Light Cure Dental Adhesive can be used as a strict self-etch dental bonding agent, or in combination with the traditional total etch or enamel etch procedures:

Direct bonding under a light-cured composite or compomer fillings/resin modified glass ionomer restoratives;
Repair of dental restorations of ceramic, composites and/or metal alloys;
Indirect dental restoration applications in combination with resin cement 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, mental-ceramic and/or porcelain, composites, and their combinations.

Device Description

Light Cure Dental Adhesive is a universal self-etch visible light curable dentine bonding agent specifically designed for meeting all your bonding needs. It is not only for direct bonding under a dental composite restorative or a resin modified glass ionomer cement restorative, but also for all indirect dental restoration applications, either used as a strict self-etch dental bonding agent, or in combination with the traditional total etch or enamel etch procedures. In all of those cases, this dental bonding agent will give you exceptional results and predicting a reliable treatment outcome.

AI/ML Overview

This document is a 510(k) summary for a Light Cure Dental Adhesive, which is a medical device. This type of submission is for establishing substantial equivalence to a predicate device, not for a clinical AI/ML study. Therefore, the questions related to AI/ML device performance, such as sample sizes for test sets, expert ground truth, MRMC studies, standalone performance, and training set details, are not applicable to this document.

However, I can extract the relevant information regarding the device's acceptance criteria and the studies performed to demonstrate its performance and substantial equivalence to a predicate device.

Acceptance Criteria and Device Performance for Light Cure Dental Adhesive (K201787)

This 510(k) submission establishes substantial equivalence for the Light Cure Dental Adhesive to a predicate device (DREAMBOND, K112118). The device is a dental bonding agent used in various dental restorative procedures.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria/Standard	Reported Device Performance (Light Cure Dental Adhesive)
Physical Properties	ISO 29022:2013 (Dentistry - Adhesive - Notched-edge sheer bond strength test)	Conforms to specifications of ISO 29022:2013 and internal final inspection standard. Substiantially equivalent physical property of shear bond strength to predicate device.
Biocompatibility	ISO 10993 standards (Cytotoxicity, Sensitization, Irritation, Systemic Toxicity, Subchronic Toxicity, Genotoxicity)	Performed fully following ISO 10993 standards and passed all tests.
Technological Characteristics	Similar method of polymerization, resin composition, solvent, method of application, prescription use, and etch method to predicate. Indications for Use are similar and fall within the intended use of the predicate device.	All evaluated technological characteristics (Method of polymerization, Resin composition, Solvent, Method of application, Indications of Use, Prescription/over-the-counter use, Etch Method) are either identical or substantially equivalent to the predicate device.

Summary of Studies that Prove the Device Meets Acceptance Criteria:

The device's performance and meeting of acceptance criteria were demonstrated through non-clinical testing, primarily focused on physical/chemical properties and biocompatibility.

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

Test Set Sample Size: Not explicitly stated as a numerical 'sample size' in the context of clinical data for AI/ML. For physical/chemical and biocompatibility testing, standard laboratory samples would have been used as per ISO guidelines, but specific numbers are not provided in this summary.
Data Provenance: The studies were conducted by Rizhao HuGe Biomaterials Company, Ltd. (China) and its contracted laboratories. The tests are non-clinical, laboratory-based.

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. This is a non-clinical submission. Ground truth, in this context, refers to scientific and regulatory standards (ISO standards) rather than expert clinical evaluation of an algorithm's output.

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

Not Applicable. This pertains to clinical evaluation or human-in-the-loop performance, which is not part of this 510(k) submission.

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. No MRMC study was conducted as this is not an AI/ML device.

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

Not Applicable. This is not an AI/ML device.

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

The "ground truth" for demonstrating substantial equivalence was based on internationally recognized testing standards (ISO 29022:2013 for physical properties and ISO 10993 for biocompatibility) and comparison to the technological characteristics and established safety/effectiveness of the legally marketed predicate device.

8. The sample size for the training set

Not Applicable. This is not an AI/ML device.

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

Not Applicable. This is not an AI/ML device.

Summary

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September 25, 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: K201787

Trade/Device Name: Light Cure Dental Adhesive Regulation Number: 21 CFR 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: Class II Product Code: KLE 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

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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 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-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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 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,

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

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Indications for Use

510(k) Number (if known) K201787

Device Name Light Cure Dental Adhesive

Indications for Use (Describe)

Light Cure Dental Adhesive can be used as a strict self-etch dental bonding agent, or in combination with the traditional total etch or enamel etch procedures:

Direct bonding under a light-cured composite or compomer fillings/resin modified glass ionomer restoratives;
Repair of dental restorations of ceramic, composites and/or metal alloys;
Indirect dental restoration applications in combination with resin cement 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, mental-ceramic and/or porcelain, composites, and their combinations.

Type of Use (Select one or both, as applicable)
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Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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K201787

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 25, 2020
1. 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	Mrs. Maggie Zheng
Contact Title	Regulatory Affairs Manager
E-mail	zhengxy@hugedent.com

3. Device Name

Trade name: Light Cure Dental Adhesive Common name: Dental Adhesive Classification name: Resin Tooth Bonding Agent (21 CFR 872.3200) Regulatory Class: II Product Code: KLE

4. Predicate Device Information

Table 1: Predicate Device Information
Owner/Operator	Device Trade Name	510 (k) No.	Product Code	Predicate
BISCO, INC.	DREAMBOND	K112118	KLE	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

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6. Indications for Use

Light Cure Dental Adhesive can be used as a strict self-etch dental bonding agent, or in combination with the traditional total etch or enamel etch procedures:

Direct bonding under a light-cured composite or compomer fillings/resin modified glass ionomer restoratives;
Repair of dental restorations of ceramic, composites and/or metal alloys;
Indirect dental restorations cementation applications in combination with resin cement 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, mental-ceramic, all-ceramic and/or porcelain, composites, and their combinations.

7. Summary of Physical and Chemical Properties Tests

Test standards and methods based on ISO 29022: 2013 (Dentistry - Adhesive - Notched-edge sheer bond strength test) and internal final inspection standard of Rizhao HuGe Biomaterials Company, Ltd.. And the results from testing demonstrate that Light Cure Dental Adhesive is substantially equivalent to the predicate device.

8. Technological Characteristics

All components of the subject device are based upon industry well-known chemistry. The etch methods of the subject device and predicate device covered the flexibility for total-, self- and selective-etch procedures. The following table shows the significant technological characteristics for the subject device and indicates the following similarities and differences with the predicate device:

Table 4: Technological Characteristics Comparison Table
TechnologicalCharacteristics	Subject device(Light Cure Dental Adhesive)	Primary predicateK112118

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Method ofpolymerization	Light Cured	Light Cured
Resincomposition	Unfilled, multifunctional methacrylate resin	Unfilled, multifunctional methacrylate resin
Solvent	Ethanol based	Ethanol based
Method ofapplication	Single component adhesive	Single component adhesive
Indications ofUse	Light Cure Dental Adhesive can be used as astrict self-etch dental bonding agent, or incombination with the traditional total etch orenamel etch procedures:- Direct bonding under a light-curedcomposite or compomer fillings/resinmodified glass ionomer restoratives;- Repair of dental restorations of ceramic,composites and/or metal alloys;- Indirect dental restorations cementationapplications in combination with resincement for cementation of all sorts of dentalrestorations including crowns, bridges,inlays/onlays, veneers, dental posts and otherrestorations made from materials ofmetals/alloys, mental-ceramic, all-ceramicand/or porcelain, composites, and theircombinations.	The indications of use of DREAMBONDare:1. all direct restorations2. all indirect restorations3. intra-oral repairs (i.e. repair. of any fixeddental prosthesis containing zirconia,alumina, metals, glass ceramics, toothstructure, and composites)4. desensitizing/sealing of tooth structure5. protective varnish for glass ionomerfillings6. priming of enamel for orthodontic use
Prescription/over-the-counter use	Prescription	Prescription
Etch Method	Total-etch, self-etch and selective-etchprocedures	Total-etch, self-etch and selective-etchprocedures
PhysicalProperties	The subject device and the predicate device have substantially equivalent physical propertyof shear bond strength as they all conform to the specifications set by internal finalinspection and the test method equal to ISO 29022:2013

9. Summary of Biocompatibility

The new device, Light Cure Dental Adhesive, 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 Light Cure Dental Adhesive (6mL) as the representative model in biocompatibility tests. Because our company only has one component formula for this product. The chemical compositions, raw material suppliers, curing method and other technological characteristic in all packing specifications are identical, the difference only depends on the quantity.

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The packaging bottle materials used for all packaging specifications are the same, and the packaging method is the same.

Therefore, the packaging specifications differences in the delivery system affect neither the intended use nor substantial equivalence.

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 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

§ 872.3200 Resin tooth bonding agent.

(a)
Identification. A resin tooth bonding agent is a device material, such as methylmethacrylate, intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration, such as a filling.(b)
Classification. Class II.