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Core material- when a tooth is fractured a Technique called Post and core is used to restore functum. A post is cemented into the endo dentically Treated tooth. A core material is used to build up around the tooth and post so that a finished appliance can be placed.

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This appears to be a 510(k) clearance letter from the FDA for a dental core material, not a document describing a study for an AI/ML powered device. Therefore, the requested information regarding acceptance criteria, study details, ground truth, and expert involvement is not present in this document.

The document states that the device is "substantially equivalent" to legally marketed predicate devices, which is the basis for its clearance, and does not involve performance studies against acceptance criteria in the way an AI/ML device would.

Therefore, I cannot provide the requested table and study details.

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PermaCem® is a compomer based permanent luting cement to be applied by the dental professional prior to the cementation of crowns, bridges, inlays, onlays and veneers in patients.

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I am sorry, but based on the provided text, I cannot provide the detailed information required for the acceptance criteria and the study that proves the device meets those criteria. The document is a 510(k) clearance letter from the FDA for a dental luting cement system (PermaCem® Automix Luting Cement System).

This type of letter primarily indicates that the FDA has determined the device is substantially equivalent to a legally marketed predicate device, meaning it can be marketed. It does not present the detailed acceptance criteria, device performance results, study design, or ground truth establishment that would be found in a clinical study report or a more comprehensive premarket submission.

The document mentions:

• Device Name: PermaCem® Automix Luting Cement System
• Indications for Use: "PermaCem® is a compomer based permanent luting cement to be applied by the dental professional prior to the cementation of crowns, bridges, inlays, onlays and veneers in patients."
• Regulatory Class: II
• Product Code: EBF
• Date: July 10, 1998

To answer your specific questions, I would need access to the actual premarket submission (510(k) file) or a summary of the clinical/performance data submitted to the FDA for this device, which is not contained within these pages.

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Honigum® Automix and Honigum® Quick are polysiloxane impression materials to be applied by the dental professional prior to fabrication of crowns, bridges and inlays for their patients.

polysiloxane impression materials

This document is a 510(k) clearance letter from the FDA for a dental impression material. It does not describe any acceptance criteria or a study proving that a device meets such criteria. It's a regulatory approval document confirming substantial equivalence to a predicate device, not a technical performance report.

Therefore, I cannot extract the requested information from this document.

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Zenith Flowable Composite is a tooth-shaded resin filling material for use as an esthetic anterior restoration or mase restoration under posterior or anterior composites.

Zenith Flowable Composite is a tooth-shaded resin filling material.

The provided text is a 510(k) premarket notification letter from the FDA to a dental device manufacturer. It confirms the substantial equivalence of the "Zenith Flowable Composite" to a legally marketed predicate device.

This document does NOT contain information about acceptance criteria, device performance studies, or the methodologies used to establish ground truth or conduct clinical trials.

Therefore, I cannot answer your request for the following reasons:

• No acceptance criteria or device performance data is present. The letter is a regulatory approval and does not detail performance metrics.
• No study information is provided. It does not describe any clinical trials, validation studies, or the data collected from such studies.
• No ground truth establishment methods are mentioned.
• No information on sample sizes, expert qualifications, or adjudication methods is available.
• No details on standalone performance or MRMC studies are included.
• No training set information is provided.

The document is purely administrative, confirming the device's marketability based on its substantial equivalence to a pre-existing device. If your query relates to the regulatory process for proving substantial equivalence, then the document confirms that the device was deemed substantially equivalent based on information submitted in the 510(k) application (K970683). However, it does not provide the specifics of that information regarding performance studies.

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TempoCem N/E is a dental luting agent for the temporary cementation of crowns and bridges.

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The document provided is a 510(k) premarket notification letter from the FDA for a dental luting agent called TempoCem N/E. It does not contain any information about acceptance criteria or a study proving the device meets those criteria, as it is not a medical imaging or AI-driven device.

Therefore, I cannot fulfill your request using the provided text. The document is about a dental cement and its regulatory approval process, not about a device that undergoes performance studies with acceptance criteria, sample sizes, expert ground truth, or MRMC studies.

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TempoCem is a dental luting agent for the temporary cementation of provisional crowns and bridges.

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The provided text is a 510(k) premarket notification letter from the FDA to Foremost Dental Mfg, Incorporated regarding their device, TempoCem. This letter confirms that the device is substantially equivalent to legally marketed predicate devices and can proceed to the market.

However, the document does not contain any information about acceptance criteria or the study that proves the device meets those criteria.

The document primarily focuses on:

• The FDA's determination of substantial equivalence.
• Regulatory classification of the device (Class II).
• General controls provisions of the Act that apply to the device.
• Instructions for the manufacturer regarding labeling and promotion inquiries.
• Indications for use for TempoCem (temporary cementation of provisional crowns and bridges).

Therefore, I cannot provide the requested information as it is not present in the given text.

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Ionosit Seal is a dental pit and fissure sealant intended to be used to seal the pits and fissures of occlusual non-carious posterior teeth.

A one-component light cured liquid resin. Lightly filled with a fluoride containing glass powder.

This document describes the safety and effectiveness of IONOSIT SEAL PIT & FISSURE SEALANT. It primarily relies on in-vitro testing and comparison to a predicate device.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly set by the performance of the predicate device, Fluoro-Shield. The study aims to demonstrate substantial equivalence to the predicate device in terms of physical properties.

Note: While some values for Ionosit Seal are quantitatively different from Fluoro-Shield, the submission claims "it was equivalent to Fluoro-Shield" in "critical areas of adhesion and leakage," implying the differences are considered acceptable for substantial equivalence. The document doesn't explicitly state numerical acceptance thresholds.

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

• Sample Size: Not specified in the provided text. The tables show single values for each property, implying either a single measurement or an average of an unspecified number of measurements.
• Data Provenance: The study was conducted by Daniel Chan, DMD, MS, DDS, at The University of Texas Health Science Center at San Antonio Dental School, USA. The data is from in-vitro tests only, not from human subjects. The text describes it as a "reprint," suggesting it was a previously conducted study.

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

Not applicable. The study is an in-vitro comparison of physical properties of dental sealants, not a clinical study requiring expert assessment of ground truth. The "ground truth" here is the measured physical properties of the materials.

4. Adjudication method for the test set

Not applicable. This was an in-vitro laboratory test of material properties, not a clinical study involving human assessment or adjudication of results.

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 is a submission for a dental material (pit and fissure sealant), not an AI device.

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

Not applicable. This is not an AI device. The in-vitro testing represents a standalone evaluation of the material's physical properties.

7. The type of ground truth used

The "ground truth" for this study is derived from standardized in-vitro laboratory measurements of physical properties (e.g., compressive strength, tensile strength, shear bond strength, volume change, water uptake, water solubility). The predicate device's performance established the benchmark for comparison.

8. The sample size for the training set

Not applicable. This is not an AI device or a machine learning study. There is no concept of a "training set."

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

Not applicable, as there is no training set for this type of submission.

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