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The Prime-Dent® Dual Cure Composite Luting Cement is a light and chemical curing, filled composite, multi-purpose permanent cement. This material can be used for final cementation of crowns, bridges, inlay, onlays, veneers, posts and pins, and cementation of orthodontic bands and appliances.

Prime-Dent® Dual Cure Composite Luting Cement is a light and chemical curing, filled composite, multi-purpose permanent cement.

I am sorry, but I cannot fulfill your request to describe acceptance criteria and associated studies for the "Prime-Dent® Dual Cure Composite Luting Cement" based on the provided text.

Here's why:

The provided document is a 510(k) substantial equivalence letter from the FDA. This letter indicates that the FDA has determined the device is substantially equivalent to a legally marketed predicate device. This process primarily relies on demonstrating that the new device has the same intended use and technological characteristics as a predicate device, or if it has different technological characteristics, that those differences do not raise different questions of safety or effectiveness.

This type of FDA letter generally does not contain the detailed acceptance criteria and study results you are asking for. It's a regulatory notification, not a scientific publication or a technical report of device performance studies.

Specifically, the document does not contain any of the following information requested in your prompt:

• A table of acceptance criteria and the reported device performance.
• Sample size used for the test set and data provenance.
• Number of experts used to establish ground truth and their qualifications.
• Adjudication method.
• MRMC comparative effectiveness study results or effect size.
• Standalone algorithm performance.
• Type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

The letter states the "Indications for Use" for the device, which describes what the cement is intended for (final cementation of crowns, bridges, etc.), but it doesn't provide performance metrics or studies to prove these indications.

To get the information you are looking for, you would typically need to consult a pre-market approval (PMA) application, a scientific publication, or the manufacturer's technical documentation, which are not found in this 510(k) clearance letter.

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Prime-Dent® Automix Dual Cure Core Build Up Material principal use is a dental core build-up material either with adhesives or with pins or posts.

Prime-Dent® Automix Dual Cure Core Build-Up Material

This is an FDA Premarket Notification (510(k)) K022675 for a dental material (Prime-Dent® Automix Dual Cure Core Build-Up Material), not a medical device that would typically undergo studies to demonstrate performance against computational acceptance criteria. The document is primarily concerned with establishing substantial equivalence to a predicate device based on material properties and intended use.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, and ground truth types is not applicable to this type of submission.

The FDA's review for this device focused on its intended use as a "dental core build-up material either with adhesives or with pins or posts" and its classification as a "Tooth Shade Resin Material" under 21 CFR 872.3690. Substantial equivalence was determined based on comparisons to legally marketed predicate devices, not through a performance study against specific computational metrics.

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Prime-Dent Light Cure Soft Dental Dam is for soft tissue isolation and moisture prevention/barrier.

Not Found

This document is a 510(k) premarket notification letter from the FDA regarding the "Prime-Dent Light Cure Soft Dental Dam." It states that the device is substantially equivalent to legally marketed predicate devices and can therefore be marketed.

However, this document does not contain any information about acceptance criteria or a study that proves the device meets specific performance criteria. The letter is a regulatory approval, not a technical performance report.

Therefore, I cannot provide the requested information. The document focuses on regulatory compliance and substantial equivalence to a predicate device, not on presenting experimental data regarding the device's performance against defined acceptance criteria.

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Prime-Dent® Hema Desensitizer is used by Dentists to seal dentinal tubules in the tooth cavity preparation or sensitive root surfaces. Prime-Dent® Hema Desensitizer is also used as a wetting agent prior to bonding resin fillings and composites.

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The provided document is an FDA 510(k) clearance letter for a dental desensitizer device. It does not contain any information regarding acceptance criteria or the study that proves the device meets those criteria.

The letter focuses on:

• Confirming that the device and its indications for use are substantially equivalent to a legally marketed predicate device.
• Outlining the regulatory requirements the manufacturer must comply with (e.g., registration, labeling, good manufacturing practice).
• Providing contact information for regulatory questions.

Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, study details, ground truth, or expert qualifications from this document. This kind of information would typically be found in the 510(k) premarket notification submission itself, not in the clearance letter.

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Prime-Dent® Chemical Cure Pit & Fissure Sealant (opaque and clear) is a BisGMA I Time-Dome Chomical Casin for the sealing of deciduos teeth and the filling of fissures in primary tooth structure.

Not Found

I am sorry, but the provided text from the FDA 510(k) summary for "Prime-Dent Chemical Cure Pit & Fissure Sealant" (K012794) does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.

The document is a letter from the FDA to the manufacturer, indicating that the device has been found substantially equivalent to a predicate device and can be marketed. It refers to the device's indications for use but does not delve into the detailed performance data that would typically be found in a study report.

Therefore, I cannot provide the requested table and study details based on the given information.

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Prime-Dent® Visible Light Cure Pit & Fissure Sealant (opaque and clear) is a BisGMA based visible light cured resin for the sealing of deciduos teeth and the filling of fissures in primary tooth structure.

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This is an FDA Premarket Notification (510(k)) for a dental sealant. This type of document declares "substantial equivalence" to a predicate device, meaning it's similar enough that it doesn't require new clinical trials like a premarket approval (PMA) would. Therefore, the document does not contain information about acceptance criteria or a study proving the device meets them.

The FDA letter explicitly states: "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent... to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976... You may, therefore, market the device..."

To answer the requested questions, one would need different documentation, such as a PMA submission or a clinical study report for a novel device.

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Prime-Dent® One-Step Orthodontic Adhesive Bonding System is a resin/paste system intended for bonding plastic, metal or ceramic orthodontic brackets to etched enamel. An active archwire may be placed immediately after adhesive has properly cured.

Not Found

I am sorry, but based on the provided text, there is no information about acceptance criteria, a study proving device performance, sample sizes, expert qualifications, or ground truth establishment. The document is an FDA 510(k) clearance letter for a dental adhesive bonding system, which primarily confirms the device's substantial equivalence to a predicate device and outlines regulatory compliance. It does not contain details of a clinical study or performance data that would answer your questions.

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Prime-Dent chemical cure composite restorative material is a direct filling dental composite used by licensed dentists to fill prepared cavities in teeth. Prime-Dent chemical cure composite restorative material is recommended for class III and class V restorations and for limited use in class I restorations in pre-molars and selected class IV restorations where esthetics are of primary importance.

Prime Dent chemical cure composite restorative material is a Bis GMA thermosetting resin with inorganic radiopaque barium borosilicate and glass quartz particles ranging from .04-10 micron average. The kit consists of 15gm catalyst paste, 15gm base paste, 3cc enamel bond catalyst, 3cc enamel bond base, and 7.5 ml etchant.

I am sorry, but the provided text does not contain the information required to answer your request. The text is a letter from the FDA regarding a 510(k) premarket notification for a dental restorative material, Prime-Dent Chemical Cure Composite. It discusses regulatory matters and indications for use but does not provide details about acceptance criteria, study methodologies, sample sizes, expert qualifications, or ground truth establishment for a device performance study.

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