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Hy-Bond Resiglass is intended for cementation of restorations (including inlay, crown and bridge) made of metal, ceramics (porcelain) and resin to natural teeth. This product is also intended for cementation of orthodontic appliances (metal bracket, ceramics bracket, etc.) to natural teeth.

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The provided document is a 510(k) premarket notification letter from the FDA regarding a dental cement called "Hy-Bond Resiglass." 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, multi-reader multi-case studies, standalone performance, or ground truth establishment.

Therefore, most of the requested information cannot be extracted from this document.

Here's a breakdown of what can be inferred or stated based on the document:

1. A table of acceptance criteria and the reported device performance:

   • Cannot be provided. This document does not list any specific acceptance criteria or performance metrics for the device. The FDA's determination is based on substantial equivalence to predicate devices, not on the demonstration of meeting specific performance criteria detailed here.

2. Sample size used for the test set and the data provenance:

   • Cannot be provided. The document does not describe any test sets or studies performed by the manufacturer to establish performance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Cannot be provided. The document does not describe any test sets or expert involvement in establishing ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Cannot be provided. The document does not describe any test sets or adjudication methods.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • No MRMC study was done, nor is this an AI device. This device is a dental cement, not an AI-powered diagnostic or assistive tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

   • Not applicable. This device is a dental cement, not an algorithm, so the concept of standalone performance does not apply.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • Cannot be provided. The document does not describe any ground truth establishment for performance testing. Substantial equivalence for this type of device typically relies on demonstrating similar physical and chemical properties and intended use to existing marketed devices.

8. The sample size for the training set:

   • Cannot be provided. The document does not describe any training sets.

9. How the ground truth for the training set was established:

   • Cannot be provided. The document does not describe any training sets or ground truth establishment for them.

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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.

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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.

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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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LITE ART is dental resin-based stain material intended to harmonize the color of polymer-based C&B composite resin restorations with surrounding natural dentition. Specific usage of this product is as follows: 1) To characterize and modify C&B composite resin or acrylic resin restorations and 2) To characterize and modify hard resin teeth and acrylic resin teeth.

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This letter is a 510(k) clearance for a dental resin material named "Lite Art." It confirms that the device is substantially equivalent to legally marketed predicate devices. However, the document does not contain the acceptance criteria or a study proving the device meets those criteria.

Therefore, I cannot extract the requested information. The document focuses on regulatory clearance based on substantial equivalence, not on performance studies with specific acceptance criteria.

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Beautifil Flow Plus is a light-curing dental filling material having low viscosity intended to directly restore cavities and lesions (except for root canal filling), and to repair fractured artificial crowns.

Beautifil Flow Plus is a light-curing dental filling material having low viscosity.

This document is a 510(k) premarket notification for a dental filling material, Beautifil Flow Plus. It is a letter from the FDA confirming substantial equivalence to a predicate device. This type of document, particularly for a dental filling material, is unlikely to contain information about acceptance criteria and a study proving device performance in the way requested for software or AI-based medical devices.

Medical devices like dental fillings are typically evaluated based on material properties, biocompatibility, and clinical performance through different types of studies (e.g., in vitro, in vivo, clinical trials for safety and effectiveness). The acceptance criteria would relate to these aspects rather than metrics like sensitivity/specificity for diagnostic devices.

Therefore, most of the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of diagnostic performance (e.g., sample size for test sets, expert ground truth, MRMC studies) will not be present in this FDA letter for a dental filling material.

Let's break down what can be inferred or stated based on the provided text, and what cannot.

1. A table of acceptance criteria and the reported device performance

• Cannot be provided from this document. This document is an FDA clearance letter confirming substantial equivalence, not a detailed study report. It does not contain a table of acceptance criteria or performance metrics for diagnostic accuracy. For a dental filling material, acceptance criteria would typically involve physical properties (e.g., compressive strength, wear resistance), chemical properties (e.g., leachables), and biocompatibility.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Cannot be provided from this document. This information pertains to a performance study for diagnostic AI/software, which is not relevant to this type of device and document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Cannot be provided from this document. This is not applicable to a dental filling material.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Cannot be provided from this document. This is not applicable to a dental filling material.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Cannot be provided from this document. This type of study is for diagnostic devices with AI assistance, not for a dental filling material.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Cannot be provided from this document. This is not applicable to a dental filling material.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

• Cannot be provided from this document. This is not applicable to a dental filling material.

8. The sample size for the training set

• Cannot be provided from this document. This information is for AI/machine learning models, not for a dental filling material.

9. How the ground truth for the training set was established

• Cannot be provided from this document. This information is for AI/machine learning models, not for a dental filling material.

Summary based on the document:

The provided document is an FDA 510(k) clearance letter for a dental filling device, "Beautifil Flow Plus." The letter states that the FDA "reviewed your Section 510(k) premarket notification of intent to market the device... and have determined the device is substantially equivalent... to legally marketed predicate devices."

This document confirms regulatory clearance based on substantial equivalence, but it does not contain the detailed technical study information (acceptance criteria, performance metrics, sample sizes for diagnostic accuracy studies, expert ground truth, etc.) that would typically be part of a submission for an AI-powered diagnostic device. The evaluation for a dental filling material would focus on material properties, biocompatibility, and clinical safety and effectiveness data (often comparing to a predicate device), which are not detailed in this specific FDA clearance letter.

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VINTAGE MP is paste or powder porcelain intended to fabricate metal-ceramic restorations. It is used in conjunction with precious alloys for metal-ceramic restoration, metals for metal-ceramic restoration and stain materials for metalceramic restoration in order to produce natural looking restorations and prostheses.

VINTAGE MP is paste or powder porcelain

This document is an FDA 510(k) clearance letter for a dental porcelain product, "Vintage MP." It is not a study report and therefore does not contain the information requested regarding acceptance criteria and device performance studies.

The letter simply states that the FDA has reviewed the premarket notification and determined the device is "substantially equivalent" to legally marketed predicate devices. It outlines regulatory requirements for marketing the device but does not include any performance data or study details.

To answer your questions, one would need to refer to the actual 510(k) submission document, which is not provided here.

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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.

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RESICEM is a dual cured, visible light cured, and self cured dental adhesive resin cement and is intended for adhesion between any two of the following: dental restoration, dental restorative material, dental device, and natural teeth.

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This document is a 510(k) premarket notification letter from the FDA for a dental cement called ResiCem. It determines that the device is substantially equivalent to legally marketed predicate devices and therefore can be marketed.

The document does not contain information about:

• Acceptance criteria and reported device performance: While it states the device is "substantially equivalent," it does not provide specific performance metrics or acceptance criteria used to reach this conclusion.
• Study details: There is no mention of any specific studies, sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies. This type of detailed study information is not typically included in the 510(k) clearance letter itself, but rather in the full 510(k) submission which is not provided here.

Therefore, I cannot provide the requested table or answer the specific questions about the study from the provided text. The document is essentially an approval letter, not a scientific study report.

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Vintage Art is dental ceramic stain and is used for adjusting the shade of dental ceramic restorations or prostheses. It can reproduce natural-teeth like crown restorations and prostheses when built up on dental metal ceramic porcelain, dental porcelain, dental ceramic core material and porcelain teeth.

Vintage Art is dental ceramic stain.

I am sorry, but the context provided does not contain the information requested. The document is an FDA 510(k) clearance letter for a dental ceramic product called "Vintage Art." It confirms that the device is substantially equivalent to legally marketed predicate devices.

The document discusses:

• Device Name: Vintage Art
• Regulation Number/Name: 872.6660 / Porcelain Powder for Clinical Use
• Regulatory Class: II
• Product Code: EIH
• Indications for Use: Dental ceramic stain for adjusting the shade of dental ceramic restorations or prostheses.

However, the provided text does not contain any information regarding acceptance criteria or the details of a study that proves the device meets such criteria. Therefore, I cannot generate the requested table or answer the specific questions about sample sizes, ground truth, expert qualifications, or MRMC studies.

Ask a specific question about this device

Ask a specific question about this device