Glass Ceramic are indicated for fabricating all-ceramic restorations such as veneers, inlays, onlays, crowns, 2-unit anterior bridges, using the CAD/CAM system.

Device Description

Glass Ceramic is indicated for fabricating all ceramic restorations such as veneers, inlay/ onlay, partial crowns, anterior crowns, posterior crowns, using the CAD/CAM system.

The Glass Ceramic is composed of SiO2, Li2O, K2O, P2O5, Al2O3 and other oxides, the performance of the Glass Ceramic conforms to ISO 6872: 2015 Dentistry: Ceramic Materials.

The Glass Ceramic is disposable device, and provided as non-sterile.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a dental Glass Ceramic device and outlines non-clinical tests conducted to demonstrate substantial equivalence to a predicate device. It does not contain information about a study involving human readers, AI assistance, or expert ground truth for image analysis.

Here's a breakdown of the available information regarding acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are primarily based on the ISO 6872:2015 standard for Dentistry: Ceramic Materials and relevant ISO 10993 standards for biological evaluation.

ITEM	Acceptance Criteria (from ISO Standard)	Reported Device Performance (K223194)	Remark
Performance (ISO 6872:2015)
Uniformity	No segregation of pigment(s) when the powder is mixed, check by visual inspection.	Conformance to requirements	SAME
Freedom from extraneous materials	Free from extraneous materials when assessed by visual inspection.	Conformance to requirements	SAME
Radioactivity	< 1.0Bq·g⁻¹ of ²³⁸U	< 1.0Bq·g⁻¹ of ²³⁸U	SAME
Biaxial flexure	Type II Class 2 > 100MPa	308.4MPa	Different 1 (Meets & Exceeds)
Linear thermal expansion coefficient	Shall not deviate by more than 0.5×10⁻⁶K⁻¹ from manufacturer's stated value.	10.8×10⁻⁶K⁻¹	SIMILAR
Glass transition temperature	Shall not deviate by more than 20°C from manufacturer's stated value.	553.5°C	Different 2 (Meets)
Chemical solubility	Type II Class 2 < 100µg·cm⁻²	9.5µg·cm⁻²	SIMILAR
Fracture toughness	Type II Class 2 > 1MPa√m	3.83MPa√m	Different 3 (Meets & Exceeds)
Biocompatibility (ISO 10993 series)
Cytotoxicity (Agar diffusion)	Conformance to requirements in ISO 10993-5	Conformance to requirements	SAME
Sensitization	Conformance to requirements in ISO 10993-10	Conformance to requirements	SAME
Acute systemic toxicity (Oral)	Conformance to requirements in ISO 10993-11 / ISO 10993-23	Conformance to requirements	SAME
Oral mucosa irritation	Conformance to requirements in ISO 10993-10	Conformance to requirements	SAME
Bacterial reverse mutation (Ames test)	Conformance to requirements in ISO 10993-3	Conformance to requirements	SAME

Study Proving Device Meets Acceptance Criteria:

The study conducted was a series of non-clinical tests to verify that the proposed device met all design specifications and was Substantially Equivalent (SE) to the predicate device. The results are summarized in Section 7 and further detailed in the comparison tables (Table 5-2 for Performance and Table 5-3 for Biocompatibility).

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

Sample Size: The document does not specify the exact sample sizes (e.g., number of test specimens) used for each non-clinical test. It only states that "Non clinical tests were conducted".
Data Provenance: The tests were conducted by the manufacturer, Shenzhen Xiangtong Co.,Ltd., in China, as implied by their address and the submission origin. The tests are non-clinical, so "retrospective or prospective" doesn't directly apply in the human data sense. It refers to laboratory testing of material properties.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This section is not applicable as the document describes non-clinical material testing, not a study involving human interpretation or ground truth establishment by medical experts for diagnostic purposes. The "ground truth" for these tests is defined by the objective measurement standards outlined in the ISO standards.

4. Adjudication Method for the Test Set

This section is not applicable as the document describes non-clinical material testing, not a study involving human interpretation or adjudication processes.

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

There was no MRMC comparative effectiveness study done. The device is a dental material (Glass Ceramic) used for restorations, not an AI-assisted diagnostic or imaging device.

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

This section is not applicable as the device is a physical material, not an algorithm.

7. The type of ground truth used

The "ground truth" for the non-clinical tests was established by objective measurement against the specified criteria and methodologies detailed in the referenced ISO standards (e.g., ISO 6872 for ceramic materials, ISO 10993 for biological evaluation). These standards define acceptable ranges and test methods for properties like biaxial flexure strength, chemical solubility, and biocompatibility.

8. The sample size for the training set

This section is not applicable. The document describes the testing of a manufactured material, not a machine learning model that requires a training set.

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

This section is not applicable for the same reason as above.

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). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which 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.

February 10, 2023

Shenzhen Xiangtong Co.,Ltd. % Ray Wang Gerneral Manager Beijing Believe-Med Technology Service Co., Ltd. Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd., FangShan District Beijing, Beijing 102401 CHINA

Re: K223194

Trade/Device Name: Glass Ceramic Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder For Clinical Use Regulatory Class: Class II Product Code: EIH Dated: December 12, 2022 Received: December 12, 2022

Dear Ray 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 (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.

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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 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.

Michael E. Adjodha -S

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)

K223194

Device Name Glass Ceramic

Indications for Use (Describe)

Glass Ceramic are indicated for fabricating all-ceramic restorations such as veneers, inlays, onlays, crowns, 2-unit anterior bridges, using the CAD/CAM system.

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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510(k) Summary

This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) Number:

1. Date of Preparation: 12/21/2022
1. Sponsor

SHENZHEN XIANGTONG CO.,LTD.

2nd Floor, 1st Building, West Area, Honghualing Industrial Park, No.88, North Zhuguang Rd, Nanshan District, Shenzhen, 518055, China. Contact Person: Xue Gong Position: Regulatory Affairs Tel: +86-13760477635 Email: gongx(@xianton.com

1. Submission Correspondent

Beijing Believe-Med Technology Service Co., Ltd.

Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd., FangShan District, Beijing, China,102401 Contact Person: Ray Wang Position: General Manager Tel: +86-18910677558 Fax: +86-10-56335780 Email: information@believe-med.com

4. Proposed Device Identification

Trade Name: Glass Ceramic Common Name: Powder, Porcelain Regulatory Information: Classification: II Product Code: EIH Regulation Number: 21 CFR 872.6660

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Regulation Name: Porcelain powder for clinical use Review Panel: Dental

Indication For Use Statement:

Glass Ceramic is indicated for fabricating all ceramic restorations such as veneers, inlay/ onlay, partial crowns, anterior crowns, posterior crowns, using the CAD/CAM system.

ર. Device Description
Glass Ceramic is indicated for fabricating all ceramic restorations such as veneers, inlay/ onlay, partial crowns, anterior crowns, posterior crowns, using the CAD/CAM system.

The Glass Ceramic is composed of SiO2, Li2O, K2O, P2O5, Al2O3 and other oxides, the performance of the Glass Ceramic conforms to ISO 6872: 2015 Dentistry: Ceramic Materials.

The Glass Ceramic is disposable device, and provided as non-sterile.

1. Predicate Device Identification

Predicate Device:

510(k) Number: K141727 Product Name: Dental Lithium Disilicate Glass Ceramic Block (Up. Press Series and Up. CAD Series) Manufacturer: Liaoning Upcera Co., Ltd

Reference Device:

510(k) Number: K051705 Product Name: IPS E.MAX CAD Manufacturer: Ivoclar Vivadent AG

7. Non-Clinical Test Conclusion

Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:

A ISO 10993-3: 2014 Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
♪ ISO 10993-5: 2009 Biological evaluation of medical device - Part 5: Tests for in vitro cytotoxicity

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ISO 10993-10: 2021 Biological evaluation of medical devices Part 10: Tests for skin > sensitization
ISO 10993-11: 2017 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
ISO 10993-23: 2021 Biological evaluation of medical devices Part 23: Tests for irritation A
ISO 6872: 2015 Dentistry Ceramic materials >
1. Clinical Test Conclusion

No clinical study is included in this submission.

Substantially Equivalent (SE) Comparison 9.

	Proposed Device (K223194)	Predicate Device (K141727)
ITEM		Dental Lithium Disilicate Glass Ceramic Block(Up. CAD Series)	Remark
Product Code	EIH	EIH	SAME
Regulation No.	21 CFR 872.6660	21 CFR 872.6660	SAME
Class	II	II	SAME
Indication forUse	Glass Ceramic is indicated forfabricating all ceramic restorationssuch as veneers, inlay/ onlay, partialcrowns, anterior crowns, posteriorcrowns, using the CAD/CAM system.	Dental Lithium Disilicate Glass Ceramic Blocks(Up. Press Series and Up. CAD Series) areindicated for fabricating all ceramic restorationssuch as veneers, inlay/ onlay, partial crowns,anterior crowns, posterior crowns, using the hotpress technique or CAD/CAM system.	SIMILAR
Materials	SiO2, Li2O, K2O, P2O5, Al2O3and other oxides	SiO2, Li2O, K2O, P2O5, Al2O3, B2O3,and other oxides	SIMILAR
Summary ofsizes and shapes	Various	Various	SAME
Shade	Various	Various	SAME
Single Use	Yes	Yes	SAME
Principle ofoperation	CAD/CAM	CAD/CAM (Up. CAD Series)	SAME
Sterile	Non-sterile	Non-sterile	SAME

Table 5-1 General Comparison

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ITEM	ProposedDeviceK223194	PredicateDeviceK141727	ReferenceDeviceK051705	Requirement of ISO 6872	Remark
Uniformity	Conformanceto requirements	Conformance torequirements	Conformanceto requirements	The inorganic pigment(s) used toproduce the colour of a fired dentalceramic and any organic colorants (forcolour coding) shall be uniformlydispersed throughout the dental ceramicmaterial and in powdered ceramicproducts, no segregation of thepigment(s) shall take place when thepowder is mixed as in ISO 6872:20157.1.3.Check by visual inspection.	SAME
Freedom fromextraneous materials	Conformanceto requirements	Conformance torequirements	Conformanceto requirements	Dental ceramic materials shall be freefrom extraneous materials whenassessed by visual inspection.	SAME
Radioactivity	< 1.0Bq·g⁻¹of ²³⁸U	< 1.0Bq·g⁻¹ of²³⁸U	< 1.0Bq·g⁻¹of ²³⁸U	Dental ceramic materials shall not havean activity concentration of more than1.0Bq·g⁻¹ of ²³⁸U. Test in accordancewith ISO6872:2015 7.22.	SAME
Biaxial flexure	308.4MPa	/	530MPa	Type II Class2 > 100MPa	Different 1
Linear thermalexpansion coefficient	10.8×10⁻⁶K⁻¹	(8.5-11)×10⁻⁶K⁻¹	/	The coefficient of thermal expansion ofthe ceramics shall not deviate by morethan 0,5×10⁻⁶K⁻¹ from the value statedby the manufacturer.	SIMILAR
Glass transitiontemperature	553.5°C	/	/	The glass transition temperature of theceramics shall not deviate by more than20 °C from the value stated by themanufacturer.	Different 2
Chemical solubility	9.5µg·cm⁻²	<100µg·cm⁻²	/	Type II Class2 < 100µg·cm⁻²	SIMILAR
Fracture toughness	3.83MPa√m	/	2.11MPa√m	Type II Class2 >1MPa√m	Different 3

	Table 5-2 Performance Comparison

Note: " / " means that it cannot be got.

Different 1:

The proposed device is different from K051705 on biaxial flexure strength, the proposed device is Type 2 Class 2. According to ISO 6872, the biaxial flexure strength of Type 2 Class 2 should be greater than 100MPa. We have conducted performance tests, and the test results show that Glass Ceramic can meet the requirements of Type 2 Class 2, so this difference does not increase any risk of effectiveness.

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Different 2:

We cannot get the glass transition temperature of predicate device, so the proposed device may be different from predicate device on glass transition temperature. According to ISO 6872, the glass transition temperature of the ceramics shall not deviate by more than 20°C from the value stated by the manufacturer. The glass transition temperature of ceramics specified by us is 555°C, and the test results of ISO 6872 show that the deviation does not exceed 20℃, so this difference does not increase any risk of effectiveness.

Different 3:

The proposed device is different from K051705 on fracture toughness. According to ISO 6872, the Fracture toughness of Type 2 Class 2 should be greater than 1MPaym. We have conducted performance tests, and the test results show that Glass Ceramic can meet the requirements of Type 2 Class 2 and the proposed device is better than K0511705 on fracture toughness, so this difference does not increase any risk of effectiveness.

ITEM	Proposed Device(K223194)	Predicate Device(K141727)	Standard	Remark
Cytotoxicity(Agar diffusion)	Conformance torequirements	Conformance torequirements	ISO 10993-5	SAME
Sensitization	Conformance torequirements	Conformance torequirements	ISO 10993-10	SAME
Acute systemic toxicity(Oral)	Conformance torequirements	Conformance torequirements	ISO 10993-11 /ISO 10993-23	SAME
Oral mucosa irritation	Conformance torequirements	Conformance torequirements	ISO 10993-10	SAME
Bacterial reverse mutation(Ames test)	Conformance torequirements	Conformance torequirements	ISO 10993-3	SAME

Table 5-3 Biocompatibility Comparison

10. Substantially Equivalent (SE) Conclusion

The conclusions drawn from the nonclinical tests demonstrate that the device is as safe, as effective, and performs as well as or better than the legally marketed device (K141727).

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.