TopCEM-Try in Veneer Try-in Gel is primarily made of polyethylene glycol, inorganic fillers and pigments. It is used to indicate the color of the Light Cure Veneer Cement before use, so as to select the right color to achieve the best aesthetic effect. The polyethylene glycol and inorganic filler in the Veneer Try-in Gel component are hydrophilic and can be rinsed off with a water gun nozzle after the color test operation. The principal organic components of TopCEM-Try in Veneer Try-in Gel are mixtures of polyethylene glycol, and the inorganic fillers loading is about 50% by volume.

AI/ML Overview

The provided document is a 510(k) premarket notification for a dental product, TopCEM-Try in Veneer Try-in Gel. It concerns the substantial equivalence determination for this device, which means proving it is as safe and effective as a legally marketed predicate device.

The document does not describe an AI medical device or a study involving AI, machine learning, or human readers. Therefore, many of the requested details about acceptance criteria, test sets, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, and standalone performance are not applicable to this document.

However, I can extract the information that is provided regarding the device's performance based on the general format and content of the filing:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Stated as "Pass/fail criteria" or "internal standards")	Reported Device Performance (Conclusion)
Meet internal standards for Appearance	Satisfactory
Meet internal standards for Shade	Satisfactory
Meet internal standards for Liquidity	Satisfactory
Meet internal standards for Consistence	Satisfactory
Conform to HuGe internal inspection standard for Physical Properties	Substantially equivalent (to predicate)
Biological evaluation according to ISO 10993 standards and FDA guidance	Passed Cytotoxicity, Sensitization, and Irritation tests

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document refers to "Bench testing" performed on the subject device and the primary predicate device. It also states that biological evaluation (biocompatibility tests) was performed.

Sample size: Not specified.
Data provenance: Not specified, but the tests were performed by Rizhao HuGe Biomaterials Company, Ltd. in China. The nature of these tests (bench testing, biocompatibility) implies they are prospective tests conducted on manufactured samples.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. The "ground truth" for the physical and chemical properties as well as biocompatibility tests would be the established scientific and regulatory standards (e.g., ISO 10993 for biocompatibility, and the company's internal standards for physical properties). These do not typically involve human expert consensus in the same way an AI diagnostic device's ground truth would.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. Adjudication methods like 2+1 or 3+1 are used for establishing a consensus ground truth in studies involving human interpretation or subjective assessments, which is not the case for the type of bench testing and biocompatibility reported here.

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

Not applicable. This is not an AI medical device.

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

Not applicable. This is not an AI medical device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For physical and chemical properties: "HuGe internal inspection standard" for parameters like appearance, shade, liquidity, and consistence.
For biocompatibility: International Standard ISO 10993-1 and FDA guidance for biological evaluation of medical devices.

8. The sample size for the training set

Not applicable. There is no training set mentioned as this is not an AI/ML device.

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

Not applicable. There is no training set mentioned as this is not an AI/ML device.

Summary

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Image /page/0/Picture/0 description: The image contains 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.

December 20, 2024

Rizhao HuGe Biomaterials Company, Ltd. Maggie Zheng Regulatory Affairs Manager No.2 North Zhaoyang Road, District of Donggang Rizhao City, 276800 CHINA

Re: K242572

Trade/Device Name: TopCEM-Try in Veneer Try-in Gel Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: Class II Product Code: EBF Dated: November 25, 2024 Received: November 25, 2024

Dear Maggie Zheng:

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.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

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 medical devices and radiation-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-regulatory

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assistance/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, 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

Submission Number (if known)

K242572

Device Name

TopCEM-Try in Veneer Try-in Gel

Indications for Use (Describe)

TopCEM-Try in Veneer Try-in Gel is used to evaluate the shade and the matching of the restoration prior to permanent cementation.

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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K242572 - 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: December 16, 2024

2. Submitter Information:

Owner's Name	Rizhao HuGe Biomaterials Company, Ltd.
Address	No.2 North Zhaoyang Road, District of Donggang, Rizhao City,Shandong Province, China 276800
Telephone	0086 633 2277268
Fax	0086 633 2277298
Contact Person	Ms. Maggie Zheng
Contact Title	Regulatory Affairs Manager
E-mail	zhengxy@hugedent.com

3. Device Name

Trade name: TopCEM-Try in Veneer Try-in Gel Common name: Veneer Try-in Gel Classification name: Material, Tooth Shade, Resin Regulation Number: 21 CFR 872.3690 Regulatory Class: II Product Code: EBF

4. Predicate Device Information

Owner/Operator	Predicate Device TradeName	510 (k)No.	ProductCode	ClassificationName	RegulationNumber	Predicate
Ivoclar VivadentAG	Variolink Esthetic Try-In	K142389	EBF	Material, ToothShade, Resin	872.3690	Primary
3M Company	3M RelyX Veneer CementTry-in Paster	K002452	EMA	Cement, Dental	872.3275	Reference

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5. Description of Device

The principal organic components of TopCEM-Try in Veneer Try-in Gel are mixtures of polyethylene glycol, and the inorganic fillers loading is about 50% by volume.

6. Indications for Use

TopCEM-Try in Veneer Try-in Gel is used to evaluate the shade and the matching of the restoration prior to permanent cementation.

7. Summary of Physical and Chemical Properties Tests

The physical properties of the subject device were determined and tested according to HuGe internal inspection standard. Bench testing was performed on the subject device and the primary predicate device, the test results demonstrated the substantial equivalence when compared to the primary predicate device.

Summary of Physical and Chemical Properties Test
Items per internal standards	Pass/fail criteria	Conclusion
Appearance	Meet internal standards.	Satisfactory
Shade	Meet internal standards.	Satisfactory
Liquidity	Meet internal standards.	Satisfactory
Consistence	Meet internal standards.	Satisfactory

8. Technological Characteristics Comparison

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 devices:

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Technological Characteristics Comparison Table
TechnologicalCharacteristics	Subject deviceTopCEM-Try in VeneerTry-in Gel(K242572)	Primary predicate deviceVariolink Esthetic Try-in(K142389)	Reference predicatedevice3M RelyX VeneerCement Try-in Paster(K002452)
	Main components	TopCEM-Try in Veneertry-in gel is primarily madeof polyethylene glycol,colorant, inorganic fillersand pigments.	The Variolink EstheticTry-In pastes containglycerine, mineral fillersand inorganic fillers.	RelyX Try-In pastecontains polyethyleneglycol (PEG),zirconia/silica filler andpigments.
	Physical Form	Paste	Paste	/
Water solubility	Hydrophilic	Hydrophilic	/
Indications of Use	TopCEM-Try in VeneerTry-in Gel is used toevaluate the shade and thematching of therestoration prior topermanent cementation.	To evaluate the overalleffect of the restorationin conjunction with thevarious VariolinkEsthetic shades prior topermanent cementation.	/
Prescription/over-the-counter use	Prescription	Prescription	/
Delivery form	Packed in syringe	Packed in syringe	/
Storage Condition	Store TopCEM-Try inVeneer Try-in Gel at 2-25°C and away from directlight.	Storage temperature:2-28 °C / 36-82 °F.	/
Physical Properties	The subject and the primary predicate device havesubstantially equivalent physical properties as they allconform to HuGe internal inspection standard.		/

The indications of the subject device are similar to that of 510(k) cleared primary predicate device. Based on the indications for use in comparison to primary predicate device, the subject device has demonstrated substantial equivalence to the predicate device.

Based on HuGe internal inspection standard, technological characteristics, physical properties, performance testing are carried to compare the subject device with primary predicate device. According to test results, the subject device has similar technological characteristics with the primary predicate device.

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9. Summarv of Biocompatibility

The subject device is substantially equivalent to the predicate devices. The compositions of the subject device do not contain any non-conventional chemicals compared to the legally marketed predicate devices.

Biocompatibility tests were performed fully following the ISO 10993 standards and the FDA guidance titled "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process."" The test endpoint studies include cytotoxicity, sensitization, and irritation.

10. Clinical Performance Data

Clinical test is not applicable.

11. Conclusions

Based on the indications for use, technological characteristics, performance testing and comparison to predicate devices, the subject device has demonstrated substantial equivalence. The minor differences in indications for use between the subject and predicate device does not affect the general intended use or substantial equivalence. Rizhao HuGe Biomaterials Company, Ltd. concludes that the subject device is substantially equivalent to the predicate devices described herein.

Regulation Number and Section

§ 872.3690 Tooth shade resin material.

(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.