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