Bright Bond Universal is a light-cured dental adhesive that combines etching, priming, and bonding functions in a single bottle solution. It provides strong and durable bonds between dentin/enamel and light-curable direct/indirect restorative materials.

AI/ML Overview

The provided text describes the acceptance criteria and performance data for a dental bonding agent, "Bright Bond Universal," in the context of its 510(k) premarket notification to the FDA. The study presented here is a bench testing study, not a clinical study involving human patients or multi-reader studies. Therefore, many of the requested details about human expert involvement, MRMC studies, and patient data provenance are not applicable to the information contained in this document.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The device's performance was evaluated against a set of physical and chemical specifications for a dental bonding agent and biocompatibility standards.

No.	Test	Method	Acceptance Criteria	Reported Device Performance	Pass/Fail
1	Cytotoxicity	ISO 10993-5	None cytotoxicity	-	Pass
2	Irritation	ISO 10993-10	None oral irritation	-	Pass
3	Sensitization	ISO 10993-10	None sensitization	-	Pass
4	Acute systemic toxicity	ISO 10993-11	None systemic toxicity	-	Pass
5	Genotoxicity	ISO 10993-3	None genotoxicity	-	Pass
6	Implantation	ISO 10993-6	Biocompatible	-	Pass
7	Chronic toxicity	ISO 10993-11	No chronic toxicity	-	Pass
1	Visual test	Bare eyes	No impurities and No specific changes	No impurities and No specific changes	-
2	Capacity test	Weight difference	Capacity error of; Standard Capacity ± 5 %	2.75 %	-
3	Package test	Bare eyes	No damage	No damages, cracks	-
4	Film Thickness	ISO 4049:2009 7.5	≤ 50 µm	2 µm	-
5	Sensitivity to Ambient Light	ISO 4049:2009 7.9	Must be physically uniform	Homogeneous	-
6	Depth of Cure	ISO 4049:2009 7.10	≥ 1.5 mm	3.0 mm	-
7	Bonding Strength (Dentin)	ISO 29022:2013 7	≥ 8 MPa	16 MPa	-
8	Bonding Strength (Enamel)	ISO 29022:2013 7	≥ 8 MPa	14 MPa	-

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: The document does not specify exact sample sizes for each bench test. However, these tests are typically conducted on a sufficient number of material samples to ensure statistical validity for the specific test (e.g., multiple specimens for bonding strength, multiple replicates for biocompatibility assays).
Data Provenance: The tests were conducted by GENOSS Co., Ltd. (South Korea). The data is from laboratory bench testing of the physical properties and biocompatibility of the bonding agent. It is inherently "prospective" in the sense that the tests were specifically performed to demonstrate the device's characteristics for regulatory submission. It does not involve patient data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable. The "ground truth" for these tests is established by industry-standardized test methods (e.g., ISO standards) and measurable physical/chemical properties, not by human expert opinion or interpretation of images. The results are quantitative measurements.

4. Adjudication Method for the Test Set

This is not applicable. The tests involve objective measurements (e.g., weight difference, film thickness, bonding strength in MPa, observation of cell viability or tissue reaction), rather than subjective interpretations requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC study was not done. This type of study is relevant for AI/radiology devices where human readers interpret medical images. This document describes a dental material, not an imaging device or an AI algorithm for image interpretation.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This is not applicable. This is not an AI algorithm. The performance described is the inherent performance of the dental bonding material itself.

7. The Type of Ground Truth Used

The ground truth used for these tests is based on:

Standardized Test Methods: Specific ISO standards (e.g., ISO 10993 for biocompatibility, ISO 4049 and ISO 29022 for physical properties) define how the tests are performed and how results are interpreted.
Quantitative Measurements: Performance is measured against predetermined quantifiable thresholds (e.g., MPa for bonding strength, µm for film thickness, visual assessment of impurities).
Biocompatibility Endpoints: For biocompatibility, the ground truth is established by the absence of adverse biological responses as defined by the ISO 10993 series of standards.

8. The Sample Size for the Training Set

This is not applicable. There is no "training set" as this is not an AI/machine learning model. The device's formulation and manufacturing processes are likely developed through research and development, but there isn't a "training set" of data in the AI sense.

9. How the Ground Truth for the Training Set Was Established

This is not applicable, as there is no training set.

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). 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.

October 28, 2020

GENOSS Co., Ltd. Hong Jeon Manager 1F, Gyeonggi R&DB Center, 105 Gwanggyo-ro, Yeongtong-gu, Suwon-si Suwon-si. Gyeonggi-do 16229 SOUTH KOREA

Re: K200153

Trade/Device Name: Bright Bond Universal Regulation Number: 21 CFR 872.3200 Regulation Name: Resin tooth bonding agent Regulatory Class: Class II Product Code: KLE Dated: August 3, 2020 Received: August 3, 2020

Dear Hong Jeon:

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 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

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Image /page/2/Picture/0 description: The image shows the logo for GENOSS. The word "GENOSS" is written in a sans-serif font, with the first three letters in a dark green color and the last three letters in a lighter green color. The letters are connected to each other, and the logo has a modern and clean look.

Indication for use

K200153 510(k) Number:

Device Name: Bright Bond Universal

Indication for use:

1. Direct bonding for light-cured composites to tooth surface
1. Bonding of dual-cured core build up composites to tooth surface
1. Intraoral repair of composite, PFM and ceramic restoration using cements
1. Sealing of tooth preparation for indirect restoration

Prescription Use __ √________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)

AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Image /page/3/Picture/0 description: The image shows the logo for GENOSS. The word "GENOSS" is written in a sans-serif font. The letters "GEN" are in a dark green color, while the letters "OSS" are in a lighter green color. The logo has a modern and clean design.

510(k) Summary K200153

12/20/2019

1. Company

	Submitter
Name	GENOSS Co., Ltd.
Address	1F, Gyeonggi R&DB Center / 226, 2F, GSBC, 105Gwanggyo-ro, Yeongtong-gu, Suwon-si, Gyeonggi-do, Korea
Phone/Fax	+82-70-7098-7541/ +82-31-888-5105
Contact person	HongJun Jeon / RAhjjeon@genoss.com
Summary Date	12/20/2019

2. Device Name

Proprietary name: Bright Bond Universal Regulation description : Resin tooth bonding agent Classification name: Agent, Tooth Bonding, Resin

3. Predicate Device

K110302 Scotchbond Universal

4. Description

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Image /page/4/Picture/0 description: The image shows the word "GENOSS" in a stylized font. The first four letters, "GENO", are in a dark green color, while the last three letters, "OSS", are in a lighter green color. The letters are connected to each other, and the overall design is modern and sleek.

5. Indication for use

1. Direct bonding for light-cured composites to tooth surface
1. Bonding of dual-cured core build up composites to tooth surface
1. Intraoral repair of composite, PFM and ceramic restoration using cements
1. Sealing of tooth preparation for indirect restoration

6. Technological Characteristics

Bright Bond Universal has the similar technological characteristics as the predicate device; main material, indication for use and design. Technological characteristics of Bright Bond Universal, Scotchbond Universal are as following

Device name		Bright Bond Universal	Scotchbond Universal
Manufacturer		Genoss Co., Ltd.	3M ESPE
510(k) Number		New Device	K110302
Target population		Human tooth(Dentin, Enamel)	Human tooth(Dentin, Enamel)
Purpose	Clinical	Restoration	Restoration
Site of application		Dentin, Enamel	Dentin, Enamel
Clinical Performance		Strong bonding with composite resin	Strong bonding with composite resin
Materials	Biological	Multifunctional methacrylate resins(HEMA, 10-MDP)	Multifunctional methacrylate resins(HEMA, 10-MDP)
Chemical Safety		Biocompatible	Biocompatible
Sterilization		Non-sterile	Non-sterile
Shelf-Life		2 years	2 years
Form	Technical	Liquid	Liquid
Indication for use		1) Direct bonding for light-curedcomposites to tooth surface2) Bonding of dual-cured core buildup composites to tooth surface	1) Bonding light-cured composite orcompomer for all classes of directrestorations2) Bonding of dual-cure cements andcore build-up materials3) Bonding of self-cure composites

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Image /page/5/Picture/0 description: The image shows the logo for GENOSS. The logo is written in a sans-serif font, with the letters "GENO" in a dark green color and the letters "SS" in a lighter green color. The logo is simple and modern, and the colors are eye-catching.

	and ceramic restoration using cements	5) Sealing of dentin prior to amalgamrestorations
	4) Sealing of tooth preparation forindirect restoration	6) Protective varnish for glass ionomerrestorative materials7) Repair of composite or compomerrestorations8) Bonding sealants
		9) Bonding veneers in combinationwith 3MTM RelyXTM Veneer Cement
Use	Prescription	Prescription
pH	2.1	2.7
Film thickness	2.0 µm	10.6 µm
Depth of cure	3.0 mm	2.8 mm
Bonding Strength	24.5 Mpa	22.0 MPa

7. Performance Data

Biocompatibility testing on the proposed Bright Bond Universal has been completed. Requirements for biological evaluation of the proposed device were based on FDA recognized concensus standard of ISO10993, "Biological Evaluation of Medical Devices, Part 1: Evaluation and Testing." The biocompatibility test results show that the materials used in the design and manufacture of the components of the proposed device are non-toxic and nonsensitizing to biological bone and tissues with its intended use. The following biocompatibility tests were completed:

(P: Pass, F: Fail)

No.	Test	Method	Acceptance criteria	P/F	Report No.
1	Cytotoxicity	ISO 10993-5	None cytotoxicity	P	CDM-18-0161-11
2	Irritation	ISO 10993-10	None oral irritation	P	CDM-18-0161-12
3	Sensitization	ISO 10993-10	None sensitization	P	MTK-2019-000014
4	Acute systemic toxicity	ISO 10993-11	None systemic toxicity	P	CDM-18-0161-13

510(k) Summary

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Image /page/6/Picture/0 description: The image shows the word "GENOSS" in a stylized font. The first three letters, "GEN", are in a dark green color, while the last three letters, "OSS", are in a lighter green color. The font is sans-serif and has a modern, slightly rounded appearance. The letters are connected to each other, creating a sense of unity and flow.

5	Genotoxocity	ISO 10993-3	None genotoxicity	P	BER-18-056
6	Implantation	ISO 10993-6	Biocompatible	P	BER-18-056
7	Chronic toxicity	ISO 10993-11	No chronic toxicity	P	BER-18-056

The proposed Bright Bond Universal was evaluated using the following performance bench testing to confirm the performance characteristics:

No.	Items	Method	Acceptance Criteria	Result	File No.
1	Visual test	Bare eyes	No impurities andNo specific changes	No impurities andNo specific changes	CDM-18-0161-01
2	Capacity test	Weight difference	Capacity error of;Standard Capacity$\u00b1 5 %$	2.75 %	CDM-18-0161-02
3	Package test	Bare eyes	No damage	No damages, cracks	CDM-18-0161-03
4	Film Thickness	ISO 4049:20097.5	$\u2264 50 \u00b5m$	$2 \u00b5m$	CDM-18-0161-04
5	Sensitivity toAmbient Light	ISO 4049:20097.9	Must be physicallyuniform	Homogeneous	CDM-18-0161-05
6	Depth of Cure	ISO 4049:20097.10	$\u2265 1.5 mm$	3.0 mm	CDM-18-0161-06
7	BondingStrength(Dentin)	ISO 29022:20137	$\u2265 8 MPa$	16 MPa	CDM-18-0161-09
8	BondingStrength(Enamel)	ISO 29022:20137	$\u2265 8 MPa$	14 MPa	CDM-18-0161-10

All test results demonstrate that the materials chosen, the manufacturing process, and the design utilized for the Bright Bond Universal met the established specifications necessary for consistent performance according to its intended use.

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Image /page/7/Picture/0 description: The image shows the word "GENOSS" in a stylized font. The first three letters, "GEN", are in a dark green color, while the last three letters, "OSS", are in a lighter, lime green color. The letters are bold and slightly slanted, giving the word a dynamic appearance. The logo appears to be for a company or organization named "GENOSS".

8. Conclusion

Based on the information provided in this premarket notification of GENOSS Co., Ltd. Concludes that Bright Bond Universal is acceptable and safe, substantially equivalent to predicate devices.

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.