Glass Ceramics are indicated for fabricating all-ceramic restorations such as veneers, inlay/onlay, partial crowns, anterior crowns, posterior crowns, using the hot press technique or CAD/CAM system.

Device Description

Glass Ceramics contains glass ceramic blocks for dental use. The main ingredients of the product include Silica: 55%~65%: Lithium oxide: 12%~25%: Alumina: 2%~12%; Potassium oxide: 2%~14%; Other oxides: 0%~10%. Through the digital scanning of teeth or tooth mold, 3D data of tooth mold can be obtained. According to this data, CAD design can be carried out to design porcelain block processing model. Then, a CNC machine tool was used to manufacture the all-porcelain denture crown by CAM according to the porcelain block processing model. After air sintering or vacuum sintering, the all-porcelain denture was made to achieve the strength and aesthetic effect required by clinical use.

AI/ML Overview

The provided text is a 510(k) Premarket Notification from the FDA regarding a dental device called "Glass Ceramics." It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving that the device meets specific acceptance criteria related to an AI/Software as a Medical Device (SaMD) product.

Therefore, the requested information for an acceptance criteria table and a study proving a device meets these criteria (especially concerning AI/ML performance metrics like sensitivity, specificity, AUC, or reader improvement with AI assistance, sample sizes for AI training/test sets, expert ground truth establishment, etc.) cannot be extracted from this document, as it is about a material (dental glass ceramics) and not an AI/SaMD product.

The document discusses:

Physical and Chemical Properties Tests: These are bench tests against standards like ISO 6872:2015 for properties like flexural strength, chemical solubility, coefficient of thermal expansion, and glass transition temperature.
Biocompatibility Tests: These tests follow ISO 10993 standards for cytotoxicity, sensitization, irritation, systemic toxicity, subchronic toxicity, and genotoxicity.
No Clinical Performance Data: The document explicitly states "Clinical performance testing has not been performed for the subject device."
No mention of AI/ML: There is no indication that this device incorporates AI or machine learning.

Summary of why the requested information cannot be provided:

The input document describes a physical medical device (dental glass ceramics) and its FDA 510(k) clearance process, which relies on demonstrating substantial equivalence to an existing predicate device based on physical, chemical, and biocompatibility properties. It does not involve AI or software performance metrics, clinical studies with human readers, or ground truth establishment in the context of diagnostic or interpretive tasks.

To answer your prompt, I would need a document related to an AI/SaMD product, not a material science product.

Summary

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February 10, 2023

Yilink (Tianjin) Biotechnology Co., Ltd % Jennifer Liu Regulation Affairs Specialist Chenhe Medical Consulting Co., Ltd Room 113, 7th Floor, Block B, Building 1, No. A 38, Street, Haidian District Beijing, Beijing 100080 CHINA

Re: K222513

Trade/Device Name: Glass Ceramics Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder For Clinical Use Regulatory Class: Class II Product Code: EIH Dated: December 9, 2022 Received: December 12, 2022

Dear Jennifer Liu:

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 Quality Center for Devices and Radiological Health

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Indications for Use

510(k) Number (if known)

K222513

Device Name

Glass Ceramics

Indications for Use (Describe)

Glass Ceramics are indicated for fabricating all-ceramic restorations such as veneers, inlay/onlay, partial crowns, anterior crowns, posterior crowns, using the hot press technique or CAD/CAM system.

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

Prescription Use (Part 21 CFR 801 Subpart D)

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K222513 005_510 (k) Summary

This summary of 510(k) for the subjective device equivalence information is being submitted in accordance with the requirements of 21 C.F.R. 807.92.

1. Date Summary Prepared: Feb. 2, 2023

2. Contact details

2.1 Applicant information:

Name	Yilink (Tianjin) Biotechnology Co., Ltd.
Address	No 9 Kaituo Road, Balitai Town, Jinnan District, Tianjin City,300350, China
Tel:	0086- 022-88522665
Contact person and title:	Yaqiong Zhu, Engineering manager
E-mail	1039001641@qq.com

2.2 Submission Correspondent

Name	Chenhe Medical Consulting Co., Ltd
Address	Room 113, 7th Floor, Block B, Building 1, No. A 38,Zhongguancun Street, Haidian District, Beijing, China
Tel:	086 633 13774915658
Contact person and title:	Jennifer Liu/Regulatory Affairs Manager
E-mail	Jennifer19862022@163.com

3. Device Name

Trade name: Glass Ceramics

Common name: Dental Glass Ceramics

Classification name: Powder, Porcelain

Regulatory Class: II

Product Code: EIH

4. Predicate Device Information

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Table 1: Predicate Device Information
Owner/Operator	Device Trade Name	510 (k) No.	Product Code	Predicate
Aidite (Qinhuangdao)Technology Co., Ltd.	Dental Glass Ceramics Blocks	K192231	EIH	Primary

This predicate device has not been subject to a design-related recall. No reference devices were used in this submission.

5. Description of Device

6. Indications for Use

Glass Ceramics are indicated for fabricating all-ceramic restorations such as veneers, inlay/onlay, partial crowns, anterior crowns, posterior crowns, using the hot press technique or CAD/CAM system.

7. Summary of Physical and Chemical Properties Tests

Test standards and methods based on ISO 6872:2015 (Dentistry - Ceramic materials) and internal final inspection standard of Yilink (Tianjin) Biotechnology Co., Ltd.. And the results from testing demonstrate that Glass Ceramics is substantially equivalent to the predicate device.

8. Technological Characteristics

All components of the subject device are based upon industry well-known chemistry. The following table shows the significant technological characteristics for the subject device and indicates the following similarities and differences with the predicate device:

Table 4: Technological Characteristics Comparison Table

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TechnologicalCharacteristics	Subject device	Primary predicate
	Glass Ceramics	Dental Glass Ceramics BlocksK192231
Product code	EIH	EIH
Indications for Use	Glass Ceramicss are indicated forfabricating all-ceramic restorations suchas crown, bridge, inlay, veneer.	Dental Glass Ceramics Blocks are indicatedfor fabricating all-ceramic restorations suchas veneers, inlay/onlay, partial crowns,anterior crowns, posterior crowns, using thehot press technique or CAD/CAM system.
Composition	SiO2, Li2O, K2O, Al2O3 and other oxides	SiO2, Li2O, K2O, Al2O3 and other oxides
Pressing at Dentallab	Hot Press (Up. Press Series)CAD/CAM (Up.CAD Series)	Hot Press (Up. Press Series)CAD/CAM (Up.CAD Series)
Dimension	Various	Various
Single use	Yes	Yes
Available Color	Various	Various
Sterile	Non-sterile	Non-sterile
	The subject device and the predicate device have substantially equivalent physicalproperty as they all conform to the specifications set by internal final inspection and thetest method equal to ISO 6872:2015.
Physical Properties	Item	Testing criteria	Subjectdevice/HT	Primarypredicate/HT
	Flexural strength	≥100MPa	356.7	348.9
	Chemical solubility	≤100µg·cm-2	25.3	28.5
	Coefficient ofthermal expansion	$( 11±0.5 ) ×10-6K-1(0-500°C )$	10.8	10.8
	Glass transitiontemperature	HT/MT: (520±20) °CLT: (510±20) °C	510	510

9. Summary of Biocompatibility

The new device, Glass Ceramicss, is substantially equivalent to the predicate devices that have been legally marketed for decades and with no clinical adverse events. The formulation of new device does not contain any non-conventional chemicals compared to the legally marketed predicate device. Biocompatibility tests were performed fully following the ISO 10993 standards. The test items include Cytotoxicity, Sensitization, Irritation, Systemic Toxicity, Subchronic Toxicity and Genotoxicity.

10. Clinical Performance Data

Not applicable. Clinical performance testing has not been performed for the subject device.

11. Non-clinical Testing

Bench testing was performed per ISO 6872:2015 and internal procedure to ensure that the Glass Ceramics

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met the specifications. All tests were verified to meet the acceptance criteria.

12. Conclusions

Based on the indications for use, technological characteristics, performance testing and comparison to predicate devices, the subject device has been shown to be safe and effective for its intended use and the minor differences in indications for use fall within the intended use of the predicate devices affecting neither the general intended use nor substantial equivalence. Yilink (Tianjin) Biotechnology Co., Ltd. concludes that the subject device is substantially equivalent to the predicate devices described herein.

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.