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• 1. All direct restorations
• 2. All indirect restorations
• 3. Desensitizing/sealing of tooth
• 4. Intra-oral repairs

It is a 7th generation dentin adhesive system that handles all the functions of the conditioner primer bonding resin. The polymerization method is photopolymerization type, and after being applied to the tooth surface, the solvent is volatilized and polymerized in the drying process to perform the function as a dentine adhesive.

The provided text describes a 510(k) premarket notification for a dental resin bonding agent, DIAPLUS Universal (K213401). This submission aims to demonstrate substantial equivalence to a predicate device, ALL-BOND Universal w/BAC (K161051).

However, this document does not contain information about an AI-powered medical device or software that would have "acceptance criteria" related to AI performance metrics like accuracy, sensitivity, specificity, or the results of a multi-reader multi-case (MRMC) study.

Instead, the document focuses on demonstrating the substantial equivalence of a physical dental product (resin tooth bonding agent) through:

• Comparison of Indications for Use, Composition, and Principle of Operation with a predicate device.
• Non-clinical performance data which includes physical property tests (e.g., film thickness, shear bonding strength, sensitivity to light, occlusion of dentinal tubules) and biocompatibility tests (e.g., cytotoxicity, genotoxicity, irritation, systemic toxicity) conducted according to established international standards (ISO).
• A statement that no clinical performance data was collected because it was not deemed necessary to demonstrate substantial equivalence for this type of device.

Therefore, it is not possible to answer the request based on the provided text, as the document does not describe an AI medical device or a study proving its performance against AI-specific acceptance criteria.

The questions in your prompt (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, type of ground truth, training set details) are relevant for AI/ML-based medical device submissions, but they do not apply to the traditional dental material device described in this specific FDA 510(k) clearance document.

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As a dentine/enamel total etching bonding system for direct adhesion, it is used in the adhesion of all direct restoration substances.

• Bonding of direct composite
• Bonding to composite and set amalgam
• Bonding of indirect restoration-Porcelain, Composite (Inlays, Onlays, Veneers, Crowns)

DiaPlus is a photopolymerization type dentine and enamel adhesive as a 5th generation dentine adhesion system that can be applied to all types of composite resin restorations.

The provided text details a 510(k) premarket notification for a dental bonding agent named DiaPlus, aiming to demonstrate its substantial equivalence to a legally marketed predicate device (BC Plus).

However, the document does not contain information about an AI/ML-driven device or an AI/ML-based study with acceptance criteria and associated performance. The 510(k) submission relates to a physical dental bonding agent and its chemical composition, physical properties, and biocompatibility testing. The "study" referenced in the prompt (acceptance criteria, sample sizes, expert ground truth, MRMC, etc.) is consistent with a performance study for an AI/ML medical device, which is not what this document describes.

Therefore, it's not possible to extract the requested information from the provided text. The document focuses on bench testing and biocompatibility for a dental material, not an AI/ML algorithm.

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