Dual Cure Resin Cement is a dental luting system designed for cementation of all sorts of dental restorations including crowns, bridges, inlays/onlays, veneers, dental posts and other restorations made from materials of metals/alloys, metal-ceramic, all-ceramic and/or porcelain, composites, and their combinations.

Device Description

Dual Cure Resin Cement is a versatile and ultimate dental dual cure (chemical and/or light cure) luting cement. This multi-purpose device is designed for cementation of all sorts of dental restorations made from materials of metal-ceramic, all-ceramic and/or porcelain, composites, and their combinations.

Dual Cure Resin Cement contains paste-paste of Base and Catalyst comprising primarily of dental methacrylate resins and inorganic fillers (with particle size range from about 0.01 - 3 microns and a filler volume of about 40%), inorganic pigments, photo-initiation and chemical curing systems. The mixing ratio, based on volume, is 1 part base paste : 1 part catalyst paste.

Dual Cure Resin Cement is delivered in either two seperated single syringe for Hand-mix and double-barrel syringes for Automix and comes in seven shades: TR (Translucent), A0 (Light+), A 1 (Light), A2 (Medium), A3 (Dark), White (White Opaque) and Opaque (Universal Opaque).

Dual Cure Resin Cement is radiopaque, allowing for easy identification on radiographs.

AI/ML Overview

The provided document is a 510(k) summary for a dental device, "Dual Cure Resin Cement." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving clinical effectiveness through extensive studies as might be required for a PMA (Premarket Approval) submission.

Therefore, many of the typical acceptance criteria and study details requested (e.g., sample size for test set, number of experts for ground truth, MRMC studies, standalone performance, training set details) are generally not applicable in this context. The acceptance criteria in this document relate to physical and chemical properties and comparison to a predicate device.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (from ISO standards)	Reported Device Performance	Conclusion
Film thickness of luting materials ≤ 50 µm (ISO 4049:2009, 5.2.2)	Satisfactory	Pass
Working time ≥ 60 s (ISO 4049:2009, 5.2.4)	Satisfactory	Pass
Setting time ≤ 10 min (ISO 4049:2009, 5.2.6)	Satisfactory	Pass
Flexural strength ≥ 50 MPa (ISO 4049:2009, 5.2.9)	Satisfactory	Pass
Water sorption ≤ 40 µg/mm³ (ISO 4049:2009, 5.2.10)	Satisfactory	Pass
Solubility ≤ 7.5 µg/mm³ (ISO 4049:2009, 5.2.10)	Satisfactory	Pass
Radio-opacity ≥ 1 mm of aluminum (ISO 4049:2009, 5.5)	Satisfactory	Pass
Shear bond strength for enamel and dentin ≥ 8 MPa (Internal standard, comparable to ISO 29022:2013)	Satisfactory	Pass
Biocompatibility (following ISO 10993 for Cytotoxicity, Sensitization, Irritation, Systemic Toxicity, Subchronic Toxicity and Genotoxicity)	Satisfactory	Pass

2. Sample size used for the test set and the data provenance

The document specifies "tests were performed fully following the ISO 10993 standards" for biocompatibility and specific ISO standards for physical and chemical properties (ISO 4049:2009 and ISO 29022:2013). However, it does not provide details on the specific sample sizes used for each of these tests.

Regarding data provenance, the testing was conducted by Rizhao HuGe Biomaterials Company, Ltd. There is no explicit mention of data provenance (e.g., country of origin, retrospective/prospective) for these lab-based material property tests, as they are typically conducted under controlled laboratory conditions, not on patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This device is a dental cement, and its performance is evaluated based on objective physical, chemical, and biological properties according to international standards (ISO). There is no "ground truth" established by human experts in the way that, for example, a diagnostic AI device would use expert interpretations of medical images. The "ground truth" here is derived from the standardized test methods and their defined pass/fail criteria.

4. Adjudication method for the test set

Not applicable. As the "ground truth" is determined by standardized laboratory measurements against defined criteria, no human adjudication method (like 2+1 or 3+1 consensus) is relevant for this type of device testing.

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 a dental cement, not a diagnostic imaging device or an AI-assisted device. Therefore, MRMC studies and AI assistance comparisons are irrelevant.

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

Not applicable. This is a dental cement, not an algorithm or AI-based device.

7. The type of ground truth used

The ground truth for this device is based on objective, standardized laboratory measurements of physical, chemical, and biological properties, as defined by international standards (ISO 4049:2009, ISO 29022:2013, and ISO 10993 series). The criteria are specific numerical values or qualitative outcomes (e.g., "Satisfactory").

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that requires a training set. The performance is based on the inherent material properties of the cement.

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

Not applicable. As there is no training set for this type of device, this question is not relevant.

Summary

{0}------------------------------------------------

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: a symbol on the left and the text "FDA U.S. FOOD & DRUG ADMINISTRATION" on the right. The symbol on the left is a stylized representation of the Department of Health & Human Services logo. The text on the right is in a blue sans-serif font, with "FDA" in a larger font size than the rest of the text.

September 29, 2020

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

Re: K201790

Trade/Device Name: Dual Cure Resin Cement Regulation Number: 21 CFR 872.3275 Regulation Name: Dental Cement Regulatory Class: Class II Product Code: EMA, EBF Dated: July 17, 2020 Received: July 27, 2020

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 (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.

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

{1}------------------------------------------------

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-reporting-

combination-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 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,

for Srinivas "Nandu" Nandkumar, Ph.D. Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K201790

Device Name Dual Cure Resin Cement

Indications for Use (Describe)

Dual Cure Resin Cement is a dental luting system designed for cementation of all sorts of dental restorations including crowns, bridges, inlays/onlays, veneers, dental posts and other restorations made from materials of metals/alloys, metalceramic, all-ceramic and/or porcelain, composites, and their combinations.

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)
\u2713

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the
time to review instructions, search existing data sources, gather and maintain the data needed and complete
and review the collection of information. Send comments regarding this burden estimate or any other aspect
of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services

Food and Drug Administration

Office of Chief Information Officer

Paperwork Reduction Act (PRA) Staff

PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB number."

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

{3}------------------------------------------------

K201790

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: September 29, 2020

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: Dual Cure Resin Cement Common name: Dual Cure Resin Cement Classification name: Dental Cement (21 CFR 872.3275) Regulatory Class: II Product Code: EMA, EBF

4. Predicate Device Information

Owner/Operator	Device Trade Name	510 (k) No.	Product Code	Predicate
IVOCLAR VIVADENT AG	Multilink Automix	K123397	EBF	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

{4}------------------------------------------------

Dual Cure Resin Cement is radiopaque, allowing for easy identification on radiographs.

6. Indications for Use

Dual Cure Resin Cement is a dental luting system designed for cementation of all sorts of dental restorations including crowns, bridges, inlays/onlays, veneers, dental posts and other restorations made from materials of metals/alloys, metal-ceramic and/or porcelain, composites, and their combinations.

7. Summary of Physical and Chemical Properties Tests

Dual Cure Resin Cement is classified as Type 2 Class 3 in accordance with ISO 4049, which belongs to luting materials that are cured by the application of external energy and also have a self-curing mechanism present ("dual cure" materials).

Test standards and methods based on ISO 4049:2009 and ISO 29022:2013:

ISO 4049: 2009 Dentistry - Polymer-Based Restorative Materials
ISO 29022:2013 Dentistry - Adhesive - Notched-edge shear bond strength test

Table 4: Summary of Physical and Chemical Properties Test
Items perISO 4049: 2009/ISO 29022:2013	Pass/fail criteria	Conclusion
ISO 4049: 20095.2.2 Film thickness, lutingmaterials	The film thickness of luting materials in any event shall beno greater than 50 µm.	Satisfactory

{5}------------------------------------------------

IHH

ISO 4049: 20095.2.4 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 4049: 20095.2.6 Setting time, Class 3materials	The setting time shall be not more than 10 min.	Satisfactory
ISO 4049: 20095.2.9 Flexural strength	The flexural strength shall be equal to or greater than 50MPa.	Satisfactory
ISO 4049: 20095.2.10 Water sorption andsolubility	The water sorption shall be ≤ 40 µg/mm3.The solubility of shall be ≤ 7.5 µg/mm3.	Satisfactory
ISO 4049: 20095.5 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 method equal to theISO 29022:2013)	Shear bond strength for enamel and dentin≥8 MPa(Internal standard)	Satisfactory

8. Technological Characteristics

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:

Table 5: Technological Characteristics Comparison Table
TechnologicalCharacteristics	Subject device(Dual Cure Resin Cement)	Primary predicate
Monomer matrix	Methacrylate based	Methacrylate based
Primary Filler(s)	Silanated Barium glass filler	Silanated Barium glass filler
Physical Form	Pastes of Catalyst and Base	Pastes of Catalyst and Base
Indications of Use	Dual Cure Resin Cement is a dental lutingsystem designed for cementation of allsorts of dental restorations includingcrowns, bridges, inlays/onlays, veneers,dental posts and other restorations madefrom materials of metals/alloys,metal-ceramic, all-ceramic and/orporcelain, composites, and theircombinations.	Multilink Automix is used for the permanentcementation of indirect restorations where astrong bond us desired:- Inlays, onlays, crowns, bridges and rootposts made of:● Metal and metal ceramics● All-ceramics, in particular opaquezirconium oxide ceramics● Composites and fiber-reinforcedcomposites
Prescription/over-the-counter use	Prescription	Prescription

{6}------------------------------------------------

Table 5: Technological Characteristics Comparison Table
TechnologicalCharacteristics	Subject device(Dual Cure Resin Cement)	Primary predicate
Curing method	Dual cure	Dual cure
Delivery form	Hand-mix / Automix	Automix
RadiographicAppearance	Radiopaque	Radiopaque
Physical Properties	The subject device and the predicate devices have substantially equivalent physicalproperties as they all conform to the specifications set by ISO 4049 and ISO 29022.

The subject device has the same technological characteristics as the predicate devices with the exception of the additional hand-mixing option. As compared to the predicated devices, the subject device is also available in Hand-mix, 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. Regardless of which mode of operation by Hand-mix or 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.

9. Summary of Biocompatibility

The new device, Dual Cure Resin Cement, 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.

We selected our Dual Cure Resin Cement [Hand-mix, shade: Opague (Universal Opaque)] as the representative model in biocompatibility tests because it is the worst case scenario. In addition, the Hand-mix and Automix of our Dual Cure Resin Cement have the same chemical compositions, raw material suppliers, curing method and other technological characteristic.

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. Conclusions

Based on the indications for use, technological characteristics, performance testing and

{7}------------------------------------------------

HUGE

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

§ 872.3275 Dental cement.

(a)
Zinc oxide-eugenol —(1)Identification. Zinc oxide-eugenol is a device composed of zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.(b)
Dental cement other than zinc oxide-eugenol —(1)Identification. Dental cement other than zinc oxide-eugenol is a device composed of various materials other than zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class II.