(67 days)
Bond-3 Adhesive is used for the adhesion of tooth (dentin and enamel) to various polymeric filling materials (composites) and used with other conditioners or combination of conditioners for bonding composite to metal including amalgam, gold, semi precious, and non precious alloys, porcelain and glass and luting of same to Dentin and Enamel.
Bond-3 Adhesive and Dentin Conditioning Adhesive System (Bond-1) K936222 contain the same materials. However, Bond-3 Adhesive Contains additional Methacryl-POSS for added improvements. Safety and effectiveness have not been affected.
This document is a 510(k) submission for a dental adhesive (Bond-3 Adhesive). It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria and results.
Therefore, many of the requested details about acceptance criteria, study design, and performance metrics are not available in the provided text. The submission explicitly states that "Safety and effectiveness have not been affected" by the addition of Methacryl-POSS, implying that the performance is considered similar to the predicate device (Bond-1 Adhesive K936222) which shares the same materials.
Here's a breakdown of what can and cannot be extracted from the given text:
1. A table of acceptance criteria and the reported device performance:
- Not available. The document states that Bond-3 Adhesive contains additional Methacryl-POSS for "added improvements" and then asserts "Safety and effectiveness have not been affected." This is a claim of equivalence, not a presentation of specific acceptance criteria or performance data for Bond-3 itself. For a dental adhesive, acceptance criteria would typically involve bond strength (e.g., shear or tensile bond strength) to dentin, enamel, and various restorative materials, as well as biocompatibility, shelf life, and handling properties. None of these are detailed here.
2. Sample size used for the test set and the data provenance:
- Not available. No specific test set or study data is presented to evaluate the performance of Bond-3 Adhesive against acceptance criteria. The submission relies on the substantial equivalence to a predicate device (Bond-1 Adhesive K936222) which is stated to contain the same materials.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not available. Since no specific performance study is detailed, there's no mention of a test set requiring expert ground truth establishment.
4. Adjudication method for the test set:
- Not applicable/Not available. As above, no performance study or test set is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This device is a dental adhesive, not an AI-powered diagnostic or assistive tool. MRMC studies are irrelevant in this context.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable/Not available. No specific performance study is detailed where ground truth would be established. The regulatory decision is based on substantial equivalence.
8. The sample size for the training set:
- Not applicable/Not available. This is a physical dental adhesive, not a machine learning model, so there is no "training set."
9. How the ground truth for the training set was established:
- Not applicable/Not available. As above, no training set exists for this device.
Summary based on the provided text:
The provided document is a 510(k) summary for a dental adhesive. It aims to demonstrate substantial equivalence to a previously cleared predicate device (Bond-1 Adhesive K936222). The key assertion is that the addition of Methacryl-POSS to Bond-3 Adhesive does not adversely affect safety and effectiveness, implying its performance is comparable to the predicate. There are no detailed performance studies, acceptance criteria, or specific test results presented in this submission. The FDA's letter confirms that the device is "substantially equivalent" to legally marketed predicate devices, allowing it to proceed to market under general controls.
§ 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.