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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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• Direct restorations with light-cured composite resin
• Repairs of fractured restorations with light-cured composite resin
• Cementation of indirect restorations with light- or dual-cured resin cement
• Core build-up with light- or dual-cured core materials

Not Found

The provided text is related to an FDA 510(k) clearance for a dental bonding agent called "BeautiBond Universal". It does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

The document states:

• Trade/Device Name: BeautiBond Universal
• Regulation Number: 21 CFR 872.3200
• Regulation Name: Resin Tooth Bonding Agent
• Regulatory Class: Class II

The FDA's 510(k) clearance process focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific performance acceptance criteria through the kind of study detailed in the request. For a Class II device like this bonding agent, substantial equivalence is typically established by comparing the device's technological characteristics and performance data to that of a predicate device. This usually involves bench testing (e.g., bond strength, cytotoxicity, biocompatibility) rather than studies with expert readers, AI, or ground truth as described in the prompt.

Therefore, I cannot provide the requested information based on the given text. The text does not detail:

• Acceptance criteria table or reported device performance against such criteria.
• Sample sizes for test sets or data provenance.
• Number/qualifications of experts for ground truth.
• Adjudication methods.
• MRMC comparative effectiveness study or effect sizes of human readers with/without AI.
• Standalone algorithm performance.
• Type of ground truth used.
• Sample size for training set.
• How ground truth for the training set was established.

This is a regulatory clearance document for a physical medical device, not a software or AI-powered device, hence the absence of such information.

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BeautiBond Multi PR Plus is dental adhesive to ceramic, consisting primarily of surface treatment material (silane coupling agent). This product is intended for bonding composite resin to ceramics other than alumina and zirconia or composite resin to repair fractured restorations or prostheses.

Not Found

The provided document is a 510(k) premarket notification letter from the FDA for a dental bonding agent, BeautiBond Multi PR Plus. It does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications as it is a regulatory approval document and not a scientific study report.

Therefore, I cannot extract the requested information from this document.

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BeautiBond Multi is intended for bonding composite resin to cavity or lesion including dentin. It is also intended for bonding composite resin to ceramics, composite resin, and metals to repair fractured restorations or prostheses.

Not Found

I am sorry, but the provided document is an FDA 510(k) clearance letter for a dental bonding agent (BeautiBond Multi). It confirms that the device is substantially equivalent to legally marketed predicate devices.

This type of document does not contain the detailed study information, acceptance criteria, or performance data that your request asks for. This information (like sample sizes, expert qualifications, adjudication methods, ground truth, etc.) would typically be found in the actual 510(k) submission summary or a scientific publication related to the device.

Therefore, I cannot provide the requested table and study details based on the given text.

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BeautiBond is a light-cured single-component dental adhesive intended to bond dental filling material to cavity or lesion including dentin or enamel for filling restorations of both anterior and posterior teeth.

BeautiBond is a light-cured single-component dental adhesive.

The provided text is a 510(k) premarket notification letter from the FDA regarding a dental adhesive named "BeautiBond." It confirms the device is substantially equivalent to legally marketed predicate devices and outlines regulatory compliance.

However, the document does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone algorithm performance, or ground truth establishment.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance or other details of a study based on the provided text. The document is solely an FDA clearance letter, not a study report.

Ask a specific question about this device