Dental Glass Ceramics Blocks 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

Dental Glass Ceramics Blocks are derived from dental porcelain powder that has been processed into their final net shapes. These blanks are then being further fabricated (using hot press or CAD/CAM technologies) into all-ceramic restorations such as veneers, inlay/ onlay, partial crowns, anterior crowns, posterior crowns. The ceramics material is composed of SiO2, Li2O, K2O3 and other oxides. It also contains inorganic pigments to provide different shades on the product surface. It has three model: HT,LT,ST, and totally 23 colors(A1,A2,A3,A3.5,A4,B1,B2,B3,B4,C1,C2, C3,C4,D2,D3,D4,BL1,BL2,BL3,BL4, OM1, OM2 and OM3).

AI/ML Overview

This FDA 510(k) summary is for a dental device (Dental Glass Ceramics Blocks) and focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study report with acceptance criteria and performance metrics for a novel AI/software device. Therefore, much of the requested information regarding AI/software performance studies (like sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and training set details) is not applicable to this document.

However, I can extract the relevant information regarding acceptance criteria and device performance based on the provided text for this specific type of medical device.

Device Name: Dental Glass Ceramics Blocks (HT,LT,ST)

Acceptance Criteria and Reported Device Performance:

Criterion Type	Acceptance Criteria (Standard)	Reported Device Performance
Physical & Mechanical Properties	ISO 6872:2015/AMD 1:2018 (Dentistry: Ceramic Materials) requirements	"Conforms to ISO 6872:2015/AMD 1:2018" and "met the requirements of ISO 6872"
Biocompatibility	ISO 10993-1:2018, FDA Guidance	"Comply with ISO 10993-1:2018, FDA Guidance"
Radioactive	ISO 6872:2018 requirements	"Meet the requirements of ISO 6872:2018"

Study to Prove Device Meets Acceptance Criteria:

A non-clinical test and biocompatibility testing were conducted.

Physical and mechanical properties of the subject device were evaluated according to ISO 6872:2015/AMD 1:2018. This standard classifies the device into:
- Type II: All other forms of ceramic products.
- Class 4: Monolithic ceramic for prostheses involving partially or fully covered substructure.
- The document states that the new model "ST" and the existing models (HT, LT, which correspond to the predicate device's models) were tested and found to have physical/mechanical properties that met the requirements of ISO 6872.
Biocompatibility testing was performed to verify the equivalent safety of the materials used. The results comply with ISO 10993-1:2018 and FDA Guidance.

Information Not Applicable to this Submission (as it is not an AI/software device):

Sample size used for the test set and data provenance: Not applicable. This is a physical material device, not a software/AI system. The testing involved material properties, not a "test set" of data in the AI sense.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for material properties is established by standardized physical and chemical testing, not expert consensus on medical images or patient data.
Adjudication method for the test set: Not applicable.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable. This is not an AI-assisted diagnostic or predictive device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used: For material properties, the "ground truth" is defined by the objective measurements obtained through standardized physical, mechanical, and chemical tests to meet the specified ISO standard. For biocompatibility, it's defined by compliance with ISO 10993-1 and FDA guidance through specific biological evaluation tests.
The sample size for the training set: Not applicable (no AI/machine learning involved).
How the ground truth for the training set was established: Not applicable.

Summary

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July 12, 2024

Aidite (Qinhuangdao) Technology Co., Ltd. % Boyle Wang General Manager Shanghai Truthful Information Technology Co., Ltd. Room 1801, No. 161 East Lu Jiazui Rd., Pudong, 200120 China

Re: K241715

Trade/Device Name: Dental Glass Ceramics Blocks (HT,LT,ST) Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder For Clinical Use Regulatory Class: Class II Product Code: EIH Dated: June 14, 2024 Received: June 14, 2024

Dear Boyle 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 (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.

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"

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(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 OS 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).

Sincerely.

Bobak Shirmohammadi -S

For Michael E. Adjodha. MChE, RAC, COIA Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia,

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Enclosure

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Indications for Use

Submission Number (if known)

K241715

Device Name

Dental Glass Ceramics Blocks (HT,LT,ST)

Indications for Use (Describe)

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

K241715

This summary is submitted in accordance with 21 CFR 807.92.

1.0 Submission Sponsor

Name:	Aidite (Qinhuangdao) Technology Co., Ltd.
Address:	No.9 Dushan Road, Economic and Technological Development ZoneQinhuangdao City, China 066004
Contact:	Mr.Xu Jinzhong
Tel:	+86 335 8587898
Fax:	+86 335 8587198

Designated Submission Correspondent

Contact:	Mr. Boyle Wang
Address:	Shanghai Truthful Information Technology Co., Ltd.Room 1801, No. 161 East Lu Jiazui Rd., Pudong Shanghai200120 China
Tel:	+86-21-50313932
Email:	info@truthful.com.cn

Date of Preparation: Jul.11,2024

2.0 Device Information

Trade name:	Dental Glass Ceramics Blocks
Common name:	Dental Glass Ceramics
Classification name:	Porcelain powder for clinical use
Production code:	EIH
Regulation number:	21 CFR 872.6660
Classification:	Class II
Panel:	Dental

3.0 Identification of Predicate Device and Reference Device

Predicate Device:

K192231 510(k) Number: Trade/Product Name: Dental Glass Ceramics Blocks Aidite (Qinhuangdao) Technology Co., Ltd. Manufacturer:

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4.0 Device Description

The performance of Dental Glass Ceramics Blocks conforms to ISO 6872:2015/AMD 1:2018 Dentistry: Ceramic Materials.

5.0 Indication for Use Statement

6.0 Non-clinical Test Conclusion

Physical and mechanical properties of the subject device were evaluated according to ISO 6872:2015/AMD 1:2018.

According to ISO 6872, the subject device is classified into the following:

Type II: All other forms of ceramic products.

Class 4: Monolithic ceramic for prostheses involving partially or fully covered substructure

Biocompatibility testing was performed to verify the equivalent safety of the materials that are used.

7.0 Technological Characteristics

Principle of Operation

There is no change in the principle of operation as part of this submission from the previous clearance under K192231. The module still utilizes the same principles of operation for Dental Glass Ceramics Blocks governed by the following principles:

This product is made of silicon dioxide powder. It is made by high temperature melting, casting molding and high temperature nucleation. Professional dental restoration agencies make the forms fitting for patients by hot press moulding or CAD/CAM and

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install it into the place to be repaired after sintering. It gets excellent biocompatibility, aesthetic appearance after sintering.

8.0 Summary of Technological Characteristics of the Subject Device Compared to the Predicate Device

The subject device, Dental Glass Ceramics Blocks (Model: HT, LT, ST) and the predicate device Dental Glass Ceramics Blocks (Model: Hot press model and CAD/CAM model), have the following key similarities:

· Both devices have the same intended use
· Both devices have the same components and shades.
· Both devices are indicated for the same patient population
Both devices have the same principle of operation and mechanism of action

The modifications outlined in this subject device do not raise different questions of safety or effectiveness as demonstrated by performance testing using the same methods based on the FDA-recognized standard ISO 6872 that were utilized for the predicate device. Furthermore, these changes (1) do not affect the intended use or (2) alter the fundamental scientific technology of the device. The modified devices retain the same core technological characteristics as the predicate device.

9.0 Summary of Clinical Test

Clinical testing was not required for this submission.

10.0 Technological Characteristics and Substantial Equivalence

The following table shows similarities and differences of use, design, and material between our device and the predicate devices.

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Table1 General Device Characteristics Comparison Table
Item	Subject Device	Predicate device	Remark
510(k) No.	K241715	K192231	--
Product Name	Dental Glass Ceramics Blocks	Dental Glass Ceramics Blocks	--
Product Code	EIH	EIH	Same
Regulation No.	872.6660	872.6660	Same
Class	II	II	Same
IntendedUse/Indicationfor Use	Dental Glass Ceramics Blocksare indicated for fabricatingall-ceramic restorations such asveneers, inlay/onlay, partialcrowns, anterior crowns,posterior crowns, using the hotpress technique or CAD/CAMsystem.	Dental Glass Ceramics Blocksare indicated for fabricatingall-ceramic restorations suchas veneers, inlay/onlay, partialcrowns, anterior crowns,posterior crowns, using thehot press technique orCAD/CAM system.	Same
Prescription Use	Yes	Yes	Same
Shapes	Blocks	Blocks	Same
Color	Various Color	Various Color	Same
Materials	SiO2, Li2O, K2O, Al2O3 andother oxides	SiO2, Li2O, K2O, Al2O3 andother oxides	Same
Dimension	Various	Various	Same
Processing atDental lab	Hot Press (Up. Press Series)CAD/CAM (Up.CAD Series)	Hot Press (Up. Press Series)CAD/CAM (Up.CAD Series)	Same
Model	HT, LT, ST	Hot press model,CAD/CAM model	Different*
Density(g/cm³)
FlexuralStrength(MPa)
Radioactive(Bq·g⁻¹)	Meet the requirements of ISO6872:2018	Meet the requirements of ISO6872:2018	Same
Coefficient ofThermalExpansion (K-1)
Glass TransitionTemperature(°C)
Single Use	Yes	Yes	Same
Sterile	Non-sterile	Non-sterile	Same
Biocompatibility	Comply with ISO 10993-1:2018,FDA Guidance	Comply with ISO 10993-1,FDA Guidance	Same

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Analysis*:

The subject device is same to the predicate device in terms of indications for use, design, material and processing.

The subject device is different from the predicate device in the following:

1. The model name has been changed for the subject device from the predicate device. Specifically, the predicate device's model name "Hot press model" has been changed to "HT model," and the model name "CAD/CAM model" has been changed to "LT model." It's just model name change, it has no effect on the substantial equivalence.
1. Add a new model "ST" to the predicate device's "CAD/CAM model."

HT model is high translucency ceramic block. LT model is low translucency ceramic block. And the new model is super translucency ceramic block.

The only difference between ST and LT and HT is their aesthetic effect, while the rest of their performance remains unchanged.

Physical and mechanical property of the new model ST is performed per ISO 6872. Both the subject device and the predicate device have same physical/mechanical properties that met the requirements of ISO 6872.

10.0 Conclusion

The conclusions drawn from the comparison and analysis above demonstrate that the subject device is substantially equivalent to the legally marketed predicated device.

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.