· Permanent cementation of all sorts of dental restorations including crowns, bridges, inlays/onlays, veneers and other restorations made from materials of metals/alloys, metal-ceramic and/or porcelain, composites, and their combinations.
· Permanent cementation for all types of root canal posts.
· Core build-ups.

Device Description

TopCEM Dual Cure Resin Cement is a versatile and ultimate dental dual cure (chemical and/or light cure) luting cement containing paste-paste of Base and Catalyst. The mixing ratio, based on volume, is 1 part base paste : 1 part catalyst paste. It is also a core build up material in syringes. The principal organic components are mixtures of dental methacrylate resins (TEGDMA, EBPADMA and UDMA). The inorganic filler loading is about 40% by volume having particle size range of about 0.01 to 3 microns. TopCEM Dual Cure Resin Cement is delivered in either two separated single syringes for Hand-mix or double-barrel syringes for Automix and comes in seven shades: TR (Translucent), A0 (Light+), A1 (Light), A2 (Medium), A3 (Dark), White Opaque) and Opaque (Universal Opaque). TopCEM Dual Cure Resin Cement is radiopaque, allowing for easy identification on radiographs. It belongs to Type 2 Class 3 dual cure materials in accordance with ISO 4049. The curing mechanism of the predicate devices and subject device is polymerization of uncured methacrylate ester monomers. This reaction is caused by photo initiator and chemical polymerization initiator systems.

AI/ML Overview

The provided text describes the 510(k) premarket notification for a dental product called "TopCEM Dual Cure Resin Cement" and its substantial equivalence to predicate devices. This document refers to the safety and efficacy of a material (dental cement), not a device in the context of an AI/ML-based diagnostic or imaging device.

Therefore, the requested information regarding acceptance criteria and studies that prove a device meets criteria (such as sample sizes, expert-established ground truth, MRMC studies, standalone performance, training set details, etc.) is not applicable to this document.

The document focuses on the physical, chemical, and biocompatibility properties of the dental cement, demonstrating its similarity to existing, legally marketed predicate devices through bench testing and adherence to international standards (ISO 4049, ISO 29022) and FDA guidance for dental composite resin devices.

Key points from the document relevant to its acceptance:

Acceptance Criteria for the Dental Cement: The acceptance criteria for this dental cement are based on adherence to specific physical and chemical property standards outlined in ISO 4049 and ISO 29022, as well as FDA guidance for dental composite resin devices.
- ISO 4049: This standard specifies requirements for resin-based dental restorative materials.
- ISO 29022: This standard specifies test methods for the evaluation of bond strength of dental adhesive systems.
- FDA Guidance: "Guidance for Industry and FDA Staff Dental Composite Resin Devices - Premarket Notification [510(k)] Submissions Document issued on: October 26, 2005."
Demonstration of Performance: The device's performance was demonstrated through bench testing against these established standards and internal company standards.
Substantial Equivalence: The primary method of acceptance is demonstrating "substantial equivalence" to legally marketed predicate devices, meaning it is as safe and effective as a legally marketed device. This is primarily established by comparing:
- Indications for Use
- Technological Characteristics (monomer matrix, fillers, physical form, curing method, delivery form, radiographic appearance)
- Physical/Chemical Properties (conformance to ISO standards)
- Biocompatibility (conformance to ISO 10993 standards)

Table of Acceptance Criteria and Reported Device Performance (as presented in the document for TopCEM Dual Cure Resin Cement):

Items per ISO 4049/ISO 29022	Pass/fail criteria	Reported Device Performance
ISO 4049 5.2.2 Film thickness, luting materials	The film thickness of luting materials in any event shall be no greater than 50 µm.	Satisfactory
ISO 4049 5.2.4 Working time, Class 1 and Class 3 luting materials	The material shall be capable of forming a thin layer; during its formation there shall be no detectable change in its homogeneity, shall be not less than 60 s.	Satisfactory
ISO 4049 5.2.6 Setting time, Class 3 materials	The setting time shall be not more than 10 min.	Satisfactory
ISO 4049 5.2.9 Flexural strength	The flexural strength shall be equal to or greater than 50 MPa.	Satisfactory
ISO 4049 5.2.10 Water sorption and solubility	The water sorption shall be ≤ 40 µg/mm³. The solubility of shall be ≤ 7.5 µg/mm³.	Satisfactory
ISO 4049 5.5 Radio-opacity	The radio-opacity shall be equal to or greater than that of the same thickness of aluminium (1 mm of material).	Satisfactory
Shear bond strength (ISO 29022)	Meet internal standards.	Satisfactory
Bonding durability (ISO 29022)	Meet internal standards.	Satisfactory
Compressive strength Flexural strength Elastic modulus	Meet internal standards.	Satisfactory

Regarding the specific questions about device performance as if it were an AI/ML device:

AI/ML Acceptance Criteria/Performance Table: Not applicable. The device is a dental cement, evaluated by material properties, not AI/ML metrics like sensitivity, specificity, or AUC.
Sample sizes for test set and data provenance: Not applicable. No test set of medical images or patient data was used. Performance was based on bench tests of material samples.
Number of experts and qualifications for ground truth: Not applicable. Ground truth was established by physical, chemical, and biocompatibility testing according to ISO standards, not expert clinical interpretation.
Adjudication method: Not applicable. Material properties are objectively measured, not subject to adjudication.
MRMC comparative effectiveness study: Not applicable. No human readers or AI assistance in a diagnostic context.
Standalone (algorithm only) performance: Not applicable. The device is a material, not an algorithm.
Type of ground truth used: Bench test results from standardized physical, chemical, and biocompatibility tests.
Sample size for training set: Not applicable. There is no software or AI model to train.
How ground truth for training set was established: Not applicable.

In conclusion, the provided document clearly details the regulatory submission and acceptance of a dental material based on its chemical, physical, and biocompatibility properties, demonstrating substantial equivalence to predicate devices through standardized bench testing. It does not relate to the performance of an AI/ML-based medical device.

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). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".

December 22, 2023

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

Re: K233082

Trade/Device Name: TopCEM Dual Cure Resin Cement Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: Class II Product Code: EBF, EMA Dated: September 25, 2023 Received: September 26, 2023

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.

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).

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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 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-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, M.ChE., RAC, CQIA Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices

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Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

Submission Number (if known)

K233082

Device Name

TopCEM Dual Cure Resin Cement

Indications for Use (Describe)

· Permanent cementation for all types of root canal posts.
· Core build-ups.

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 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 1, 2023

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 Dual Cure Resin Cement Common name: Dual Cure Resin Cement Classification name: Material, Tooth Shade, Resin (21 CFR 872.3690) Regulatory Class: II Product Code: EBF, EMA

4. Predicate Device Information

Owner/Operator	Device Trade Name	510 (k) No.	Product Code	Predicate
COLTENE/WHALEDENTAG	PARAPOST PARACOREAUTOMIX 5ML	K052820	EBF	Primary
Rizhao HuGe BiomaterialsCompany, Ltd.	Dual Cure Resin Cement	K201790	EMA, EBF	Secondary

These predicate devices have not been subject to a design-related recall.

No reference device were used in this submission.

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5. Description of Device

The principal organic components are mixtures of dental methacrylate resins (TEGDMA, EBPADMA and UDMA). The inorganic filler loading is about 40% by volume having particle size range of about 0.01 to 3 microns.

TopCEM Dual Cure Resin Cement is delivered in either two separated single syringes for Hand-mix or double-barrel syringes for Automix and comes in seven shades: TR (Translucent), A0 (Light+), A1 (Light), A2 (Medium), A3 (Dark), White Opaque) and Opaque (Universal Opaque).

TopCEM Dual Cure Resin Cement is radiopaque, allowing for easy identification on radiographs. It belongs to Type 2 Class 3 dual cure materials in accordance with ISO 4049. The curing mechanism of the predicate devices and subject device is polymerization of uncured methacrylate ester monomers. This reaction is caused by photo initiator and chemical polymerization initiator systems.

6. Indications for Use

· Permanent cementation of all sorts of dental restorations including crowns, bridges, inlays/onlays, veneers and other restorations made from materials of metals/alloys, metal-ceramic, all-ceramic and/or porcelain, composites, and their combinations.

· Permanent cementation for all types of root canal posts.

· Core build-ups.

7. Summary of Physical and Chemical Properties Tests

The subject device belongs to Type 2 Class 3 dual cure materials in accordance with ISO 4049. The physical properties of the subject device were determined and tested according to ISO 4049, ISO 29022 and FDA guidance "Guidance for Industry and FDA Staff Dental Composite Resin Devices - Premarket Notification [510(k)]Submissions Document issued on: October 26, 2005". Bench testings were performed on the subject device and the predicate devices, the test results demonstrated the substantial equivalence when compared to the predicate devices.

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Summary of Physical and Chemical Properties Test
Items perISO 4049/ISO 29022	Pass/fail criteria	Conclusion
ISO 40495.2.2 Film thickness, lutingmaterials	The film thickness of luting materials in any event shall beno greater than 50 µm.	Satisfactory
ISO 40495.2.4 Working time, Class 1and Class 3 luting materials	The material shall be capable of forming a thin layer;during its formation there shall be no detectable change inits homogeneity, shall be not less than 60 s.	Satisfactory
ISO 40495.2.6 Setting time, Class 3materials	The setting time shall be not more than 10 min.	Satisfactory
ISO 40495.2.9 Flexural strength	The flexural strength shall be equal to or greater than 50MPa.	Satisfactory
ISO 40495.2.10 Water sorption andsolubility	The water sorption shall be ≤ 40 µg/mm³.The solubility of shall be ≤ 7.5 µg/mm³.	Satisfactory
ISO 40495.5 Radio-opacity	The radio-opacity shall be equal to or greater than that ofthe same thickness of aluminium (1 mm of material).	Satisfactory
Shear bond strength(The test methods refer to theISO 29022)	Meet internal standards.	Satisfactory
Bonding durability(The test methods refer to theISO 29022)	Meet internal standards.	Satisfactory
Compressive strengthFlexural strengthElastic modulus	Meet internal standards.	Satisfactory

8. Technological Characteristics Comparison

All components of the subject device are based upon industry well-known chemistry. The curing mechanism of the subject device and predicate devices are all of polymerization of uncured methacrylate ester monomers. The reaction is caused by photo initiator and chemical polymerization initiator systems. The following table shows the significant technological characteristics for the subject device and indicates the following similarities and differences with the predicate devices:

Technological Characteristics Comparison Table
TechnologicalCharacteristics	Subject device	Primary predicate	Secondary Predicate
Monomer matrix	K233082	K052820	K201790
Methacrylate based	Methacrylate based	Methacrylate based	Methacrylate based

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Technological Characteristics Comparison Table
TechnologicalCharacteristics	Subject device	Primary predicate	Secondary Predicate
	K233082	K052820	K201790
Primary Filler(s)	Silanated Barium glass filler	Silanated Barium glass filler	Silanated Barium glass filler
Physical Form	Pastes of Catalyst and Base	Pastes of Catalyst and Base	Pastes of Catalyst and Base
Indications of Use	• Permanent cementation ofall sorts of dentalrestorations includingcrowns, bridges,inlays/onlays, veneers andother restorations made frommaterials of metals/alloys,metal-ceramic, all-ceramicand/or porcelain,composites, and theircombinations.• Permanent cementation forall types of root canal posts.• Core build-ups.	ParaPost ParaCore automix5ml is indicated for corebuild-ups and cementationof posts.	Dual Cure Resin Cement is adental luting system designedfor cementation of all sorts ofdental restorations includingcrowns, bridges,inlays/onlays, veneers, dentalposts and other restorationsmade from materials ofmetals/alloys, metal-ceramic,all-ceramic and/or porcelain,composites, and theircombinations.
Prescription/over-the-counter use	Prescription	Prescription	Prescription
Curing method	Dual cure	Dual cure	Dual cure
Delivery form	Hand-mix / Automix	Automix	Hand-mix / Automix
RadiographicAppearance	Radiopaque	Radiopaque	Radiopaque
PhysicalProperties	The subject device and the predicate devices have substantially equivalent physicalproperties as they all conform to ISO 4049, ISO 29022 and FDA guidance "Guidance forIndustry and FDA Staff Dental Composite Resin Devices - Premarket Notification[510(k)] Submissions Document issued on: October 26, 2005".

The indications of the subject device are all covered by that of the 510(k) cleared predicate devices. Based on the indications for use in 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. The subject device has similar technological characteristics as the predicate devices. As compared to the primary predicate device, the subject device is also available in Hand-mix model, which is having the Catalyst and Base resin cement pastes packaged into physically separated single syringes instead of being packaged into a double barrel syringe as for the Automix. The base and catalyst are mixed in a 1:1 ratio to form dual-curing cement, and it will not pose any new issues of the safety and effectiveness. Therefore, the minor differences in the delivery system affect neither the intended use nor substantial equivalence.

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9. Summary of Biocompatibility

The subject device is substantially equivalent to the predicate devices that have been legally marketed for years and with no clinical adverse events. 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. The test items include Cytotoxicity, Sensitization, Irritation, Systemic Toxicity, Subchronic Toxicity and Genotoxicity.

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 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. 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.