Search Results

Used for bases, linings and to cement crowns and bridges.

It decreases post-operative sensitivity. Bonds to tooth structure.

Glass Ionomer cement called Desens-Ionomer

The provided document is a 510(k) clearance letter from the FDA for a dental cement called "Desens-Ionomer." This type of document does not contain the information requested in your prompt.

Specifically, a 510(k) clearance determines if a new medical device is "substantially equivalent" to an existing legally marketed device (predicate device). It does not typically require the extensive clinical study data, acceptance criteria, or performance metrics that would be found in a Premarket Approval (PMA) application or a detailed clinical study report for software, especially AI-driven medical devices.

Therefore, I cannot extract the following information from the provided text:

• Table of acceptance criteria and reported device performance: This document doesn't define specific performance metrics or acceptance criteria for the "Desens-Ionomer" beyond its stated indications for use (bases, linings, cementing crowns/bridges, decreasing post-operative sensitivity, bonding to tooth structure).
• Sample size used for the test set and data provenance: No clinical study details are provided.
• Number of experts used to establish ground truth and their qualifications: Not applicable to this type of regulatory document.
• Adjudication method: Not applicable.
• Multi-reader multi-case (MRMC) comparative effectiveness study: Not mentioned and unlikely for a dental cement 510(k).
• Standalone (algorithm only) performance: Not applicable as this is a physical dental cement.
• Type of ground truth used: No mention of ground truth as a clinical study is not detailed.
• Sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

The letter confirms that the FDA reviewed the 510(k) premarket notification and determined the device is substantially equivalent to legally marketed predicate devices for the stated indications for use.

Ask a specific question about this device

USED AS A Composite RESTORATIVE to REPAIR CARIOUS LESIONS MATERÍAL FOR VENEERING. AND DoTASSIum CONTA

Not Found

I am sorry, but based on the provided text, there is no information about acceptance criteria for a device, a study that proves a device meets such criteria, or any of the detailed aspects like sample sizes, expert qualifications, or ground truth establishment.

The document is a 510(k) clearance letter from the FDA for a device named "Composite Restoration Material." This letter primarily addresses:

• Device Name: Composite Restoration Material
• Regulation Number/Name: 872.3690 / Tooth Shade Resin Material
• Regulatory Class: II
• Product Code: EBF
• FDA Determination: Substantially equivalent to legally marketed predicate devices.
• Conditions: The device can be marketed subject to general controls (registration, listing, GMP, labeling, etc.).
• Indications for Use: Used as a Composite Restorative to repair carious lesions, material for veneering.

This type of document confirms that the device is substantially equivalent to existing devices and can be marketed. It does not contain the results of a performance study with acceptance criteria, performance metrics, or details about the study design or data used to demonstrate those metrics. Therefore, I cannot provide the requested table or answer the specific questions about a study from the given text.

Ask a specific question about this device

FOR LINING AND BASES UNDER AMALGAM AND/OR Composite RESTORATIONS AND FOR LUTING FULL CROWNS TO PREPARED TEETH.

Not Found

This document is a letter from the FDA to Dr. Milton Hodosh regarding the 510(k) premarket notification for the "Preserve Cavity Liner" (later referred to as not yet named, but a modification of "Potassium MIRRY's Lycon Epoxy LGTF DEVITAL CEMENT").

The letter approves the device as substantially equivalent to legally marketed predicate devices. However, this document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or any of the other specific details requested in your prompt.

The document is an approval letter for a medical device based on its substantial equivalence to previously approved devices, not a study report. Therefore, I cannot extract the requested information from this text.

Ask a specific question about this device