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UltraTemp is a non-eugenol temporary cement indicated for interim cementation of inlays, orowns and bridges. It is polycarboxylate based and does not negatively affect resin bonding. Being water soluhle until set, it cleans up easily.

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This document is a 510(k) premarket notification from the FDA regarding a dental cement called UltraTemp Temporary Polycarboxylate Cement. It is not an AI/ML device, therefore, the requested information about acceptance criteria, study data, sample sizes, expert ground truth, adjudication methods, and comparative effectiveness studies is not applicable.

The document indicates that the device has been found substantially equivalent to predicate devices marketed before May 28, 1976, and can therefore be marketed subject to general controls provisions of the Act.

The "Indications For Use" section on page 2 defines the purpose of the device:

• Device Name: UltraTemp Temporary Polycarboxylate Cement
• Indications For Use: UltraTemp is a non-eugenol temporary cement indicated for interim cementation of inlays, crowns, and bridges. It is polycarboxylate-based and does not negatively affect resin bonding. Being water-soluble until set, it cleans up easily.

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For temporary or permanent cementation of crowns and bridges on non-vital and vital teeth where retention is of primary concern. Also for use as temporary filling material.

Carbocem Zinc Polycarboxylate Cement

This document is a 510(k) clearance letter from the FDA for a dental cement called Carbocem. It does not contain information about acceptance criteria or a study proving device performance in the context of the questions asked. The questions appear to be geared towards AI/ML device evaluations, which is not applicable to this traditional medical device clearance.

Therefore, I cannot provide the requested information based on the provided text.

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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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