Topzir 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 through dental laboratories or by dental professionals.

Device Description

Topzir 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.

Topzir Dental Zirconia Pre-Shaded 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 provided document describes the FDA's 510(k) clearance for the Topzir Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank. This is a material for dental restorations, not an AI/ML powered medical device. Therefore, many of the requested fields related to AI/ML device studies (such as sample size for test/training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance) are not applicable to this submission.

The acceptance criteria and device performance are primarily evaluated through non-clinical bench testing and biocompatibility testing against established international standards.

Here's a summary based on the provided text, indicating where information is not applicable (N/A) for a material device:

Acceptance Criteria and Reported Device Performance (Non-Clinical Bench Testing & Biocompatibility)

The device's performance was evaluated against ISO 6872:2015 (Dentistry - Ceramic materials) and ISO 10993:2018 (Biological evaluation of medical devices) series and ISO 7405:2018 (Dentistry - Evaluation of biocompatibility of medical devices used in dentistry).

Table of Acceptance Criteria and Reported Device Performance

Test Category	Specific Test Parameter	Acceptance Criteria (Standard)	Reported Device Performance (Result)
Physical/Mechanical	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	Cytotoxicity (ISO 10993-5:2009)	Non-cytotoxic	Pass (Non-cytotoxic)
	Oral Mucosa Irritation (ISO 10993-23:2021)	No potential irritation	Pass (No potential oral mucosa irritation)
	Skin Sensitization (ISO 10993-10:2021)	No delayed dermal sensitization	Pass (No evidence of causing delayed dermal contact sensitization)
	Subacute Toxicity (ISO 10993-11:2017)	No subacute systemic toxicity	Pass (Did not induce subacute systemic toxicity)
	Acute Systemic Toxicity (ISO 10993-11:2017)	No acute systemic toxicity	Pass (No evidence of causing acute systemic toxicity)
	In Vitro Mammalian Cell Gene Mutation (ISO 10993-3:2014)	Non-mutagenic	Pass (Considered non-mutagenic)
	In vitro Mammalian Chromosome Aberration (ISO 10993-3:2014)	No structural chromosome aberrations	Pass (Did not induce structural chromosome aberrations)
	Bacterial Reverse Mutation (ISO 10993-3:2014)	No potential mutagenesis	Pass (No potential mutagenesis)
	Muscle Implant (ISO 10993-6:2016)	No local effects	Pass (Did not induce local effects after implantation)

Study Details (as applicable for a material device):

Sample Size used for the test set and the data provenance:
- Test Set Sample Size: The document does not specify the exact sample sizes (number of blanks/specimens) used for each physical/mechanical bench test. For biocompatibility, animal models were used (e.g., L-929 cells for cytotoxicity, Syrian hamsters for oral mucosa irritation, guinea pig for skin sensitization, rats for subacute toxicity, ICR mice for acute systemic toxicity, CHL cells for gene mutation, and rabbits for muscle implant).
- Data Provenance: The document does not explicitly state the country of origin for the testing itself, but the manufacturer is based in Guangzhou, China. The testing appears to be conducted in a laboratory setting per international standards (ISO). The testing is prospective for the purpose of demonstrating substantial equivalence.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- N/A. This is a material device. Ground truth is established by adherence to standardized testing protocols and objective measurements according to ISO standards, performed by qualified laboratory personnel, rather than expert consensus on diagnostic images or clinical outcomes.
Adjudication method for the test set:
- N/A. As above, the evaluation is based on objective measurements against ISO standards, not subjective interpretation requiring adjudication.
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:
- N/A. This is not an AI/ML device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- N/A. This is not an AI/ML device.
The type of ground truth used:
- For physical/mechanical tests: Objective measurements against the specifications outlined in ISO 6872:2015.
- For biocompatibility tests: Laboratory results from in vitro and in vivo studies, evaluated against the criteria of the respective ISO 10993 and ISO 7405 standards.
The sample size for the training set:
- N/A. This is not an AI/ML device; there is no "training set" in this context. The manufacturing process of the material is established and validated, but not "trained" in the AI sense.
How the ground truth for the training set was established:
- N/A. As above, there is no training set. The quality control and manufacturing parameters for the material production are established through standard chemical engineering and materials science principles, aiming to consistently produce a material that meets the performance and biocompatibility specifications.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

March 31, 2023

Topzir Biotech Co., Ltd % Shanfeng Jiang 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: K230003

Trade/Device Name: Topzir 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: January 3, 2023 Received: January 3, 2023

Dear Shanfeng Jiang:

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 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 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

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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 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-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 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@fda.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 Quality Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K230003

Device Name

Topzir Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank

Indications for Use (Describe)

_ Over-The-Counter Use (21 CFR 801 Subpart C) × Prescription Use (Part 21 CFR 801 Subpart D) CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW. The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff

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PRAStaff@fda.hhs.gov

Type of Use (Select one or both, as applicable)

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Section 5 - 510(k) Summary

K230003

Date of Summary Preparation: March 14, 2023

1. Submitter's Identifications

Submitter's Name: Topzir Biotech Co., Ltd Address: Room 203, Creative Center, No.69, Guangpu West Road, Huangpu District, Guangzhou, Guangdong, China Zip Code: 510663 Contact Person: Hui Liu Contact Title: General Manager Contact E-mail Address: saleo1@topzir.com Tel: +86-020-32037865

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 Trade Name: Topzir Dental Zirconia Blank &Dental Zirconia Pre-Shaded Blank Model: HT-plus, ST, ST-C, ST-ML, ST PLUS, ST PLUS-C, ST PLUS-ML, 3D-pro-ML, TT, TT-C, TT-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 (Primary Predicate) Liaoning Upcera Company Limited

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5. Device Description

6. Intended Use of Device

Topzir 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 through dental laboratories or by dental professionals.

7. Summary of Substantial Equivalence

	Proposed Device	Predicate device	Comparison
510k Number	K230003	K141724	------
Product Code	EIH	EIH	Same
Proprietary Name	TopzirDentalZirconia Blank &Dental ZirconiaPre-Shaded Blank	UpceraDentalZirconia Blank &Dental ZirconiaPre-Shaded Blank	------
Model:	HT-plus, ST, ST-C,ST-ML, ST PLUS,ST PLUS-C, STPLUS-ML,3D-pro-ML, TT,TT-C, TT-ML	------	------
Manufacturer	Topzir Biotech Co.,Ltd	Liaoning UpceraCompany Limited	------

Indications forUse	Topzir DentalZirconia Blank &Dental ZirconiaPre-Shaded Blankare used for dentalrestorations usingdifferentCAD/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: >1450°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

Table 1 Comparison to Predicate Device

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Topzir Biotech 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+ 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 Topzir 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 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

Table 2 Biocompatibility testing
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Topzir Biotech Co., Ltd

Acute SystemicToxicity(ISO 10993-11:2017)	The test article showed no evidence of causingacute system toxicity in the ICR mice.	Pass
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
Bacterial ReverseMutation 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 implantationofbiomaterials in rabbits under this condition.	Pass

Note: Testing were Performed on Dental Zirconia Blank ST PLUS 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 Topzir Dental 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. Topzir 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.