(105 days)
BRUSH&BOND® PLUS is indicated for:
- Direct Dental Restorations (e.g., resin-modified glass ionomer, resin core build-ups, compomers).
- Indirect Dental Restorations (e.g., metal, resin-based composite, dental ceramics (e.g., porcelain, pressed ceramic, lithium disilicate, zirconia).
- Desensitization of dentin.
- Sealing of dentin, cementum or enamel.
BRUSH&BOND® PLUS is a self-etching. self-priming. light-cured bonding system which utilizes proven 4-META chemistry to enhance penetration into prepared enamel and dentin surfaces and to establish strong bonds to dental surfaces such as restorative composites, metals, dentin, enamel, cementum, and dental ceramics (e.g., porcelain, lithium, disilicate, zirconia, or hybrid ceramics). The Device is useful for all direct dental restorations, desensitizing teeth, and sealing tooth structures against microleakage. Moreover, the Device can be used without prior acid-etching of dentin or cutting of enamel surfaces.
The BRUSH&BOND® PLUS device is essentially a single-bottle, two-component system, comprising: a liquid resin which comprises monomers and 4-META chemistry, and an activator brush which comprises a bonding promoter to ensure complete activation and polymerization when contacted with the liquid resin. After activation, the activated resin can be applied directly onto restorative surfaces (except dental ceramic surfaces) using the activator brush or any appropriate dental instrument. For ceramic surfaces, the surface must first be coated with a ceramic primer (such as EaZy Primer'M,510K no. 142848) before the activated resin is applied.
BRUSH&BOND® PLUS is packaged as a single 3 mL bottle of liguid resin, an accompanying canister containing 100 activator brushes (either standard size or mini/endo size), and accompanying bottles of Parkell's ceramic rimer Ea Primer'M 5mL "A" and "B" bottles).
The provided text does not contain the acceptance criteria or a study proving that the "Brush & Bond® Plus" device meets such criteria.
This document is a 510(k) premarket notification for a dental bonding agent. It aims to demonstrate substantial equivalence to previously cleared devices, rather than presenting a study where specific acceptance criteria are defined and then met by the device's performance.
Here's a breakdown of why the requested information is largely absent given the input:
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Acceptance Criteria and Reported Device Performance: The document doesn't provide a table of acceptance criteria or specific performance metrics that "Brush & Bond® Plus" is required to meet as a standalone device against a pre-defined standard in real-world or simulated clinical scenarios. Instead, it compares its properties (like bond strength and biocompatibility) to predicate devices to establish substantial equivalence.
- What is reported: The document states, "The Shear and Tensile Bond Strength tests were performed in accordance with ISO/TS 11405. The shear and tensile strength tests were compared to the Predicates and were determined to be equivalent." This indicates comparative testing, not testing against independent acceptance criteria.
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Sample size used for the test set and data provenance: Not explicitly mentioned for the bond strength tests. The document only states that "The shear and tensile strength tests were compared to the Predicates," without detailing the number of samples or whether the data was prospective or retrospective, or its country of origin.
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Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable. The testing seems to be laboratory-based (shear and tensile bond strength tests), not dependent on expert interpretation of clinical data in the way a diagnostic AI device would be.
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Adjudication method: Not applicable for this type of test.
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Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable. This type of study is relevant for diagnostic devices where human readers interpret images or data. This document is for a dental bonding agent, and the evaluation focuses on physical and chemical properties.
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Standalone performance: The document describes "non-clinical testing" including "Shear and Tensile Bond Strength tests" performed in accordance with ISO/TS 11405. This refers to laboratory testing of the material's properties, which could be considered a form of standalone performance evaluation for the material itself, but not in the context of an "algorithm only without human-in-the-loop performance" typical for AI devices.
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Type of ground truth used: For the bond strength tests, the "ground truth" would be the measured physical properties (e.g., force required to break the bond) obtained through standardized testing methods (ISO/TS 11405), rather than expert consensus, pathology, or outcomes data.
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Sample size for the training set: Not applicable, as this is not an AI/machine learning device.
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How the ground truth for the training set was established: Not applicable.
In summary, the provided document focuses on demonstrating substantial equivalence of a dental bonding agent to existing predicate devices based on technological characteristics and non-clinical performance (like bond strength and biocompatibility), rather than presenting a study of a diagnostic AI device against pre-defined 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.