K Number
K200153
Device Name
Bright Bond Universal
Manufacturer
Date Cleared
2020-10-28

(280 days)

Product Code
Regulation Number
872.3200
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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 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.
More Information

Not Found

No
The device description and performance studies focus on the chemical and physical properties of a dental adhesive, with no mention of AI or ML.

No.
The device is a bonding agent used to attach restorative materials to teeth, not to treat or cure a disease or condition.

No

This device is a dental adhesive used for bonding restoratives to tooth surfaces, not for diagnosing medical conditions.

No

The device description clearly states it is a "light-cured dental adhesive" and describes physical properties like film thickness and bonding strength, indicating it is a physical material, not software.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use/Indications for Use: The intended uses are all related to direct application and bonding of materials to the tooth surface for restorative purposes. This is a direct treatment application, not a diagnostic test performed on a sample taken from the body.
  • Device Description: The description clearly states it's a "light-cured dental adhesive" used for bonding between tooth structure and restorative materials. This aligns with a therapeutic or restorative device, not a diagnostic one.
  • Anatomical Site: The device is applied directly to the human tooth (dentin and enamel). IVDs typically analyze samples (blood, urine, tissue, etc.) taken from the body.
  • Performance Studies and Key Metrics: The performance studies focus on biocompatibility and physical properties related to bonding strength and material characteristics (film thickness, depth of cure). These are relevant to the performance of a dental adhesive, not the accuracy of a diagnostic test.
  • Predicate Device: The predicate device, Scotchbond Universal, is also a dental adhesive, further supporting the classification as a dental restorative device.

IVDs are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not perform any such analysis on a specimen.

N/A

Intended Use / Indications 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

Product codes (comma separated list FDA assigned to the subject device)

KLE

Device 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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Human tooth (Dentin, Enamel)

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Prescription Use

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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:

  1. Cytotoxicity, Method: ISO 10993-5, Acceptance criteria: None cytotoxicity, Result: P
  2. Irritation, Method: ISO 10993-10, Acceptance criteria: None oral irritation, Result: P
  3. Sensitization, Method: ISO 10993-10, Acceptance criteria: None sensitization, Result: P
  4. Acute systemic toxicity, Method: ISO 10993-11, Acceptance criteria: None systemic toxicity, Result: P
  5. Genotoxicity, Method: ISO 10993-3, Acceptance criteria: None genotoxicity, Result: P
  6. Implantation, Method: ISO 10993-6, Acceptance criteria: Biocompatible, Result: P
  7. Chronic toxicity, Method: ISO 10993-11, Acceptance criteria: No chronic toxicity, Result: P

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

  1. Visual test, Method: Bare eyes, Acceptance Criteria: No impurities and No specific changes, Result: No impurities and No specific changes
  2. Capacity test, Method: Weight difference, Acceptance Criteria: Capacity error of; Standard Capacity +/- 5 %, Result: 2.75 %
  3. Package test, Method: Bare eyes, Acceptance Criteria: No damage, Result: No damages, cracks
  4. Film Thickness, Method: ISO 4049:2009 7.5, Acceptance Criteria: = 1.5 mm, Result: 3.0 mm
  5. Bonding Strength (Dentin), Method: ISO 29022:2013 7, Acceptance Criteria: >= 8 MPa, Result: 16 MPa
  6. Bonding Strength (Enamel), Method: ISO 29022:2013 7, Acceptance Criteria: >= 8 MPa, Result: 14 MPa

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K110302

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 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.

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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

1

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
NameGENOSS Co., Ltd.
Address1F, Gyeonggi R&DB Center / 226, 2F, GSBC, 105
Gwanggyo-ro, Yeongtong-gu, Suwon-si, Gyeonggi-do, Korea
Phone/Fax+82-70-7098-7541/ +82-31-888-5105
Contact personHongJun Jeon / RA
hjjeon@genoss.com
Summary Date12/20/2019

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
    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 nameBright Bond UniversalScotchbond Universal
ManufacturerGenoss Co., Ltd.3M ESPE
510(k) NumberNew DeviceK110302
Target populationHuman tooth
(Dentin, Enamel)Human tooth
(Dentin, Enamel)
PurposeClinicalRestorationRestoration
Site of applicationDentin, EnamelDentin, Enamel
Clinical PerformanceStrong bonding with composite resinStrong bonding with composite resin
MaterialsBiologicalMultifunctional methacrylate resins
(HEMA, 10-MDP)Multifunctional methacrylate resins
(HEMA, 10-MDP)
Chemical SafetyBiocompatibleBiocompatible
SterilizationNon-sterileNon-sterile
Shelf-Life2 years2 years
FormTechnicalLiquidLiquid
Indication for use1) Direct bonding for light-cured
composites to tooth surface
  1. Bonding of dual-cured core build
    up composites to tooth surface | 1) Bonding light-cured composite or
    compomer for all classes of direct
    restorations
  2. Bonding of dual-cure cements and
    core build-up materials
  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
restorations | |
|------------------|-------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|--|
| | 4) Sealing of tooth preparation for
indirect restoration | 6) Protective varnish for glass ionomer
restorative materials
7) Repair of composite or compomer
restorations
8) Bonding sealants | |
| | | 9) Bonding veneers in combination
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.TestMethodAcceptance criteriaP/FReport No.
1CytotoxicityISO 10993-5None cytotoxicityPCDM-18-0161-11
2IrritationISO 10993-10None oral irritationPCDM-18-0161-12
3SensitizationISO 10993-10None sensitizationPMTK-2019-
000014
4Acute systemic toxicityISO 10993-11None systemic toxicityPCDM-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.

5GenotoxocityISO 10993-3None genotoxicityPBER-18-056
6ImplantationISO 10993-6BiocompatiblePBER-18-056
7Chronic toxicityISO 10993-11No chronic toxicityPBER-18-056

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

No.ItemsMethodAcceptance CriteriaResultFile No.
1Visual testBare eyesNo impurities and
No specific changesNo impurities and
No specific changesCDM-18-0161-
01
2Capacity testWeight differenceCapacity error of;
Standard Capacity
$\u00b1 5 %$2.75 %CDM-18-0161-
02
3Package testBare eyesNo damageNo damages, cracksCDM-18-0161-
03
4Film ThicknessISO 4049:2009
7.5$\u2264 50 \u00b5m$$2 \u00b5m$CDM-18-0161-
04
5Sensitivity to
Ambient LightISO 4049:2009
7.9Must be physically
uniformHomogeneousCDM-18-0161-
05
6Depth of CureISO 4049:2009
7.10$\u2265 1.5 mm$3.0 mmCDM-18-0161-
06
7Bonding
Strength
(Dentin)ISO 29022:2013
7$\u2265 8 MPa$16 MPaCDM-18-0161-
09
8Bonding
Strength
(Enamel)ISO 29022:2013
7$\u2265 8 MPa$14 MPaCDM-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.