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Kerr Temp Bond Clear Temporary Cement is indicated for use for temporary crown and bridge cementation procedures.

Kerr's Temp Bond Clear is designed to fulfill all of the requirements of a successful temporary restorative cementation material. These requirements are itemized below.

1. Ease of placement. Kerr Temp Bond Clear handles very similarly to the ZOE cements alresdy familiar to dentists.
2. Convenience. The chemical cure characteristics of Temp Bond Clear provide for a quick and simple procedure,
3. Aesthetics. The highly translucent nature of Temp Bond Clear provides a pleasing, tooth-like appearance even when margins are exposed.
4. Strength. The glass reinforced resin resists mastication forces that would fracture a ZOE type cement.

Here's an analysis of the provided text regarding the acceptance criteria and study for Kerr Temp Bond Clear Temporary Cement:

1. Table of Acceptance Criteria and Reported Device Performance

The document defines "efficacy" as "suitability to the intended purpose," which is demonstrated by a combination of in-house testing and side-by-side comparisons to predicate devices. The acceptance criteria are implicitly set by the performance of predicate devices already on the market (Temp Bond ZOE in this case), with the goal of performing "as well or better."

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not explicitly stated. The document refers to "cured samples" for biocompatibility and "bench testing" and "comparison" for efficacy.
• Data Provenance: The biocompatibility tests were conducted by an "independent laboratory," and efficacy tests were "in-house testing." No country of origin is specified, but the submission is to the US FDA. The studies appear to be prospective (bench testing conducted for the purpose of this submission).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• Number of Experts: Not applicable. The "ground truth" for the performance characteristics (e.g., tensile strength, water solubility) is established through standardized material testing methods, not expert consensus.
• Qualifications of Experts: N/A.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. The data presented is quantitative performance data from material testing, not subjective assessments requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study typically involves human readers assessing diagnostic images or clinical scenarios, which is not relevant for a dental cement.

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

• Standalone Performance: Not applicable. This device is a dental cement, not a software algorithm. The "standalone" performance refers to its physical and chemical properties and how it functions as a material. The provided data reflects the inherent properties of the material itself in laboratory settings.

7. The Type of Ground Truth Used

• Type of Ground Truth: The ground truth for the efficacy evaluation is based on objective, quantifiable material properties determined through standardized laboratory testing (e.g., diametral tensile strength, water solubility, film thickness, fluoride release rate). The "ground truth" for comparison is the performance of predicate devices in the market, which themselves have established performance characteristics.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This refers to a medical device's physical/chemical properties study, not an AI/ML model that would have a training set.

9. How the Ground Truth for the Training Set was Established

• Ground Truth for Training Set: Not applicable, as there is no training set for an AI/ML model for this dental cement.

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