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Glaze used for the repair of check lines in PFMs and dental bridges.

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The provided text is a 510(k) premarket notification letter from the FDA regarding a dental product named "Denseo Fairy" (Porcelain Powder for Clinical Use). It is not a study report and therefore does not contain information about acceptance criteria, device performance, sample sizes, expert ground truth establishment, or any comparative effectiveness studies.

The letter confirms that the device is substantially equivalent to a legally marketed predicate device for its indicated use as a "Glaze used for the repair of check lines in PFMs and dental bridges" (Page 2, Indication for Use).

To address your request, I would need a different type of document, such as a clinical study report, a scientific publication, or a more detailed section of a 510(k) application that describes the performance data. This FDA letter solely communicates the regulatory decision of substantial equivalence.

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Porcelain fused to metal for dental use.

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I am sorry, but the provided text is a 510(k) summary for a dental porcelain device. It is a regulatory document from the FDA outlining the substantial equivalence determination for "Zeo CE Light and Zeo Quick Porcelain."

This document does not contain information regarding:

• Acceptance criteria and reported device performance.
• Sample sizes, data provenance, or expert qualifications for a study.
• Adjudication methods.
• Multi-reader multi-case (MRMC) comparative effectiveness studies.
• Standalone algorithm performance.
• Types of ground truth used.
• Training set sample sizes or how ground truth for training sets was established.

Therefore, I cannot provide the requested information based on the provided text. The document is strictly a regulatory approval notice and does not include the details of a performance study.

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Acrylic teeth to be used for construction of full and partial dentures by a dental professional. Dentures are removable, not implanted in patients' mouths.

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I am sorry, but the provided text does not contain the detailed information necessary to answer your request regarding acceptance criteria and a study proving device performance. The document is a 510(k) clearance letter from the FDA for a device called "Wiedent Esthetic Teeth."

This type of letter primarily focuses on:

• Substantial Equivalence: It states that the device is substantially equivalent to legally marketed predicate devices, meaning it has the same intended use and technological characteristics as a device already on the market, or if there are differences, those differences do not raise new questions of safety and effectiveness.
• Regulatory Classification: It clarifies the device's regulatory class and product code.
• Compliance Requirements: It reminds the manufacturer of their ongoing responsibilities under the Federal Food, Drug, and Cosmetic Act.

The document does not include:

• Specific acceptance criteria for the device's performance (e.g., tensile strength, wear resistance, color stability).
• Details of any performance studies conducted to meet such criteria.
• Information on sample sizes, data provenance, expert qualifications, ground truth establishment, or comparative effectiveness studies.

Therefore, I cannot populate the table or provide the requested study details from the text you provided.

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