Zirdent Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank are used for dental restorations using different CAD/ CAM or manual milling machines. All blanks are processed thought dental laboratories or by dental professionals.

Device Description

Zirdent 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.

Zirdent Dental Zirconia Pre-Shaded Blank are derived from the same Zirconia powder as the regular Zirdent 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

This appears to be an FDA 510(k) Premarket Notification summary for a dental device, "Zirdent Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific "acceptance criteria" through a clinical efficacy study involving human readers or AI algorithms.

Therefore, many of the requested items regarding acceptance criteria, expert ground truth, adjudication, MRMC studies, standalone AI performance, and AI training/test sets are not applicable to this document. This document describes a material equivalence study, not an AI or diagnostic efficacy study.

However, I can extract the relevant information regarding the performance testing that was conducted.

Here's an interpretation based on the provided text:

Device: Zirdent Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank

This device is a dental material (zirconia blanks) used for dental restorations. The "acceptance criteria" in this context refer to the physical and chemical properties of the material and its biocompatibility, as measured against international standards and comparison to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

The "acceptance criteria" for this material are defined by adherence to international standards and demonstration of equivalent performance to a predicate device.

Acceptance Criterion (Standard/Test)	Reported Device Performance (Zirdent Dental Zirconia Blank)	Conclusion
Material Composition	Conforms to ISO 13356: Implants for surgery - Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP)	Pass
- Zirconia (ZrO2+ Y2O3+ HfO2+ Al2O3) content	≥ 99.0%	Pass (Higher than predicate ≥ 98.0%)
- Inorganic Pigments (for Pre-Shaded)	Fe2O3, Er2O3, and MnO < 2.0%	Pass (Similar to predicate)
Physical Performance	Conforms to ISO 6872: Dentistry - Ceramic materials	Pass
- Radioactivity	Very similar to predicate device	Pass
- Flexural Strength	Very similar to predicate device	Pass
- Chemical Solubility	Very similar to predicate device	Pass
- Linear Thermal Expansion Coefficient	Very similar to predicate device	Pass
- Freedom from extraneous materials	Very similar to predicate device	Pass
- Uniformity	Very similar to predicate device	Pass
- Shrinkage Factor	Very similar to predicate device	Pass
- Pre-sintered Density	Very similar to predicate device	Pass
- Sintered Density	Very similar to predicate device	Pass
- Fracture Toughness	Very similar to predicate device	Pass
Biocompatibility (per ISO 10993-1:2018 and ISO 7405:2018)
- Cytotoxicity (ISO 10993-5:2009)	Non-cytotoxic (2h), Mildly cytotoxic (24h) in filter diffusion; Accepted in agar diffusion; No potential toxicity to L-929 cells.	Pass
- Oral Mucosa Irritation (ISO 10993-10:2010)	No evidence of causing oral mucosa irritation in Syrian hamsters.	Pass
- Delayed Dermal Contact Sensitization (ISO 10993-10:2010)	No evidence of causing delayed dermal contact sensitization in guinea pig.	Pass
- Subacute Toxicity (ISO 10993-11:2017)	No evidence of causing acute systemic toxicity in ICR mice.	Pass
- Subchronic Toxicity (ISO 10993-11:2017)	No subacute/subchronic systemic toxicity in rats (28/90 days).	Pass
- Mutagenesis (ISO 10993-3:2014)	Considered non-mutagenic; No potential mutagenesis (no significant increase in reverting colonies).	Pass
- Genotoxicity Toxicity (ISO 10993-3:2014)	No induced potential genotoxicity in ICR mice.	Pass
- Local Effects After Implantation (ISO 10993-6:2016)	No induced local effects after implantation in rabbits.	Pass
Processing (Sintering Temperature)	> 1450°C	Pass (Slightly lower than predicate > 1500°C, but performance passed)

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: The document does not specify the exact number of samples (e.g., number of zirconia blanks or specimens) used for each bench test (e.g., flexural strength, solubility). It generally states "Bench testing was performed per ISO 6872:2015 and internal procedures." For biocompatibility, it refers to standard animal models (e.g., Syrian hamsters, guinea pigs, ICR mice, rats, rabbits), implying sample sizes appropriate for those in-vivo tests according to the ISO standards.
Data Provenance: The study was conducted by Zirdent New Material Co., Ltd. located in Changsha, Hunan, China. The biocompatibility tests were conducted by a third-party lab, but the location of the lab and the specific origin of the test animals are not explicitly stated, beyond being "per ISO standards." The data is retrospective in the sense that it was collected prior to the 510(k) submission.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not Applicable. This is a material properties and biocompatibility study, not a study involving human expert interpretation of images or data to establish ground truth for a diagnostic AI. The "ground truth" here is defined by objective physical measurements and standardized biological responses.

4. Adjudication Method for the Test Set

Not Applicable. As per point 3, this is not a study requiring adjudication of expert opinions. The results are based on objective measurements and established biological assays.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. An MRMC study is relevant for diagnostic devices (e.g., AI for image interpretation) to compare human performance with and without AI assistance. This device is a dental material, not a diagnostic tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not Applicable. This device is not an algorithm.

7. The Type of Ground Truth Used

For Physical Performance: The ground truth is defined by the specifications and limits set by international standards (ISO 13356, ISO 6872) and comparison to the performance of a legally marketed predicate device (K141724 Upcera Dental Zirconia Blank).
For Biocompatibility: The ground truth is established by standardized biological assays (in vitro and in vivo) per ISO 10993 series and ISO 7405, where "Pass" indicates that the material meets the safety criteria (e.g., no significant toxicity, irritation, sensitization, etc.) defined by these standards.

8. The Sample Size for the Training Set

Not Applicable. This device is a physical material, not an AI model that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not Applicable. As per point 8.

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 is in blue and includes the letters "FDA" in a square and the words "U.S. FOOD & DRUG ADMINISTRATION".

November 12, 2021

Zirdent New Material Co., Ltd % Jinghua Zhou Regulation Control Manager Guangzhou Junyi Information Technology Co., Ltd. Room 304, Building A. No. 62 Nanyun 2nd Road, Science Town Huangpu District, Guangzhou City, Guangdong 510663 China

Re: K212259

Trade/Device Name: Zirdent Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder For Clinical Use Regulatory Class: Class II Product Code: EIH Dated: August 18, 2021 Received: August 18, 2021

Dear Jinghua Zhou:

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 mav, 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.

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

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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-reporting-

combination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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(@tda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Bobak Shirmohammadi -S

For 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 Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K212259

Device Name

Zirdent Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank

Indications for Use (Describe)

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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Section 5 - 510(k) Summary

K212259

Date of Summary Preparation: July 6, 2021 Date of Modification: August 13, 2021

1. Submitter's Identifications

Submitter's Name: Zirdent New Material Co., Ltd Address: No.101, 3rd building of Hai Ping International Medical Device Industrial Area, No.229, Guyuan Road, Hi-tech New District, Changsha, Hunan, China Zip Code: 410205 Contact Person: Jia Li Contact Title: General Manager Contact E-mail Address: 448658264@qq.com Tel: +86-731-85529297 Fax: +86-731-88995949

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: Jinghua Zhou Contact Title: Regulation Control Manager Contact E-mail Address: admanzhou@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 Trade Name: Zirdent Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank Model: HT-plus, ST, ST-C, ST-ML, SHT, SHT-C, SHT-ML, 3D-pro-ML, UT, UT-C, UT-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

Primary Predicate device: K141724 Upcera Dental Zirconia Blank & Dental Zirconia

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Pre-Shaded Blank Liaoning Upcera Company Limited

5. Device Description

6. Intended Use of Device

Zirdent Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank are used for dental restorations using different CAD/CAM or manual milling machines. All blanks are processed thought dental laboratories or by dental professionals.

	Proposed Device	Predicate device	Comparison
510k Number	K212259	K141724	-------
Product Code	EIH	EIH	Same
Proprietary Name	Zirdent DentalZirconia Blank &Dental ZirconiaPre-Shaded Blank	Upcera DentalZirconia Blank &Dental ZirconiaPre-Shaded Blank	-------
Model	HT-plus, ST, ST-C,ST-ML, SHT,SHT-C, SHT-ML,3D-pro-ML, UT,UT-C, UT-ML	-------	-------
Manufacturer	Zirdent NewMaterial Co., Ltd	Liaoning UpceraCompany Limited	-------
Indications forUse	Zirdent Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank are used for dental restorations using different CAD/CAM or manual milling machines. All blanks are processed thought dental laboratories or by dental professionals.	Upcera Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank are used for dental restorations using different CAD/CAM or manual milling machines. All blanks are processed thought dental laboratories or by dental professionals.	Same
Basic design	Blocks, and rods	Blocks, disc, and rod	Same
Materials	Regular:Zirconia (ZrO2+ Y2O3+ HfO2+ Al2O3≥99.0%)Pre-shaded:Zirconia (ZrO2+ Y2O3+ HfO2+ Al2O3≥99.0%)Inorganic pigments (Fe2O3, Er2O3 and MnO <2.0%)	Regular:Zirconia (ZrO2+ Y2O3+ HfO2+ Al2O3≥99.0%)Pre-Shaded:Zirconia (ZrO2+ Y2O3+ HfO2+ Al2O3≥98.0%)Inorganic pigments (Fe2O3, Pr2O3, and Er2O3 <2.0%)	Similar1
Processing	Sintering at temperature: > 1450°C	Sintering at temperature: > 1500°C	Similar2
Dimension	Various	Various	Same
Single Use	Yes	Yes	Same
Color	None, and Pre-shaded (for pre-shaded series)	None, and Pre-shaded (for pre-shaded series)	Same
Sterile	Non-sterile	Non-sterile	Same

7. Summary of Substantial Equivalence

Table 1 Comparison to Predicate Device

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Zirdent New Material Co., Ltd

The proposed device is essentially identical to the predicate devices in terms of indication for use, design between our device and the predicate devices. The minor

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differences are that as below:

Note 1: Zirconia (ZrO2+ Y2O2+ 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, ProO3, 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 Zirdent Dental Zirconia Blank & Dental Zirconia Pre-Shaded 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 ISO 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 article was non cytotoxic for 2 h and mildly cytotoxic for 24 h in the filter diffusion method.Under the conditions of this study, the test article was accepted in the agar diffusion method.Under the conditions of this study, the test article has no potential toxicity to L-929 cells.	Pass
Oral Mucosa Irritation(ISO 10993-10:2010)	The test article showed no evidence of causing oral mucosa irritation in the Syrian hamsters.	Pass
Delayed DermalContact Sensitization(ISO 10993-10:2010)	The test article showed no evidence of causing delayed dermal contact sensitization in the guinea pig.	Pass
Subacute Toxicity(ISO 10993-11:2017)	The test article showed no evidence of causing acute system toxicity in the ICR mice.	Pass
Subchronic Toxicity(ISO 10993-11:2017)	The test results showed that the test article did not induce subacute systemic toxicity 28 days in rats and 90 days in rats under these conditions.	Pass
Mutagenesis	Under the conditions of this study, the test article	Pass

Table 2 Biocompatibility testing

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Zirdent New Material Co., Ltd

(ISO 10993-3:2014)	is considered non-mutagenic.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.
Genotoxicity Toxicity(ISO 10993-3:2014)	The test result showed that the extract of the testarticle did not induce the potential genotoxicitytoxicity in ICR mice under this condition.	Pass
Local Effects AfterImplantation(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 pre-shaded zirconia blank (UT-C) 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 Zirconia Blank & Dental Zirconia Pre-Shaded Blank performs as well as or better than the legally marketed predicate device K141724 Upcera Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank. Zirdent Dental Zirconia Blank & Dental Zirconia Pre-Shaded 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.