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

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 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

This document describes the premarket notification for the "Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank" device, which is a Class II device (Product Code: EIH). The submission aims to establish substantial equivalence to a predicate device (K141724 Upcera Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank).

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are primarily based on established international standards for ceramic dental materials and biocompatibility. The reported device performance indicates that the device meets these standards.

Acceptance Criterion (Standard)	Reported Device Performance and Acceptance
Material Composition
Zirconia composition conforms to ISO 13356 for Y-TZP.	Reported: Zirconia powder composed of ZrO2+ Y2O3+ HfO2+ Al2O3 with its composition conforms to ISO 13356. (Pass)
Regular Blanks: Zirconia (ZrO2+ Y2O3+ HfO2+ Al2O3) ≥ 99.0%	Reported: Regular Blanks: Zirconia (ZrO2+ Y2O3+ HfO2+ Al2O3) ≥ 99.0%. (Pass - stated as higher than predicate and passed biocompatibility and performance testing)
Pre-Shaded Blanks: Zirconia (ZrO2+ Y2O3+ HfO2+ Al2O3) ≥ 99.0%	Reported: Pre-shaded Blanks: Zirconia (ZrO2+ Y2O3+ HfO2+ Al2O3) ≥ 99.0%. (Pass - stated as higher than predicate and passed biocompatibility and performance testing)
Inorganic pigments for pre-shaded blanks < 2.0%	Reported: Inorganic pigments (Fe2O3, Er2O3 and MnO < 2.0%). (Pass - stated as minor difference and passed biocompatibility testing)
Device Performance (Conforms to ISO 6872)	Reported: The performance of the dental blanks conforms to ISO 6872, Dentistry - Ceramic materials. 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. (Pass)
Biocompatibility (Conforms to ISO 10993-1 and ISO 7405)	Reported:
Cytotoxicity (ISO 10993-5:2009)	Result: Non-cytotoxic for 2h and 24h (filter diffusion); None cytotoxic (agar diffusion); no potential toxicity to L-929 cells. (Pass)
Oral Mucosa Irritation (ISO 10993-10:2010)	Result: No evidence of causing oral mucosa irritation in Syrian hamsters. (Pass)
Skin Sensitization (ISO 10993-10:2010)	Result: No evidence of causing delayed dermal contact sensitization in guinea pig. (Pass)
Subacute Systemic Toxicity (ISO 10993-11:2017)	Result: Did not induce subacute systemic toxicity in rats. (Pass)
Subchronic Systemic Toxicity (ISO 10993-11:2017)	Result: No obvious histopathological difference in test and control groups; normal structure of organs, no abnormal histopathological changes. (Pass)
Acute Systemic Toxicity (ISO 10993-11:2017)	Result: No evidence of causing acute systemic toxicity in ICR mice. (Pass)
In Vitro Mammalian Cell Gene Mutation (ISO 10993-3:2014)	Result: Considered non-mutagenic. (Pass)
Micronucleus (ISO 10993-3:2014)	Result: Extract did not induce potential genotoxicity in ICR mice. (Pass)
Bacterial Reverse Mutation (ISO 10993-3:2014)	Result: No potential mutagenesis (number of reverting colonies not equal to or greater than spontaneous control). (Pass)
Muscle Implant (ISO 10993-6:2016)	Result: Did not induce local effects after implantation of biomaterials in rabbits. (Pass)

2. Sample Size and Data Provenance for Test Set

The document does not provide specific sample sizes for the "test set" in the context of clinical performance or diagnostic accuracy, as this is a material rather than a diagnostic AI device. The testing described is for material properties and biocompatibility.

Sample Size (Material Properties): Not explicitly stated, but implies a sufficient number of samples were tested to meet the requirements of ISO 6872.
Sample Size (Biocompatibility): Not explicitly stated, but animals were used for various tests (e.g., Syrian hamsters, guinea pigs, rats, ICR mice, rabbits), indicating standard biological testing protocols.
Data Provenance: The studies were performed by or for Changsha Honchon Technology Co., LTD, located in China. The provenance of the raw materials (zirconia powder, inorganic pigments) is not specified, but the compliance with ISO standards indicates internationally recognized quality control. The studies are prospective bench and biological tests conducted for the purpose of this submission.

3. Number of Experts and Qualifications for Ground Truth (Test Set)

This information is not applicable as the device is a dental material, not a diagnostic device requiring expert interpretation of images or clinical data for ground truth establishment. The "ground truth" for material properties is defined by the objective measurements according to the specified ISO standards, and for biocompatibility by the biological responses observed in controlled animal and in-vitro studies.

4. Adjudication Method for Test Set

This information is not applicable as there is no human interpretation or diagnostic decision-making being assessed that would require adjudication.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

This information is not applicable as this is a dental material, not a diagnostic AI device requiring a human-in-the-loop performance study.

6. Standalone (Algorithm Only) Performance Study

This information is not applicable as this is a dental material, not an AI algorithm. The performance studies are entirely standalone in the sense that they evaluate the material itself against predefined criteria.

7. Type of Ground Truth Used

Material Properties: The "ground truth" is established by objective measurements and analyses against the specifications outlined in ISO 6872:2015 for various material characteristics (radioactivity, flexural strength, chemical solubility, linear thermal expansion coefficient, freedom from extraneous materials, uniformity, shrinkage factor, pre-sintered density, sintered density, and fracture toughness).
Biocompatibility: The "ground truth" is established by observed biological responses (e.g., cytotoxicity, irritation, sensitization, systemic toxicity, genotoxicity, local effects) in controlled in-vitro and in-vivo studies conducted according to ISO 10993-1:2018 and ISO 7405:2018, and specific parts of ISO 10993 (e.g., ISO 10993-3, -5, -6, -10, -11).

8. Sample Size for Training Set

This information is not applicable as this device is a material, not an AI-powered device that requires a training set.

9. How Ground Truth for Training Set was Established

This information is not applicable as this device is a material, not an AI-powered device that requires a training set.

Summary

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July 8, 2022

Changsha Honchon Technology 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: K221051

Trade/Device Name: 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: April 11, 2022 Received: April 11, 2022

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,

Srinivas Nandkumar, Ph.D. 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) K221051

Device Name

Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank

Indications for Use (Describe)

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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Section 5 - 510(k) Summary

1. Submitter's Identifications

Submitter's Name: Changsha Honchon Technology Co., LTD Address: Room 627-628, Building 3th, Jinqiao Market Cluster Area 2, Purui Road No.1555. Wangcheng Economic and Technological Development Zone, Changsha, Hunan, China Zip Code: 410200 Contact Person: Ling Li Contact Title: General Manager Contact E-mail Address: tech(@honchon.com Tel: +86-731-85529297

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: Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank Model: HS, HT, HT-C, HT-Plus, HTP-C, ST, ST-Plus, STP-C, ST-ML, SHT, SHT-C, SHT-ML, 3D-ML, 3D-Plus-ML, 3D-Pro-ML, 4D-ML, 4D-Plus-ML, 4D-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

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

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5. Device Description

6. Intended Use of Device

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.

7. Summary of Substantial Equivalence

	Proposed Device	Predicate device	Comparison
510k Number		K141724	------
Product Code	EIH	EIH	Same
Proprietary Name	Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank	Upcera Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank	------
Model	HS, HT, HT-C,HT-Plus, HTP-C,ST, ST-C, ST-Plus,STP-C, ST-ML,SHT, SHT-C,SHT-ML, 3D-ML,3D-Plus-ML,3D-Pro-ML,4D-ML,4D-Plus-ML	------	------

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	4D-Pro-ML, UT,UT-C, UT-ML
Manufacturer	Changsha HonchonTechnology Co.,LTD	Liaoning UpceraCompany Limited	------
Indications forUse	Dental ZirconiaBlank & DentalZirconiaPre-Shaded Blankare used for dentalrestorations usingdifferentCAD/CAM ormanual millingmachines. Allblanks areprocessed thoughtdental laboratoriesor by dentalprofessionals.	Upcera DentalZirconia Blank &Dental ZirconiaPre-Shaded Blankare used for dentalrestorations usingdifferentCAD/CAM ormanual millingmachines. Allblanks areprocessed thoughtdental 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

Changsha Honchon Technology Co., LTD
--------------------------------------	--	--	--

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Sterile	Non-sterile	Non-sterile	Same
----------------	-------------	-------------	------

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 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 & 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.	Pass
	Under the conditions of this study, the test articlewas None cytotoxic and was accepted in the agardiffusion .
	Under the conditions of this study, the test articlehas no potential toxicity to L-929 cells.
Oral Mucosa Irritation(ISO 10993-10:2010)	The test article showed no evidence of causingoral mucosa irritation in the Syrian hamsters.	Pass
SkinSensitization(ISO 10993-10:2010)	The test article showed no evidence of causingdelayed dermal contact sensitization in the guineapig.	Pass

		Table 2 Biocompatibility testing
--	--	----------------------------------	--

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Subacute SystemicToxicity(ISO 10993-11:2017)
Subacute SystemicToxicity(ISO 10993-11:2017)	The test result showed that the test article did notinduce subacute systemic toxicity in rats underthis condition .	Pass
Subchronic SystemicToxicity(ISO 10993-11:2017)	There is no obvious histopathological difference intest group and control group. The structure of eachargan in test group is normal, no abnormalhistopathological changes in the table above wasfound.	Pass
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 Mutation(ISO 10993-3:2014)	Under the conditions of this study, the test articleis considered non-mutagenic.	Pass
Micronucleus(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
Bacterial ReverseMutation(ISO 10993-3:2014)	Under the conditions of this study, the number ofreverting colonies in the test article group is notequal to or greater that of the spontaneous control,so the test article have no potential 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 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 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. 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.