Dental Zirconia Blank 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 Description

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.

Dental Zirconia Blank are derived from the same Zirconia powder as the regular 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.

AI/ML Overview

The retrieved document is a 510(k) summary for a dental device (Dental Zirconia Blank). It is a regulatory submission demonstrating substantial equivalence to a predicate device, not a study designed to prove the device meets specific performance acceptance criteria for an AI/software product. Therefore, much of the requested information (sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) is not applicable to this document.

However, the document does contain information about non-clinical testing and general acceptance of these tests based on existing standards.

Here's a breakdown of the relevant information from the document:

1. Table of acceptance criteria and the reported device performance:

The document states that "Bench testing was performed per ISO 6872:2015 and internal procedures to ensure that the Dental Zirconia Blank met its specifications. All tests were verified to meet acceptance criteria." While specific numerical acceptance criteria are not tabulated, the document explicitly states that the tests passed these criteria. The relevant tests and their reported performance are:

Acceptance Criteria (Implied by adherence to standards)	Reported Device Performance
Radioactivity (per ISO 6872:2015)	Met acceptance criteria
Flexural Strength (per ISO 6872:2015)	Met acceptance criteria
Chemical Solubility (per ISO 6872:2015)	Met acceptance criteria
Linear Thermal Expansion Coefficient (per ISO 6872:2015)	Met acceptance criteria
Freedom from Extraneous Materials (per ISO 6872:2015)	Met acceptance criteria
Uniformity (per ISO 6872:2015)	Met acceptance criteria
Shrinkage Factor (per ISO 6872:2015)	Met acceptance criteria
Pre-sintered Density (per ISO 6872:2015)	Met acceptance criteria
Sintered Density (per ISO 6872:2015)	Met acceptance criteria
Fracture Toughness (per ISO 6872:2015)	Met acceptance criteria
Biocompatibility Testing (per ISO 10993-1:2018 and ISO 7405:2018):
Cytotoxicity (ISO 10993-5:2009)	Pass (non cytotoxic)
Oral Mucosa Irritation (ISO 10993-23:2021)	Pass (no potential irritation)
Skin Sensitization (ISO 10993-10:2021)	Pass (no sensitization)
Subacute Toxicity (ISO 10993-11:2017)	Pass (did not induce subacute systemic toxicity)
Acute Systemic Toxicity (ISO 10993-11:2017)	Pass (no acute system toxicity)
In Vitro Mammalian Cell Gene Mutation (ISO 10993-3:2014)	Pass (non-mutagenic)
In vitro Mammalian Chromosome Aberration (ISO 10993-3:2014)	Pass (did not induce structural chromosome aberrations)
Bacterial Reverse Mutation (ISO 10993-3:2014)	Pass (no potential mutagenesis)
Muscle Implant (ISO 10993-6:2016)	Pass (did not induce local effects)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document primarily discusses non-clinical bench testing and in vitro and in vivo biocompatibility tests, not a "test set" in the context of an AI/software solution. Therefore, information about a test set sample size or data provenance in that sense is not provided. The biocompatibility tests, however, would have involved animal models (Syrian hamsters, guinea pigs, rats, ICR mice, rabbits), which would constitute the "test set" for those specific biological evaluations. The document does not specify the number of animals used for each test. The testing was conducted by or on behalf of HUNAN CERAMASTER MATERIAL TECHNOLOGY CO.,LTD, located in China. The "provenance" of the data is therefore China. The nature of these tests is prospective for the specific evaluations conducted.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This is a material science and biocompatibility assessment for a dental zirconia blank, not an AI/software device requiring expert interpretation for ground truth establishment.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This type of adjudication is typically used for human-reviewed data in AI/software evaluations.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This document pertains to a physical dental material, not an AI-assisted diagnostic or therapeutic device.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This is not an algorithm or software device. Bench testing and biocompatibility studies evaluate the material's properties directly.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the non-clinical tests is established by recognized international standards (ISO 6872:2015 for material properties, ISO 10993 series and ISO 7405:2018 for biocompatibility). The acceptance criteria outlined in these standards serve as the "ground truth" to determine if the device meets its specifications. For biocompatibility tests, the outcomes observed in the biological test systems (e.g., cell viability, tissue response, animal health) against the defined parameters of the ISO standards constitute the "ground truth."

8. The sample size for the training set

Not applicable. There is no AI algorithm or "training set" involved in the testing described for this dental material.

9. How the ground truth for the training set was established

Not applicable. Since there is no training set, this question is not relevant.

Summary

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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 features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.

May 20, 2024

Hunan Ceramaster Material Technology Co., Ltd Bin Wang General Manager 103, Building B4, Dreamworks, No.1 Lantian North Road, Xingsha Industrial Base Changsha, Hunanng 410137 CHINA

Re: K240772

Trade/Device Name: Dental Zirconia Blank (HT-plus, ST-C, ST-ML, SHT-C, SHT-ML, UT-C, UT-ML, Pro- ML) Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder For Clinical Use Regulatory Class: Class II Product Code: EIH Dated: March 21, 2024 Received: March 21, 2024

Dear Bin Wang:

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.

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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" (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 QS 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).

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Sincerely,

Michael E. Adjodha -S

Michael E. Adjodha, MChE, 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

510(k) Number (if known) K240772

Device Name

Dental Zirconia Blank (HT-plus, ST-C, ST-ML, SHT-C, SHT-ML, UT-C, UT-ML, Pro- ML)

Indications for Use (Describe)

Dental Zirconia Blank 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)Over-The-Counter Use (21 CFR 801 Subpart C) X Prescription Use (Part 21 CFR 801 Subpart D)
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K240772

HUNAN CERAMASTER MATERIAL TECHNOLOGY CO.,LTD

Section 4 - 510(k) Summary

Date of Summary Preparation: May 09, 2024

1. Submitter's Identifications

Submitter's Name: HUNAN CERAMASTER MATERIAL TECHNOLOGY CO.,LTD Address: 103, Building B4, Dreamworks, No.1 Lantian North Road, Xingsha Industrial Base, Changsha ,Hunan CHINA Zip Code: 410137 Contact Person: Bin Wang Contact Title: General Manager Contact E-mail Address: eckes2(@gg.com Tel: +86-731-88218650

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: Shanfeng Jiang Contact Title: Regulation Control Manager Contact E-mail Address: jiang13620586569@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 Common Name: Dental Zirconia Ceramics Trade Name: Dental Zirconia Blank (HT-plus, ST-C, ST-ML, SHT-C, SHT-ML, UT-C, UT-ML, Pro- 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

Predicate device: K141724 Upcera Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank Liaoning Upcera Company Limited

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5. Device Description

6. Indications for Use

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

7. Summary of Substantial Equivalence

	Proposed Device	Predicate device	Comparison
510k Number	K240772	K141724	------
Product Code	EIH	EIH	Same
Proprietary Name	Dental ZirconiaBlank (HT-plus,ST-C, ST-ML,SHT-C, SHT-ML,UT-C, UT-ML,Pro- ML)	Upcera DentalZirconia Blank &Dental ZirconiaPre-Shaded Blank	------
Model:	HT-plus, ST-C,ST-ML, SHT-C,SHT-ML, UT-C,UT-ML, Pro- ML	------	------
Manufacturer	HUNANCERAMASTERMATERIALTECHNOLOGY	Liaoning UpceraCompany Limited	------
	CO.,LTD
Indications forUse	Dental ZirconiaBlank are used fordental restorationsusing differentCAD/CAM ormanual millingmachines. Allblanks areprocessed throughdental laboratoriesor by dentalprofessionals.	Upcera DentalZirconia Blank &Dental ZirconiaPre-Shaded Blankare used for dentalrestorations usingdifferentCAD/CAM ormanual millingmachines. Allblanks areprocessed thoughdental laboratoriesor by dentalprofessionals.	Same
Basic design	Blocks, and rods	Blocks, disc, androd	Same
Materials	Regular:Zirconia (ZrO2+Y2O3+ HfO2+Al2O3≥99.0%)Pre-shaded:Zirconia (ZrO2+Y2O3+ HfO2+Al2O3≥99.0%)Inorganic pigments(Fe2O3, Er2O3 andMnO <2.0%)	Regular:Zirconia (ZrO2+Y2O3+ HfO2+Al2O3≥99.0%)Pre-Shaded:Zirconia (ZrO2+Y2O3+ HfO2+Al2O3≥98.0%)Inorganic pigments(Fe2O3, Pr2O3, andEr2O3 <2.0%)	Similar¹
Processing	Sintering attemperature: >1480 °C	Sintering attemperature: >1500 °C	Similar²
Dimension	Various	Various	Same
Single Use	Yes	Yes	Same
Color	None, andPre-shaded (forpre-shaded series)	None, andPre-shaded (forpre-shaded series)	Same
Sterile	Non-sterile	Non-sterile	Same

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The proposed device is essentially identical to the predicate devices in terms of

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indication for use, design between our device and the predicate devices. The minor differences are that as below:

Note 1: Zirconia (ZrO2+ Y2O3+ 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, Pr2O3, 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 Dental Zirconia 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 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(ISO 10993-5:2009)	Under the conditions of this study, the test articlewas non cytotoxic for 2 h and 24 h in the filterdiffusion method.Under the conditions of this study, the test articlewas accepted in the agar diffusion method.Under the conditions of this study, the test articlehas no potential toxicity to L-929 cells.	Pass
Oral Mucosa Irritation(ISO 10993-23:2021)	The test article has no potential oral mucosairritation in the Syrian hamsters.	Pass
Skin SensitizationTest(ISO 10993-10:2021)	The test article showed no evidence of causingdelayed dermal contact sensitization in the guineapig.	Pass
Subacute ToxicityTest(ISO 10993-11:2017)	The test result showed that the test article did notinduce subacute systemic toxicity in rats underthis condition .	Pass
Subacute SystemicToxicity Test(ISO 10993-11:2017)	The test result showed that the test article did notinduce subacute systemic toxicity in rats underthis condition.	Pass
Acute Systemic	The test article showed no evidence of causing	Pass

	Table 2 Biocompatibility testing

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HUNAN CERAMASTER MATERIAL TECHNOLOGY CO.,LTD

Toxicity(ISO 10993-11:2017)	acute system toxicity in the ICR mice.
In Vitro MammalianCell Gene MutationTest(ISO 10993-3:2014)	Under the conditions of this study, the test articleis considered non-mutagenic.	Pass
In vitro MammalianChromosomeAberration Test(ISO 10993-3:2014)	Under the conditions of this study, the test articledid not induce structural chromosome aberrationsin cultured CHL cells.	Pass
BacterialReverseMutation Test(ISO 10993-3:2014)	Under the conditions of this study, the number ofreverting colonies in the test article group is notequal to or greater than 2 times that of thespontaneous control, so the test article have nopotential mutagenesis.	Pass
Muscle Implant(ISO 10993-6:2016)	The test result showed that the test article did notinduce local effects after implantation ofbiomaterials in rabbits under this condition.	Pass

Note: Testing were Performed on Dental Zirconia Blank ST-C with Pre-Shaded powder C4 (C4 is deep color, see the VITA 16 color shade guide picture) 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 Dental Zirconia Blank performs as well as or better than the legally marketed predicate device K141724 Upcera Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank. Dental Zirconia Blank is substantial equivalent to the legally marketed predicate device K141724 Upcera Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank.

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.