera Dental Zirconia Blank

Indications for Use (Describe)

Kingcera Dental Zirconia Blanks are used for dental restorations using different CAD/CAM or manual milling machines. All blanks are processed through 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)

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| | Prepared on: 2024-06-04 | |
|------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| | 510(k) Summary | |
| | K241602 | |
| | 21 CFR 807.92(a)(1) | |
| Contact Details | | |
| Applicant Name | Hunan Qinghao Puzhong Technology Co., Ltd. | |
| Applicant Address | 1-3F, Building 2.2-F, Xinma Power Innovation Park, No.899 Xianyue Ring Road, Majiahe Street, Tianyuan District, Zhuzhou City, Hunan Province, 412007, China Zhuzhou Hunan 412007 China | |
| Applicant Contact Telephone | 0731 28700818 | |
| Applicant Contact | Mr. Zhiquan Wang | |
| Applicant Contact Email | [e-mail] | |
| Correspondent Name | Beijing Xinranyicheng Medicine & Technology Co., Ltd. | |
| Correspondent Address | A-1109, Langqin International Building, No.168, Guang'anmen Outer Street, Xicheng District, Beijing, China Beijing Beijing 10053 China | |
| Correspondent Contact Telephone | [phone] | |
| Correspondent Contact | Ms. Yao Xiao | |
| Correspondent Contact Email | [e-mail] | |
| Device Name | 21 CFR 807.92(a)(2) | |
| Device Trade Name | Kingcera Dental Zirconia Blank (MT, ST, UT, ET,Standard, Universal, Esthetic) | |
| Common Name | Porcelain powder for clinical use | |
| Classification Name | Powder, Porcelain | |
| Regulation Number | 872.6660 | |
| Product Code(s) | EIH | |
| Legally Marketed Predicate Devices | 21 CFR 807.92(a)(3) | |
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code |
| K141724 | Upcera Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blan | EIH |
| Device Description Summary | 21 CFR 807.92(a)(4) | |

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Kingcera Dental Zirconia Blanks are derived from zirconia powder that has been processed through various molding and sintering techniques - into their final net shapes. These blanks are further fabricated into various all-ceramic restorations such as crowns, bridges, veneers, and inlay/onlay. The zirconia powder is composed of ZrO2, HfO2, Y2O3, and other oxides; the performance of the Kingcera Dental Zirconia Blanks conforms to ISO 6872-2015. Dentistry: Ceramic Materials. Kingcera Dental Zirconia Blanks are ceramic dental blanks designed to manufacture ceramic devices. The dental prosthetic devices are fabricated by CAD/CAM machining processes. All prosthetic devices are intended for single-use applications. At the dental lab, the blanks are held to t. Kingcera Dental Zirconia Blanks are supplied in different shapes, such as blocks, discs, rods, or customized shapes. They are provided in combinations of ninety-nine different colors and a gradual-changing translucency effect. The different constituents of color additives (such as Fe2O3); the different translucencies originate from a slight difference in the amount of Y203.

# Intended Use/Indications for Use

Kingcera Dental Zirconia Blanks are used for dental restorations using different CAD/CAM or manual milling machines. All blanks are processed through dental laboratories or by dental professionals.

# Indications for Use Comparison

Kingcera Dental Zirconia Blank has the same indications for use as the predicate device.

# Technological Comparison

The information provided in this subject device is the equivalence of indication for use, material, Flexural Strength, and Chemical Solubility with the predicate device (K141724).Both devices used the same technology for CAD. The performance data demonstrates the proposed device performs as safely and effectively as the predicate device according to ISO 6872. All of our Zirconia Blank are biocompatible according to ISO 10993-1. Therefore, the differences raise no new questions of safety and effectiveness.

#### Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)

Performance testing has been carried out to device meets the performance specifications for its intended use. The following tests were performed on the device.

· ISO 6872 Fourth edition 2015-06-01 [including AMENDMENT 1 2018-04] Dentistry - Ceramic materials

Not Applicable

No animal studies or clinical testing have been required for these devices.

# 21 CFR 807.92(a)(5)

# 21 CFR 807.92(a)(5)

21 CFR 807.92(a)(6)