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Silverfil amalgam is used by dental professionals to fill tooth cavities. It is used in the same way as other amalgams used in the world today. Its usage and handling techniques are the same as other amalgams.

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This document is a 510(k) premarket notification decision letter from the FDA for a dental amalgam alloy. It does not contain information about acceptance criteria or a study proving device performance against such criteria. The document is primarily focused on the declaration of "substantial equivalence" to a predicate device, which is a regulatory pathway for certain medical devices.

Therefore, I cannot provide the requested information as it is not present in the provided text.

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The intended use for SECURALLOY dental amalgam is the filling cavities in posterior teeth (class I and class II restorations) and core build-up.
The intended use for SEPTALLOY NG 70 dental amalgam is the filling cavities in posterior teeth (class I and class II restorations) and core build-up.
The intended use for SEPTALLOY NG 50 dental amalgam is the filling cavities in posterior teeth (class I and class II restorations) and core build-up.

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This document is a 510(k) premarket notification decision letter from the FDA for dental amalgam devices. It does not contain information about acceptance criteria or a study proving that a device meets such criteria. Therefore, I cannot extract the requested information from the provided text.

The document states that the devices (Securalloy, Septalloy NG 50, and Septalloy NG 70) are "substantially equivalent" to legally marketed predicate devices, which is the basis for their clearance. It does not describe performance acceptance criteria or a study with specific metrics, sample sizes, or ground truth methodologies as would be expected for a detailed performance evaluation.

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This is a dental amalgam for the filling of tooth cavities of Black's Classes I and II.

Bestaloy is used as a filling material for restoring function to teeth that have lost portions to caries.

The provided text describes a 510(k) premarket notification for a dental amalgam called "Bestaloy." It states that Bestaloy has undergone safety, performance, and product validations and that it has the same device characteristics as its predicate device (LUXALLOY™, DEGUSSA AG K902249). However, it does not provide specific details about acceptance criteria or a study proving that the device meets those criteria with quantitative performance metrics.

Therefore, I cannot extract the detailed information requested in your prompt regarding acceptance criteria, reported performance, sample sizes, ground truth establishment, expert qualifications, or MRMC studies. The submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed quantitative results.

Here's what can be inferred from the provided text, but it falls short of your specific requirements:

1. Table of Acceptance Criteria and Reported Device Performance: Not available in the provided text. The submission states, "Bestaloy has been subjected to extensive safety, performance, and product validations prior to release. Safety tests have been performed to ensure the devices comply to applicable industry and US requiations." However, it does not list specific criteria or quantitative performance results.

2. Sample Size Used for the Test Set and Data Provenance: Not mentioned in the provided text.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications: Not mentioned in the provided text.

4. Adjudication Method for the Test Set: Not mentioned in the provided text.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size: Not mentioned in the provided text. This type of study is generally not typical for a dental amalgam 510(k) submission, which focuses on material equivalence.

6. If a Standalone (algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a dental material, not an algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.): Not mentioned in the provided text. The submission relies on "device characteristics" being the same as the predicate.

8. The Sample Size for the Training Set: Not mentioned in the provided text. (Training sets are typically for AI/ML models, which this device is not).

9. How the Ground Truth for the Training Set was Established: Not applicable as this is a dental material.

Summary of what is available from the text:

• Device Name: Bestaloy
• Predicate Device: LUXALLOY™, DEGUSSA AG K902249 (K902249)
• Basis for Equivalence: "Bestaloy has the same device characteristics as the predicate device. Material, design and use concept is similar."
• Testing Conducted: "extensive safety, performance, and product validations" and "Safety tests have been performed to ensure the devices comply to applicable industry and US requiations."
• Conclusion: The manufacturer concludes that Bestaloy is "safe and effective and substantially equivalent to predicate devices."

The document is a 510(k) clearance letter, which confirms that the FDA found the device substantially equivalent to a predicate. It does not contain the detailed performance study results that would be part of a submission to demonstrate performance against specific acceptance criteria.

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Silver based alloy dental restorative used in all classes of restorations.

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The provided text is a 510(k) clearance letter from the FDA for a dental alloy. It does not contain information about acceptance criteria or a study proving that a device meets such criteria. Specifically:

1. Acceptance criteria and reported device performance: Not present. This document is a regulatory clearance, not a performance report.
2. Sample size, data provenance: Not present.
3. Number of experts and qualifications: Not present.
4. Adjudication method: Not present.
5. MRMC comparative effectiveness study: Not present.
6. Standalone performance study: Not present.
7. Type of ground truth: Not present.
8. Sample size for training set: Not present.
9. How ground truth for training set was established: Not present.

The document discusses the regulatory determination of substantial equivalence for the "Benco Admix" dental restorative, indicating it's an amalgam alloy used in all classes of restorations. It refers to general controls and existing regulations but does not detail any performance studies or their associated acceptance criteria.

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Silver based alloy dental restorative used in all classes of restorations.

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The provided text is a 510(k) premarket notification letter from the FDA regarding a dental restorative material, "Benco Spherical." This document confirms the device's substantial equivalence to a predicate device and permits its marketing. It does not contain information about acceptance criteria, device performance studies, or details relevant to the specific questions posed (sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details). These types of details are typically found in the 510(k) submission itself, which is not provided here, rather than in the FDA's decision letter.

Therefore, I cannot provide the requested information based solely on the provided text. The document is a regulatory approval letter, not a technical report on device performance.

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HIGH SILVER CONVENTIONAL is to be used as a filling material for restoring function to teeth which have lost portions to caries:

Direct, fixed restorations, placed by the dentist after removal of carious tissue.

Single surface cavities such as Class I

Two surface cavities such as MO, DO, FO, LO

Three surface cavities such as MOD, FOD.

Pinned onlays and half crowns.

Core build-ups for cast half and full crowns.

For use only by dental professional such as DDS or DMD. Not for use by general public or OTC.

HIGH SILVER CONVENTIONAL

I am sorry, but the provided text does not contain the acceptance criteria or a study that proves the device meets specific acceptance criteria in the format you requested. The document is a 510(k) premarket notification letter from the FDA to AB Ardent regarding their "High Silver Conventional" amalgam alloy.

The letter confirms that the device is substantially equivalent to legally marketed predicate devices and outlines general regulatory requirements. It also includes an "Indications for Use" section for the device. However, it does not detail specific performance metrics, acceptance criteria, or a study methodology that would allow me to populate the table and answer the study-related questions.

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FUTURA TOPCAP non gamma-2 is to be used as a filling material for restoring function to teeth which have lost portions to caries:

Direct, fixed restorations, placed by the dentist after removal of carious tissue.

Single surface cavities such as Class I

Two surface cavities such as MO, DO, FO, LO

Three surface cavities such as MOD, FOD.

Pinned onlays and half crowns.

Core build-ups for cast half and full crowns.

For use only by dental professional such as DDS or DMD. Not for use by general public or OTC.

Labels will bear this caution.

Not Found

This document is a 510(k) clearance letter from the FDA for a dental filling material called "Futura Topcap Non Gamma-2". It does not contain information about the acceptance criteria or a study proving the device meets acceptance criteria. The letter primarily states that the device is substantially equivalent to legally marketed predicate devices and outlines general regulatory information and indications for use. Therefore, I cannot extract the requested information from the provided text.

Ask a specific question about this device

Ask a specific question about this device

Ask a specific question about this device

Ask a specific question about this device