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Eugenone is a eugenol-free temporary cement used in the placement of temporary or temporary placement of permanent prostheses.

Eugenone is a eugenol-free temporary cement.

This document is a 510(k) premarket notification decision letter from the FDA for a dental cement named "Eugenone." It's not a study report, and therefore, it does not contain the detailed information requested regarding acceptance criteria and performance studies for a device.

The letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device... and have determined that this device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976..."

This indicates that the device was cleared based on substantial equivalence to existing predicate devices, rather than through a new clinical performance study that would generate the kind of data you're asking for.

Therefore, I cannot provide the requested information for the following reasons:

1. Acceptance criteria and reported device performance: This document does not specify formal acceptance criteria for a new study, nor does it report on the device's performance against such criteria. The clearance is based on equivalence.
2. Sample size, data provenance: No new study data is provided, so these details are not available.
3. Number of experts, qualifications, adjudication method, ground truth type: These are all details related to a clinical study establishing ground truth, which is not present in this regulatory clearance document.
4. MRMC comparative effectiveness study: This is not mentioned as part of the review for substantial equivalence.
5. Standalone performance: Not applicable as no new performance study is detailed.
6. Training set sample size and ground truth establishment: Not applicable as this is not a study report with distinct training and test sets.

In summary, the provided document is a regulatory clearance letter, not a technical report detailing a performance study.

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Proviso™ is a self-cured material that is intended for the fabrication of temporary crowns and bridges.

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This document is a 510(k) clearance letter from the FDA for a dental device called Proviso™. It establishes substantial equivalence to a predicate device, which allows the new device to be marketed. However, this document does not contain any information about acceptance criteria or a study that proves the device meets those criteria.

The 510(k) process primarily relies on demonstrating that a new device is "substantially equivalent" to a legally marketed predicate device, meaning it has the same intended use and the same technological characteristics as the predicate, or, if it has different technological characteristics, it does not raise different questions of safety and effectiveness and is as safe and effective as the predicate device. This often involves comparing performance characteristics to the predicate, but the specific details of such comparative testing or acceptance criteria are typically found in the 510(k) submission itself, not in the clearance letter.

Therefore, I cannot provide the requested information based on the provided text. The document states: "We have reviewed your Section 510(k) premarket notification of intent to market the device we have determined the device is substantially equivalent...". This indicates the FDA reviewed data, but the data itself is not presented here.

To answer your questions, I would need to review the actual 510(k) submission document, which would detail the performance data, acceptance criteria, and specific studies conducted.

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For cementing dental posts inside prepared postholes, prior to rebuilding the missing coronal tooth structure.

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This document is a 510(k) clearance letter from the FDA for a dental cement product called "Sci-Pharm Post Secure." It indicates that the device has been found substantially equivalent to a legally marketed predicate device.

Crucially, this document is a regulatory approval letter and does not contain any information about acceptance criteria, study data, or performance metrics for the device. It's a notification of clearance, not a summary of a clinical or performance study.

Therefore, I cannot provide the requested information based on the provided text. The document states that the FDA "reviewed your Section 510(k) premarket notification of intent to market the device" and "determined the device is substantially equivalent." This determination is based on the information provided by the manufacturer in their 510(k) submission, which would include performance data, but that data itself is not present in this letter.

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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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For use as a varnish on sensitive teeth over exposed dentin and under temporary restoratives and cements.

The varnish has the consistency of a viscous liquid. When applied in a thin layer over tooth dentin, the solvent (ethyl alcohol and water) evaporates within a few minutes, leaving a film of Colophony resin in which Sodium Fluoride is suspended, which adheres well to the tooth structure.

This document focuses on the substantial equivalence of the Sci-Pharm DFV Varnish to legally marketed predicate devices, rather than establishing acceptance criteria or performance through a clinical study with numerical metrics like sensitivity, specificity, or accuracy.

The manufacturer, Scientific Pharmaceuticals, Inc., sought 510(k) clearance from the FDA for their Sci-Pharm DFV Varnish. The clearance relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device, not on meeting specific, pre-defined acceptance criteria through a clinical performance study.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

This type of table is not directly applicable here because the submission is based on substantial equivalence, not a performance study against specific acceptance criteria. Instead, the document compares the chemical composition and device function to predicate devices.

2. Sample Sizes and Data Provenance

This information is not applicable as there was no formal "test set" in the context of a clinical performance study. The data provenance relates to the analysis of the chemical composition and physical properties of the Sci-Pharm DFV Varnish and its predicate devices.

• Sample Size for Test Set: Not applicable (no clinical test set for performance metrics).
• Data Provenance: The data regarding chemical composition and physical properties were likely generated in-house by Scientific Pharmaceuticals, Inc., through laboratory tests (IR spectrophotometry, pyrolysis, viscosity and refractive index measurements, dry residue determination). The document doesn't specify if these were retrospective or prospective analyses, but they would have been performed specifically for the 510(k) submission.

3. Number and Qualifications of Experts for Ground Truth

This is not applicable. Ground truth, in the sense of expert consensus on clinical diagnoses or outcomes, was not required for this type of submission. The "ground truth" here is the established chemical composition and functional behavior of the predicate devices and the Sci-Pharm DFV Varnish, determined through analytical laboratory techniques.

4. Adjudication Method

This is not applicable. There was no adjudication method used as this was not a clinical study involving human assessment of outcomes.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not done. This type of study assesses the impact of a device (often AI) on human reader performance, which is not relevant to a 510(k) submission for substantial equivalence of a dental varnish.

6. Standalone (Algorithm Only) Performance Study

No, a standalone study was not done. This submission is for a physical dental varnish, not an algorithm or software. The closest analogy would be the in-lab testing of the varnish's chemical and physical properties to demonstrate its equivalence.

7. Type of Ground Truth Used

The "ground truth" used for this submission was based on:

• Chemical Analysis: Laboratory results from techniques like IR spectrophotometry, pyrolysis, viscosity and refractive index measurements, and dry residue determination to confirm the identity and concentration of ingredients in both the new device and the predicate devices.
• Established Device Function: The document refers to the "accepted worldwide" uses of varnishes with similar compositions, indicating an reliance on existing clinical understanding and historical data for this class of devices.

8. Sample Size for the Training Set

This is not applicable as this is not an AI/machine learning device requiring a training set.

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

This is not applicable for the same reason as above.

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Seals dentin tubulae in order to reduce post-operative sensitivity; will also improve the quality and functionality of restorations when used in conjunction with dental restoratives and cernents.

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I am sorry, but based on the provided text, there is no information about acceptance criteria or a study proving that the device meets acceptance criteria. The text provided is a 510(k) clearance letter from the FDA for a device called "Sci-Pharm Desensitizing Varnish." This letter indicates that the device has been found substantially equivalent to a predicate device and can be marketed. It does not contain details about performance studies, acceptance criteria, sample sizes, ground truth establishment, or expert involvement.

Therefore, I cannot fulfill your request for the detailed table and study information.

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For permanent cementation of Crowns and bridges on non-vital teeth and on vital teeth where the use of Conventional Zinc Phosphate Cements is judged appropriate.

ZinFos Zinc Phosphate Cement

The provided document is a 510(k) clearance letter for a medical device called "ZinFos Zinc Phosphate Cement." This document is not a study report and therefore does not contain the information requested in the prompt.

The prompt asks for details about acceptance criteria and a study proving device performance, typically found in a clinical or performance assessment report for a device, especially for those involving AI or diagnostic capabilities. The ZinFos Zinc Phosphate Cement is a traditional dental cement, and its regulatory clearance would be based on substantial equivalence to predicate devices, rather than a performance study as described in the prompt's questions.

Therefore, I cannot provide a table of acceptance criteria, device performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC study results, or ground truth details from the given text.

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