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Multi-Cure composite cement is used as a luting cement for veneers, crowns, and bridges for anterior and posterior teeth. Composite restorative materials were developed by Dr. Raphael Bowen working for American Dental Research. The main innovation was Bisphenol A-Glycidyl Methacrylate (Bis-GMA), a dimethacrylate resin with silane coated filler (quartz) particles. These coated particles could bond chemically to the Bis-GMA resin. This is recommended for use for Classes III to V and for Class I when oclusal stress is not a problem and appearance is crucial. Although less durable than amalgam composite designed for Class II posterior applications, it is now used in about 20% of these restorations also.

Multi-Cure Composite Cement. The base paste and catalyst paste when mixed together form an exothermic reaction. When a standard dental curing light in the visible wave-length range is used it will cause the camphorquinone and the liquid "A" dimethylaminoethyl methacrylate to accelerate this reaction.

The provided text is a 510(k) clearance letter from the FDA for a dental composite cement. It does not include information about acceptance criteria for a device's performance, nor does it describe a study proving the device meets any such criteria.

The document is a regulatory approval, stating that the device is "substantially equivalent" to legally marketed predicate devices. This means it met the administrative and safety/effectiveness requirements for its class, not that a specific performance study against defined acceptance criteria was conducted and reported here.

Therefore, I cannot fulfill your request to describe acceptance criteria and a study from the provided text. The document simply isn't structured to provide that information for the following reasons:

1. No Acceptance Criteria or Reported Performance: The document does not contain any tables of acceptance criteria or reported device performance metrics. It's a regulatory clearance letter, not a performance study report.
2. No Study Description: There is no mention of a specific study, sample sizes, data provenance, ground truth establishment, expert involvement, or any other details related to a performance study for the Multi-Cure Composite Cement.
3. No MRMC or Standalone Studies: Since no study is described, there's no mention of MRMC comparative effectiveness studies or standalone algorithm performance.
4. No Training Set Information: Similarly, there is no information about a training set or how ground truth for a training set was established, as this would pertain to a performance study or algorithm development, neither of which is detailed here.

In summary, the provided document is a regulatory approval for a dental composite cement based on substantial equivalence, not a report detailing performance study results against acceptance criteria.

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Zinc phosphate cement is without any adhesive properties and is used as a luting agent. It is always referred to as a cement and is used for the attachment of indirect restorations and appliances to the teeth and for the cementation of inlays, crowns, bridges, facings, and orthodontic brackets.

Zinc Phosphate is the oldest of the cementation agents and thus the one with the longest track record (introduced in 1878). It serves as a standard by which newer systems can be compared. It consists of powder and liguid in two separate bottles. The main ingredients of the powder are zinc oxide and magnesium oxide. The liquid contains phosphoric acid, distilled water, alumina hydrate, and zinc oxide. Zinc phosphate cement is without any adhesive properties and is used as a luting agent. It is always referred to as a cement and is used for the attachment of indirect restorations and appliances to the teeth and for the cementation of inlays, crowns, bridges, facings, and orthodontic brackets.

I am sorry, but the provided text is a 510(k) clearance letter for a Zinc Phosphate Cement and contains no information about acceptance criteria or a study proving that a device meets those criteria. The document is a regulatory approval letter, not a scientific study report. Therefore, I cannot extract the requested information.

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Glass Ionomer cement is used in a luting application and referred to as a cement for the attachment of indirect restorations and appliances to the teeth. The glass ionomer cements also bond adhesively to tooth structure and they inhibit infiltration of oral fluids at the cement-tooth interface.

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I apologize, but the provided text from the FDA 510(k) notification for Medental Glass Ionomer Cement Type I and Mirage Glass Ionomer does not contain any information regarding acceptance criteria or a study proving the device meets said criteria.

The document is a letter from the FDA stating that the device is substantially equivalent to a predicate device and can therefore be marketed. It outlines regulatory requirements and contact information for further inquiries.

Therefore, I cannot provide the requested information, including:

• A table of acceptance criteria and reported device performance
• Sample size used for the test set or data provenance
• Number of experts used to establish ground truth or their qualifications
• Adjudication method
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done
• If a standalone (algorithm only) performance study was done
• The type of ground truth used
• The sample size for the training set
• How the ground truth for the training set was established

To provide this information, you would need to supply a different document, such as a summary of safety and effectiveness, a clinical study report, or a pre-market approval application summary, which typically contains details about performance testing and acceptance criteria.

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This is recommended for use for Classes III to V and for Class I when oclusal stress is not a problem and appearance is crucial. Although less durable than amalgam composite designed for Class II posterior applications, it is now used in about 20% of these restorations also.

Chemical Cure Composite with Enamel Bond

I am sorry, but based on the text provided, I cannot answer your request. The document is a 510(k) clearance letter from the FDA for a dental composite material. It confirms that the device is substantially equivalent to previously marketed devices. However, it does not include information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, or effects of AI assistance. The document focuses on regulatory approval rather than detailed study results.

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This is a chemically activated adhesive that is used in the cementation of inlays, crowns, bridges, facings, and orthodontic brackets. It may also be used as a cavity lining under all restorative materials or following root canal treatment. This adhesive is also used in the cementation of temporary fillings and fillings in deciduous teeth.

Polycarboxylate Cement

This is a 510(k) clearance letter for a Polycarboxylate Cement. 510(k) submissions for devices like this, which are physical materials used in dentistry, typically do not involve the kind of performance studies with acceptance criteria, human experts, and ground truth detailed in your request. Such studies are more common for AI/ML-driven devices or diagnostic tools.

Therefore, I cannot provide the information requested from the provided text for the following reasons:

• Type of Device: Polycarboxylate Cement is a dental restorative material, not an AI-powered diagnostic or predictive device. Its clearance relies on demonstrating substantial equivalence to a legally marketed predicate device, primarily through material properties, biocompatibility, and intended use, rather than clinical performance metrics against a "ground truth" derived from expert interpretation.
• Lack of Clinical Study Details: The provided document is a clearance letter, not a summary of a clinical study or a detailed technical submission. It states that the device is "substantially equivalent" to predicate devices. This equivalence is typically demonstrated through bench testing and comparisons of characteristics, not through studies involving human readers or complex ground truth adjudication.

In summary, there is no information in the provided text to complete the requested table and answer the specific questions about acceptance criteria, clinical study design, expert involvement, or AI/ML performance metrics.

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Cavity varnish is used for sealing cavities before restorations. It provides a barrier against the passage of irritants from cements or other restorative materials and reduces the penetration of oral fluids at the restoration-tooth interface into the underlying dentin. It also minimizes postoperative sensitivity when applied to dentinal surfaces under newly placed restorations.

Cavity Varnish (Intermediary Varnish and Dentinal Tubuli Seal)

Acceptance Criteria and Device Performance for Dentinal Tubuli Seal:

Based on the provided documents, it is not possible to extract specific quantitative acceptance criteria or detailed study results for the Dentinal Tubuli Seal. The documents are a 510(k) clearance letter from the FDA, indicating that the device has been found substantially equivalent to a legally marketed predicate device. This type of clearance typically relies on demonstrating equivalence in terms of indications for use, technological characteristics, and safety and effectiveness, rather than meeting specific pre-defined quantitative performance metrics in a new clinical study.

Therefore, the following sections will indicate "Not Applicable" or "Not Provided" where the requested information is not present in the given FDA letter.

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance:

• Sample Size: Not provided in the document. 510(k) clearance often relies on existing data from the predicate device and potentially product specifications rather than a new standalone clinical test set.
• Data Provenance: Not provided in the document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Number of Experts: Not provided in the document.
• Qualifications of Experts: Not provided in the document.

4. Adjudication method for the test set:

• Adjudication Method: Not provided in the document.

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:

• MRMC Study: Not applicable. This device is a cavity varnish, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Standalone Performance: Not applicable. This device is a physical product (cavity varnish), not an algorithm.

7. The type of ground truth used:

• Type of Ground Truth: Not explicitly stated. For a 510(k) submission of a cavity varnish, ground truth would typically be established based on accepted dental practices, material science principles, and existing clinical data or performance data of the predicate device, rather than patient outcomes or pathology from a new study.

8. The sample size for the training set:

• Sample Size for Training Set: Not applicable. This device is a physical product, and the concept of a "training set" as understood in machine learning/AI does not apply.

9. How the ground truth for the training set was established:

• Ground Truth for Training Set: Not applicable. The concept of a "training set" does not apply to this device.

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This is a chemically activated sealant that is used to seal the pit and fissures found in young teeth. This sealant assures complete cure in deep fissures.

Chemically Activated Pit and Fissure Sealant

I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a dental sealant. It does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment. Therefore, I cannot fulfill your request to describe these aspects of the device's evaluation.

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