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Found 4 results
510(k) Data Aggregation
(37 days)
Porcelain - to - metal restorations
Not Found
The provided text is a 510(k) premarket notification letter from the FDA regarding a dental device called "XeraFit." This document does not contain any information about acceptance criteria or a study that proves the device meets acceptance criteria.
The letter is a regulatory approval document confirming that the device is substantially equivalent to legally marketed predicate devices. It discusses:
- Device Name: XeraFit
- Regulation Number and Name: 872.3710, Base Metal Alloy
- Product Code: EJH
- Intended Use: Porcelain-to-metal restorations
- Regulatory Class: II
The document focuses on the administrative aspects of FDA clearance, such as substantial equivalence, regulatory compliance, and contact information for further inquiries. It does not include technical specifications, performance metrics, study designs, or results from any performance testing.
Therefore, I cannot provide the requested information from this document.
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(70 days)
Substructures for porcelain-to-metal crowns and bridges. Suprastructures on implants, milling works."""
Not Found
The provided text is a 510(k) premarket notification letter from the FDA to Metalor Technologies USA Dental Division regarding their device, V-Gnathos Supra. This document primarily focuses on the regulatory approval process and does not contain information about acceptance criteria or a study that proves the device meets those criteria.
Therefore, I cannot provide the requested information based on the given input. The document is a regulatory approval letter, not a study report.
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(73 days)
Conventional crown and bridge, inlays, onlays, milling work, cast partial denture-frames.
Not Found
I am sorry, but the provided text does not contain information about acceptance criteria, the results of a study, or any details related to device performance in the context of a clinical or analytical study. The document is an FDA 510(k) clearance letter for a dental device named "Yellow Special," indicating that it has been found substantially equivalent to a predicate device. It lists the device name, regulation number, product code, and indications for use, but no performance data, study design, or acceptance criteria are discussed.
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(58 days)
Low fusing ceramic crowns, small bridges, inlays, onlays
Not Found
The provided text is a 510(k) clearance letter from the FDA for a dental alloy named "Aurofluid Plus". It confirms that the device is substantially equivalent to legally marketed predicate devices.
However, this document does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, or MRMC/standalone studies traditionally associated with AI/ML medical devices.
The information requested in your prompt (e.g., acceptance criteria, study details, expert consensus, training sets) is typically found in a device's 510(k) summary, clinical study reports, or performance testing documentation, not in the FDA clearance letter itself.
Therefore, I cannot fulfill your request with the input provided. The document is a regulatory approval, not a technical performance report.
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