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• Class I and II restorations in deciduous teeth
• Class I, and non-stress bearing Class II restorations in permanent teeth
• Stress bearing Class II restorations in permanent teeth, keeping ≥1 mm distance from the cusp tips

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• Anterior and posterior restorations
• Repair of restorations and prostheses
• Core-build up
• Direct laminate veneer

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The provided text is a standard FDA 510(k) clearance letter for a dental resin material, "Beautifil II." This document confirms that the device has been cleared for marketing based on its substantial equivalence to previously marketed devices.

*Crucially, this document does not contain any information about acceptance criteria or a study proving the device meets those criteria, especially in the context of an AI/ML-based medical device. The product, "Beautifil II," is a physical dental material (tooth shade resin), not an AI/ML software device.

Therefore, I cannot provide the requested information, such as:

• A table of acceptance criteria and reported device performance
• Sample sizes for test sets or data provenance
• Number of experts or their qualifications for ground truth establishment
• Adjudication methods
• MRMC study details or effect sizes
• Standalone algorithm performance
• Type of ground truth used
• Training set sample size or how its ground truth was established

The 510(k) clearance process for a material like Beautifil II typically involves different types of testing (e.g., biocompatibility, physical properties, mechanical strength, chemical composition) to demonstrate safety and effectiveness, rather than a clinical study with image-based ground truth and human reader performance evaluation as would be done for an AI/ML diagnostic aid.

If you have a document describing the testing for an AI/ML device, please provide that, and I would be happy to analyze it against your request.

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Cementation of all-ceramic, composite and metal restorations
Post cementation

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I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter for a dental cement called "BeautiLink SA." It discusses regulatory aspects, general controls, and indications for use.

It does not contain:

• A table of acceptance criteria and reported device performance.
• Details about sample sizes, data provenance, or the nature of test sets (retrospective/prospective, country of origin).
• Information on experts, ground truth establishment, or adjudication methods for any test or training sets.
• Any mention of a Multi-Reader Multi-Case (MRMC) study or the effect size of AI assistance.
• Details about standalone algorithm performance.
• Information on the training set size or how its ground truth was established.

This document is a regulatory clearance, not a study report or technical specification outlining performance metrics and supporting validation studies.

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• Restoration of deciduous teeth
• Non-load bearing Class I and Class II restorations in permanent teeth
• Restoration of Class III and Class V cavities and wedge shaped defects
• Core build-up

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I am sorry, but the provided text is a 510(k) clearance letter for a dental cement called "GlasIonomer FX ULTRA". It does not contain any information about acceptance criteria, study details, or performance of an AI/ML powered medical device. Therefore, I cannot generate the requested response.

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Fabrication of all ceramic restorations except for four- or more unit bridges including molars.

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I'm sorry, but this document does not contain the information requested in your prompt. The document is an FDA 510(k) clearance letter for a dental product called "Vintage Prime Press," which is a porcelain powder for clinical use. It outlines the regulatory clearance process and the indications for use of this device.

The document does not describe acceptance criteria for a device's performance, nor does it detail a study that proves the device meets such criteria. It discusses the regulatory path, product classification, and general controls applicable to the device.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, information about sample sizes or data provenance for a test set, details on expert roles for ground truth, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set information.

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• Direct restorations with light-cured composite resin
• Repair of fractured restorations with light-cured composite resin
• Post cementation and core build-up
• Cementation of indirect restorations with light-cured/dual-cured resin cement
• Treatment of hypersensitive teeth or exposed root surface
• Sealing of tooth preparation (cavity or abutment) for indirect restorations

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I am sorry, but the provided text does not contain any information about acceptance criteria for a device, nor does it describe a study proving the device meets those criteria.

The document is an FDA 510(k) clearance letter for a dental bonding agent named "BeautiBond Xtreme." It primarily

• Confirms the FDA's review and determination of substantial equivalence for the device.
• Outlines the general controls provisions of the Federal Food, Drug, and Cosmetic Act that apply to the device.
• Lists the indications for use of the device.

Therefore, I cannot fulfill your request to describe the acceptance criteria and a study proving the device meets them based on the provided text.

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For fabrication of inlays / onlays, laminate veneers, anterior and posterior full crown restorations and implant supported restorations, using a dental CAD / CAM system.

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This document is a 510(k) clearance letter from the FDA for a dental material (Shofu Block HC Hard), not an AI/ML device. Therefore, the requested information about acceptance criteria and studies proving the device meets them, particularly concerning AI/ML performance metrics, ground truth, sample sizes, and expert adjudication, is not applicable to this document.

The document discusses the regulatory clearance process for a tooth shade resin material under the name "Shofu Block HC Hard" and confirms its substantial equivalence to predicate devices. It outlines general regulatory requirements for medical devices but does not include any performance data or study details that would typically be associated with AI/ML device evaluations.

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Shade adjustment of ceramic restorations

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I am sorry, but the provided text from the FDA letter (K191794) for "Vintage Art Universal" does not contain information about the acceptance criteria or a study proving the device meets those criteria.

The document is a 510(k) clearance letter for a dental porcelain powder, classifying it as a Class II device. It primarily discusses:

• The FDA's determination of substantial equivalence to predicate devices.
• Regulatory requirements and general controls (registration, listing, GMP, labeling, adverse event reporting).
• The intended use of the device: "Shade adjustment of ceramic restorations."

There is no mention of:

• Specific performance metrics or acceptance criteria (e.g., sensitivity, specificity, accuracy for a diagnostic device).
• Details of a clinical study or performance study, including sample sizes, data provenance, ground truth establishment, expert qualifications, or adjudication methods.
• Any information regarding AI/human reader performance or MRMC studies.

Therefore, I cannot provide the requested table or answer the specific questions about acceptance criteria and study details based on the provided text. This type of information is typically found in the 510(k) summary or the full submission, not in the clearance letter itself unless specifically highlighted for a novel device or testing paradigm.

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