Dental Glass Ceramics is composed of SiO2, Li2O, K2O,P2O5,Al2O3 and other oxides. The block is intended to be processed into the dental restorations such as crowns, bridges, veneers, inlays and onlays based on the anatomical rendering of the patient's teeth using CAD/CAM (computer aided design / computer aided manufacturing) method or manual milling method. The block is a single-use device and provided non-sterile.

The performance of the dental blanks conforms to ISO 6872, Dentistry - Ceramic materials.

AI/ML Overview

The provided document is a 510(k) Premarket Notification from the FDA for a dental material (Dental Glass Ceramics), not an AI/ML medical device. Therefore, it does not contain the information requested in your prompt regarding acceptance criteria and study details for an AI-powered device.

Specifically, the document focuses on demonstrating substantial equivalence of the Dental Glass Ceramics to a predicate device based on material properties, intended use, and biocompatibility, as per ISO 6872 and ISO 10993 standards. It includes:

A comparison table (Table 1) showing the proposed device and predicate device are "Same" across numerous characteristics like product code, classification regulation, indications for use, materials, crystallization state, device design, shades, single use, principle of operation, sterility, type/class per ISO 6872, mechanical properties (flexural strength, chemical solubility, radioactivity, linear thermal expansion, glass transition temperature) and biocompatibility.
Biocompatibility testing results (Table 2) demonstrating that the material passed cytotoxicity, oral mucosa irritation, skin sensitization, subacute systemic toxicity, acute systemic toxicity, in vitro mammalian cell gene mutation, bacterial reverse mutation, and muscle implant tests. These tests are standard for evaluating the safety of implantable or device-contacting materials.
A statement that no clinical study was included in the submission.

Therefore, it is impossible to extract the requested information about acceptance criteria for an AI device, sample sizes for test sets, expert ground truth establishment, MRMC studies, standalone performance, or training set details from this document. The nature of the device (dental material) and its regulatory pathway (510(k) for substantial equivalence to a material predicate) do not necessitate or include such information.

Summary

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December 21, 2023

Shenzhen Yurucheng Dental Materials 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: K233016

Trade/Device Name: Dental Glass Ceramics Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder For Clinical Use Regulatory Class: Class II Product Code: EIH Dated: September 22, 2023 Received: September 22, 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 (the 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 available 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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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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).

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Sincerely,

Michael E. Adjodha -S

Michael E. Adjodha, MChE, RAC, CQIA 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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Indications for Use

510(k) Number (if known)

K233016

Device Name Dental Glass Ceramics

Indications for Use (Describe)

Once finalized into a suitable design, the Dental Glass Ceramics are indicated for use as inlays, onlays, veneer, partial crowns and crowns.

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

K233016

Date of Summary Preparation: September 22, 2023 Date of Modification: December 21, 2023

1. Submitter's Identifications

Submitter's Name: Shenzhen Yurucheng Dental Materials Co., Ltd. 1. Address: 101-201, Building 4, No.1 Branch of Zhongcheng Life Science Park, No. 14 Zhongxing Road, Xiuxin Community, Kengzi Street Office, Pingshan District, Shenzhen, China. Zip Code: 518122 Contact Person: Hongfei Liao Contact Title: Registered Manager Contact E-mail Address: system(@yucera.com Tel: +86-755-84622395

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 Glass Ceramics Model: HT, LT, ML-HT, ML-LT 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: K202952 Amber Mill Q Series and Amber Mill Direct Series HASS CORP

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5. Device Description

The performance of the dental blanks conforms to ISO 6872, Dentistry - Ceramic materials.

6. Intended Use of Device

Once finalized into a suitable design, the Dental Glass Ceramics are indicated for use as inlays,

onlays, veneer, partial crowns and crowns.

7. Summary of Substantial Equivalence

	Proposed Device	Predicate device	Comparison
510k Number		K202952	------
Product Code	EIH	EIH	Same
Classification Reg	21 CFR 872.6660	21 CFR 872.6660	Same
Proprietary Name	Dental GlassCeramics	Amber Mill QSeries and AmberMill Direct Series	------
Model:	HT, LT, ML-HT,ML-LT	------	------
Manufacturer	ShenzhenYurucheng DentalMaterials Co., Ltd.	HASS CORP	------
Indications forUse	Once finalized intoa suitable design,the Dental GlassCeramicsareindicated for use asinlays, onlays,veneer, partialcrowns andcrowns.	Once finalized intoa suitable design,the Amber Mill QSeries and AmberMill Direct Seriesare indicated foruse asinlays, onlays,veneer, partialandcrowns	Same
		crowns.
Materials	SiO2,Li2O,K2O,P2O5,Al2O3and other oxides	SiO2, Li2O,K2O,P2O5,Al2O3and other oxides	Same
CrystallizationState as Supplied	Fully crystallized	Fully crystallized	Same
Device Design	Block	Block	Same
Various	VariousTranslucency :Hightranslucency(HT)Lowtranslucency(LT)MediumOpacity(MO)	VariousTranslucency :Hightranslucency(HT)Lowtranslucency(LT)MediumOpacity(MO)	Same
Shades	Shade :LT/ HT : 16 A-Dand 4BleachMO : 5 MO0- MO4	Shade :LT/ HT : 16 A-Dand 4BleachMO : 5 MO0- MO4	Same
Single Use	Yes	Yes	Same
Principle ofOperation	Fabricatingrestorationsusing CAD/CAMsystem	Fabricatingrestorationsusing CAD/CAMsystem	Same
Sterile	Non-sterile	Non-sterile	Same
Type/Class perISO 6872	Type II , Class 3	Type II , Class 3	Same
Flexural strength	> 300MPa(meetingtheISO6872requirements)	> 300MPa(meetingtheISO6872requirements)	Same
Chemicalsolubility	< 100 ug / cm2(meetingtheISO6872requirements)	< 100 ug / cm2(meetingtheISO6872requirements)	Same
Freedom fromExtraneousMaterial	Shall be free fromextraneousmaterialswhenassessed byvisualinspection	Shall be free fromextraneousmaterialswhenassessed byvisualinspection	Same
	(meetingISO 6872requirements)	(meetingISO 6872requirements)
Radioactivity	Activityconcentration ofuranium238 lessthan 1.0Bq g-1(meeting theISO6872requirements)	Activityconcentration ofuranium238 lessthan 1.0Bq g-1(meeting theISO6872requirements)	Same
Linear of thermalexpansion	$10.5 \pm 0.5 \times 10^{-6}/\degree C$(meeting theISO6872requirements)	$11.5 \pm 0.5 \times 10^{-6}/\degree C$(meeting theISO6872requirements)	Same
Glass TransitionTemperature	Tg:500 ± 20 °C(meeting ISO 6872requirements)	Tg:500 ± 20 °C(meeting ISO 6872requirements)	Same
Biocompatibility	Non-toxic andbiocompatible(Meeting the ISO10993-3, 5, 10, 11and10993-6Requirements)	Non-toxic andbiocompatible(Meeting the ISO10993-3, 5, 10, 6and10993-11Requirements)	Same
Discussion forSubstantiallyEquivalent (SE)	The proposed device is essentially identical to the predicate devices in terms of indication for use, design between our device and the predicate devices
Item	Proposed device	Result
Cytotoxicity(ISO 10993-5:2009)	Under the conditions of this study, the test articlewas non cytotoxic for 2 h and was Mildlycytotoxic for 24 h in the filter diffusion method.Under the conditions of this study, the test articlewas Slight cytotoxic and was accepted in the agardiffusion method.Under the conditions of this study, the test articlehas no potential toxicity to L-929 cells.	Pass
Oral Mucosa Irritation(ISO 10993-10:2010)	The test article has no potential oral mucosairritation in the Syrian hamsters.	Pass
Skin SensitizationTest(ISO 10993-10:2010)	The test article showed no evidence of causingdelayed dermal contact sensitization in the guineapig.	Pass
Subacute SystemicToxicity Test(ISO 10993-11:2017)	There is no obvious histopathological difference intest group and control group. The structure of eachorgan 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 MutationTest(ISO 10993-3:2014)	Under the conditions of this study, the test articleis considered non-mutagenic.	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 4Weeks Test(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
Muscle Implant 13Weeks Test(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

Table 1 Comparison to Predicate Device

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Shenzhen Yurucheng Dental Materials Co., Ltd.

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Shenzhen Yurucheng Dental Materials 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.

8. Summary of Non-Clinical Testing

Bench testing was performed per ISO 6872:2015 and internal procedures to ensure that the Dental Glass Ceramics met its specifications. All tests were verified to meet acceptance criteria. Test results on Product Code, Classification Reg, Indications for Use, Materials, Crystallization State as Supplied, Device Design, Shades , Single Use , Principle of Operation ,Sterile, Type/Class per ISO 6872, Flexural strength , Chemical solubility , Freedom from Extraneous Material , Radioactivity , Linear of thermal expansion , Biocompatibility and Glass Transition Temperature 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.

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According to ISO 10993-1:2018, we evaluated and conducted the compatibility test for the proposed device. The following table shows the biocompatibility testing results.

Table 2 Biocompatibility testing

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Note: Testing were Performed on Dental Glass Ceramics LT, with Pre-Shaded powder A4 (Due to the variety of Dental Glass Ceramics's models, LT-A4 with the most trace elements in type are selected as typical models for test) to cover the regular and Dental Glass Ceramics .

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 Glass Ceramics performs as well as or better than the legally marketed predicate device K202952 Dental Glass Ceramics. Dental Glass Ceramics is substantial equivalent to the legally marketed predicate device K202952 Dental Glass Ceramics.

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.