(120 days)
Dentin Conditioning and Adhesive System (Bond-1) is used for adhesion to Dentin of various polymeric filling materials (composites) used with other conditioners or combination of conditioners for bonding of composite to metal including amalgam, gold, semi precious and non precious alloys, porcelain and glass and luting of same to dentin and enamel.
We are adding a component called Bond-1 Self Cure Activator to be used in conjunction with Dentin Conditioning and Adhesive System (Bond-1). The formula for Bond-1 Self Cure Activator is attached in the application.
Dentin Conditioning and Adhesive System (Bond-1) is used for adhesion to Dentin of various polymeric filling materials (composites) used with other conditioners or combination of conditioners for bonding of composite to metal including amalgam, gold, semi precious and non precious alloys, porcelain and glass and luting of same to dentin and enamel.
We are adding a component called Bond-1 Self Cure Activator to be used in conjunction with Dentin Conditioning and Adhesive System (Bond-1). The formula for Bond-1 Self Cure Activator is attached in the application. Bond-1 Self Cure Activator, when mixed with Dentin Conditioning and Adhesive System, allows the Bond-1 C&B to cure with or without the use of light.
The provided text is a 510(k) summary for a dental adhesive system (Dentin Conditioning and Adhesive System (Bond-1)) seeking to add a new component, Bond-1 Self Cure Activator. This document is a regulatory filing, not a scientific study report. Therefore, it does not contain the acceptance criteria or a study demonstrating the device meets those criteria.
The information typically found in such a study would include:
- Acceptance Criteria for Performance: These would define the minimum performance thresholds for the dental adhesive, such as bond strength (e.g., megapascals of shear or tensile bond strength) to dentin and other restorative materials, or microleakage scores. These criteria would likely be based on international standards (e.g., ISO standards for dental materials) or established clinical benchmarks.
- Reported Device Performance: This would be the actual measured performance of the device (Bond-1 with the Self Cure Activator) in laboratory tests, compared against the acceptance criteria.
- Study Design: Details about the type of study (e.g., in vitro bond strength test, microleakage study), sample sizes for the test groups (e.g., number of teeth, number of bonded specimens), and the materials used.
- Data Provenance: Information on where the tests were conducted.
- Ground Truth Establishment: For dental materials, "ground truth" often refers to the objective measurement of a physical property (like bond strength). This is not typically established by human experts in the same way as an imaging device. Instead, it's determined by standardized laboratory procedures and equipment (e.g., universal testing machine for bond strength).
- Training Set Data: This kind of dental material study typically doesn't involve "training sets" in the machine learning sense. The performance is measured directly.
Summary based on the provided text:
This document is a 510(k) Pre-market Notification for a modification to an existing dental adhesive system. It does not present a study or acceptance criteria for the device's performance. Instead, it states that a new component (Bond-1 Self Cure Activator) is being added to an already approved device (Dentin Conditioning and Adhesive System (Bond-1), previously approved under K973388). The goal of this filing is to demonstrate substantial equivalence to the predicate device, not necessarily to re-demonstrate comprehensive performance against specific acceptance criteria in a new study.
The text does not include the following information that would be necessary to answer the prompt directly:
- A table of acceptance criteria and the reported device performance.
- Sample sizes used for any test set or data provenance.
- Number of experts used to establish ground truth or their qualifications.
- Adjudication method for a test set.
- Information on a Multi-Reader Multi-Case (MRMC) comparative effectiveness study.
- Information on a standalone algorithm performance.
- The type of ground truth used (beyond implying standardized material testing if a study were present).
- Sample size for a training set.
- How ground truth for a training set was established.
In essence, the provided document is a regulatory letter acknowledging receipt and review of a 510(k) submission, and the 510(k) summary itself is a description of the device and its intended use, rather than a detailed report of a study and its results against acceptance criteria.
§ 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.