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.

AI/ML Overview

The provided document is a 510(k) Premarket Notification from the FDA for a Zirconia Block used in dental restorations. This document does not describe an AI medical device or a study proving its performance against acceptance criteria.

Therefore, I cannot extract the information required to answer your questions about acceptance criteria and a study proving a device meets them. The document pertains to a dental material, not an AI or software-based medical device.

Summary

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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"

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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.

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 ZoneInnovation Park II, China
Tel:	086 0731 23228019
Contact person and title:	Chen fusheng, Head of Firm
E-mail	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
E-mail	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

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
TechnologicalCharacteristics	Subject deviceZirconia Block	Aidite (Qinhuangdao) Technology Co., Ltd.Dental Zirconia CeramicK222626
Product code	EIH	EIH
Indications for Use	HT, HT-C, ST, ST-C, ST-ML, SHT,SHT-C, SHT-ML: used to make thecrown, bridge, inlay, veneer of theall-porcelain restoration.UT, UT-C, UT-ML and 3D-PRO: used tomake the crown, maximum 3-unit bridge,inlay, veneer of the all-porcelainrestoration.	Dental Zirconia Ceramic are used for dentalrestorations using different CAD/CAM ormanual milling machines. All blanks areprocessed through dental laboratories or bydental professionals.
Composition	ZrO2, Y2O3, Al2O3 and other oxides	ZrO2, Y2O3, Al2O3 and other oxides
Pressing at Dentallab	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 physicalproperty as they all conform to the specifications set by internal final inspection and thetest 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.

Regulation Number and Section

§ 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.