1. all direct restorations
1. all indirect restorations
1. intra-oral repairs (i.e. repair of any fixed dental prosthesis containing zirconia, alumina, metals, glass ceramics, tooth structure, and composites)
1. desensitizing/sealing of tooth structure
1. protective varnish for glass ionomer fillings
1. priming of enamel for orthodontic use

Device Description

The Hi-Bond Universal is a light-curing dentin adhesive system composed of several resin monomers, inorganic fillers, polymerization-related initiators and accelerators, ethyl alcohol, and antioxidants. The Hi-Bond Universal is a light-curing type dental adhesive offering etching. priming, and bonding at once. The Hi-Bond Universal is packaged in a bottle made of polyethylene and polypropylene, and then packaged in a box.

AI/ML Overview

The document provided is a 510(k) Premarket Notification from the FDA for a dental bonding agent named "Hi-Bond Universal." It primarily focuses on demonstrating substantial equivalence to a predicate device ("All-Bond Universal w/ BAC") rather than providing a detailed report of a study designed to meet specific acceptance criteria for a new AI/software device.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for an AI/software device cannot be extracted from this document, as it pertains to a traditional medical device (dental adhesive) and not an AI-powered one.

However, I can provide the "Performance Data (Non-Clinical)" which lists the types of tests performed on the device to support its substantial equivalence. This section serves as the closest equivalent to "acceptance criteria and reported device performance" for this specific product.

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

The document lists the following non-clinical performance tests that were performed to support substantial equivalence. While it doesn't explicitly state "acceptance criteria" and "reported device performance" in a quantitative table for all tests, it implies that the results of these tests met the necessary standards to demonstrate equivalence to the predicate device.

Test Performed	Implied/Reported Performance
Appearance	Acceptable
Volume Accuracy	Acceptable
Packing	Acceptable
Film Thickness in accordance with ISO 4049	12 µm
Sensitivity to ambient light in accordance with ISO 4049	Acceptable
Polymerization depth in accordance with ISO 4049	Acceptable
Adhesive strength (Dentin, self-etch) in accordance with ISO 11405	Acceptable
Adhesive strength (Enamel, total-etch) in accordance with ISO 11405	Acceptable
pH	Acceptable
Dentinal tubule blockage	Acceptable

Note: For "Film Thickness," a specific value (12 µm) is reported for the subject device. The predicate device's film thickness is listed as 3.4 µm. The document states that the "difference is in chemical compositions; however, the test results of biocompatibility and performance tests supports that the subject device is substantially equivalent to the predicate device." This suggests that despite the difference in this particular metric, it was deemed acceptable within the context of substantial equivalence. For other tests where no specific measurement is given, "Acceptable" is inferred because the conclusion states that the test results support substantial equivalence.

Regarding the remaining requested information (2-9):

The provided document does not contain any of the following information:

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): The document does not describe a "test set" in the context of an AI/software device. The performance tests are for a physical dental material.
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, as the device is not an AI/software device requiring expert adjudicated ground truth.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable. The "ground truth" for this device would be defined by standard material testing protocols and physical/chemical properties, not clinical outcomes or expert labels in the way asked for an AI device.
The sample size for the training set: Not applicable. This is not an AI/machine learning device.
How the ground truth for the training set was established: Not applicable.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: on the left, there is a symbol representing the Department of Health & Human Services, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The text is arranged in two lines, with "FDA" being larger and bolder than the rest of the text.

May 22, 2023

Mediclus Co., LTD. % Priscilla Chung Regulatory Affairs Consultant LK Consulting Group USA, Inc. 18881 Von Karman Ave Ste 160 Irvine, California 92612

Re: K230465

Trade/Device Name: Hi-Bond Universal Regulation Number: 21 CFR 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: Class II Product Code: KLE, EBF, LBH Dated: February 21, 2023 Received: February 21, 2023

Dear Priscilla Chung:

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

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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 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 (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 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,

Michael E. Adjodha -5

Michael E. Adjodha, M.ChE. 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 Page 2

Enclosure

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Indications for Use

510(k) Number (if known) K230465

Device Name Hi-Bond Universal

Indications for Use (Describe)

1. all direct restorations
1. all indirect restorations
1. intra-oral repairs (i.e. repair of any fixed dental prosthesis containing zirconia, alumina, metals, glass ceramics, tooth structure, and composites)
1. desensitizing/sealing of tooth structure
1. protective varnish for glass ionomer fillings
1. priming of enamel for orthodontic use

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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K230465 - 510(k) Summary

This summary of 510(k)-safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.

Feb 21, 2023 Date: Date: Date: Date: Date: Date: Date: Date: Date: Date: Date: Date: Date: Date: Date: Date: Date: Date: Date: Date: Date: Date: Date: Date: Date: Date: Date: Date: Date:

1. Applicant / Submitter:

MEDICLUS CO., LTD. No. 1210, 134 Gongdan-ro, Heungdeok-gu, Cheongju-si, Chungcheongbuk-do, Republic of Korea Tel : +82-43-211-2877 Fax : +82-43-211-2866

Submission Correspondent: 2.

Priscilla Chung LK Consulting Group USA, Inc. 18881 Von Karman Ave STE 160 Irvine CA 92620 Phone: 714-202-5789 Fax: 714-409-3357 Email: juhee.c(@lkconsultinggroup.com

3. Device:

Proprietary Name:	Hi-Bond Universal
Common Name:	Dental adhesive material
Classification Name:	Agent, Tooth Bonding, Resin
Classification:	Class II, 21 CFR 872.3200
Classification Product Code:	KLE

PrimaryPredicate Device: 4.

All-Bond Universal w/ BAC (K161051) by Bisco, Inc.

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5. Device Description:

6. Indications for Use:

1. all direct restorations
1. all indirect restorations
1. intra-oral repairs (i.e. repair of any fixed dental prosthesis containing zirconia, alumina, metals, glass ceramics, tooth structure, and composites)
1. desensitizing/sealing of tooth structure
1. protective varnish for glass ionomer fillings
1. priming of enamel for orthodontic use

7. Performance Data (Non-Clinical):

The following tests were performed on the subject device and the test results support that the subject device is substantially equivalent to the predicate devices.

Appearance
Volume Accuracy
Packing
Film Thickness in accordance with ISO 4049 ■
Sensitivity to ambient light in accordance with ISO 4049
Polymerization depth in accordance with ISO 4049
Adhesive strength (Dentin, self-etch) in accordance with ISO 11405
Adhesive strength (Enamel, total-etch) in accordance with ISO 11405
pH
Dentinal tubule blockage

8. Substantial Equivalence

8.1. Comparison Chart

	Subject Device	Predicate Device
510(K) Number	-	K161051
Device Name	Hi-Bond Universal	All-Bond Universal w/ BAC
Manufacturer	MEDICLUS CO., LTD.	Bisco, Inc.
Product Code	KLE	KLE

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Design	Image: Hi-Bond bottle	Image: All-Bond Universal bottle
Indications for Use	1. all direct restorations2. all indirect restorations3. intra-oral repairs (i.e. repair of anyfixed dental prosthesis containingzirconia, alumina, metals, glassceramics, toothstructure, and composites)4. desensitizing/sealing of toothstructure5. protective varnish for glass ionomerfillings6. priming of enamel for orthodontic use	1. all direct restorations2. all indirect restorations3. intra-oral repairs (i.e. repair of anyfixed dental prosthesis containingzirconia, alumina, metals, glass ceramics,toothstructure, and composites)4. desensitizing/sealing of tooth structure5. protective varnish for glass ionomerfillings6. priming of enamel for orthodontic use
Method ofpolymerization	Light Cured	Light Cured
Material Composition	- 10-Methacryloyl-oxydecyldihydrogen phosphate- 2-Hydroxyethyl methacrylate- Bisphenol A glycerolateDimethacrylate- Water- Ethanol- Ethyl 4-dimethylaminobenzoate	- 10-Methacryloyl-oxydecyldihydrogen phosphate- 2-Hydroxyethyl methacrylate- Bisphenol A diglycidylmethacrylate- Water- Ethanol
Method of application	Single component adhesive	Single component adhesive
Physical /MechanicalPropertyComparison	FilmthicknessEtchMethods	12μm	3.4μm
		Self-etch and total-etch	Self-etch and total-etch

8.2. Substantial Equivalence Discussion

The subject device has the same indications for use statement as well as technological characteristics as the predicate device (K161051, All-Bond Universal w/ BAC). Both devices are a single component system offering self-etching and total etching. The difference is in chemical compositions; however, the test results of biocompatibility and performance tests supports that the subject device is substantially equivalent to the predicate device.

9. Conclusion:

Based on the information submitted herein, MEDICLUS CO., LTD. concludes that the Hi-Bond Universal is substantially equivalent to the predicate device.

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.