Bright Bond Universal

K200153 · Genoss Co., Ltd. · KLE · Oct 28, 2020 · Dental

Device Facts

• Record ID: K200153
• Device Name: Bright Bond Universal
• Applicant: Genoss Co., Ltd.
• Product Code: KLE · Dental
• Decision Date: Oct 28, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3200
• Device Class: Class 2

Intended Use

1) Direct bonding for light-cured composites to tooth surface 2) Bonding of dual-cured core build up composites to tooth surface 3) Intraoral repair of composite, PFM and ceramic restoration using cements 4) Sealing of tooth preparation for indirect restoration

Device Story

Bright Bond Universal is a light-cured dental adhesive; combines etching, priming, and bonding functions in a single-bottle liquid solution. Used by dental professionals in clinical settings to facilitate bonding between dentin/enamel and restorative materials. Applied directly to tooth surfaces; light-cured to achieve polymerization. Provides strong, durable bonds for direct and indirect restorations; seals tooth preparations. Benefits include simplified clinical workflow and improved restoration retention.

Clinical Evidence

Bench testing only. No clinical data provided. Performance evaluated via ISO 10993 biocompatibility testing (cytotoxicity, irritation, sensitization, systemic toxicity, genotoxicity, implantation, chronic toxicity) and ISO 4049/ISO 29022 bench testing (film thickness, depth of cure, bonding strength). Results: film thickness 2.0 µm (≤50 µm limit), depth of cure 3.0 mm (≥1.5 mm limit), dentin bonding strength 16 MPa (≥8 MPa limit), enamel bonding strength 14 MPa (≥8 MPa limit).

Technological Characteristics

Single-bottle liquid dental adhesive. Composition: Multifunctional methacrylate resins (HEMA, 10-MDP). Non-sterile. Shelf-life: 2 years. Performance specs: pH 2.1, film thickness 2.0 µm, depth of cure 3.0 mm. Complies with ISO 4049:2009 and ISO 29022:2013 standards.

Indications for Use

Indicated for dental patients requiring direct bonding of light-cured composites, bonding of dual-cured core build-up composites, intraoral repair of composite, PFM, and ceramic restorations, and sealing of tooth preparations for indirect restorations.

Regulatory Classification

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.

Predicate Devices

• Scotchbond Universal (K110302)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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
- 2) Bonding of dual-cured core build up composites to tooth surface
- 3) Intraoral repair of composite, PFM and ceramic restoration using cements
- 4) 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, 105<br>Gwanggyo-ro, Yeongtong-gu, Suwon-si, Gyeonggi-do, Korea |
| Phone/Fax | [phone]/ [phone] |
| Contact person | HongJun Jeon / RA<br>[e-mail] |
| 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

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.

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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
- 2) Bonding of dual-cured core build up composites to tooth surface
- 3) Intraoral repair of composite, PFM and ceramic restoration using cements
- 4) 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<br>(Dentin, Enamel) | Human tooth<br>(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<br>(HEMA, 10-MDP) | Multifunctional methacrylate resins<br>(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-cured<br>composites to tooth surface<br>2) Bonding of dual-cured core build<br>up composites to tooth surface | 1) Bonding light-cured composite or<br>compomer for all classes of direct<br>restorations<br>2) Bonding of dual-cure cements and<br>core build-up materials<br>3) 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 amalgam<br>restorations | |
|------------------|-------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|--|
| | 4) Sealing of tooth preparation for<br>indirect restoration | 6) Protective varnish for glass ionomer<br>restorative materials<br>7) Repair of composite or compomer<br>restorations<br>8) Bonding sealants | |
| | | 9) Bonding veneers in combination<br>with 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-<br>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 and<br>No specific changes | No impurities and<br>No specific changes | CDM-18-0161-<br>01 |
| 2 | Capacity test | Weight difference | Capacity error of;<br>Standard Capacity<br>$\u00b1 5 %$ | 2.75 % | CDM-18-0161-<br>02 |
| 3 | Package test | Bare eyes | No damage | No damages, cracks | CDM-18-0161-<br>03 |
| 4 | Film Thickness | ISO 4049:2009<br>7.5 | $\u2264 50 \u00b5m$ | $2 \u00b5m$ | CDM-18-0161-<br>04 |
| 5 | Sensitivity to<br>Ambient Light | ISO 4049:2009<br>7.9 | Must be physically<br>uniform | Homogeneous | CDM-18-0161-<br>05 |
| 6 | Depth of Cure | ISO 4049:2009<br>7.10 | $\u2265 1.5 mm$ | 3.0 mm | CDM-18-0161-<br>06 |
| 7 | Bonding<br>Strength<br>(Dentin) | ISO 29022:2013<br>7 | $\u2265 8 MPa$ | 16 MPa | CDM-18-0161-<br>09 |
| 8 | Bonding<br>Strength<br>(Enamel) | ISO 29022:2013<br>7 | $\u2265 8 MPa$ | 14 MPa | CDM-18-0161-<br>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.