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DMRC Nanoflow and DMRC Nanocomposite are designed for use in all classes of cavities. DMRC Nanoflow is a low viscosity composite and DMRC Nanocomposite is a universal viscosity composite.

DMRC Nanoflow and DMRC Nanocomposite

The provided FDA 510(k) document for DMRC NanoFlow and DMRC NanoComposite is primarily a clearance letter, confirming the substantial equivalence of the device to existing products. It does not contain the detailed study information or acceptance criteria typical for a device's performance evaluation as envisioned by the provided prompt.

Therefore, I cannot extract the required information about acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment directly from the text provided.

The document only states that the device is "substantially equivalent" to legally marketed predicate devices for the indicated uses. The indications for use are: "DMRC Nanoflow and DMRC Nanocomposite are intended to be used in all classes of cavities." It further describes DMRC Nanoflow as a "low viscosity composite" and DMRC Nanocomposite as having "cannot viseosity" (likely a typo, perhaps meaning "nano-viscosity" or similar, or referring to a non-low viscosity).

Therefore, I cannot fulfill the request to complete the table and answer the specific questions about the study design and acceptance criteria based on this document.

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Z Bond and Prelude One are a Primer and adhesive used for:

• Conditioning of zirconia, alumina, and metal definitive restorations prior to cementation, . e.g., crowns, posts, inlays, and onlays.
• Adhesive repair of defects in zirconia, alumina, metal and composite restorations . currently affixed to a patient's dentition.
• . Adhesive for bonding composites and other dental restorative materials to enamel or dentin.

Not Found

I am sorry, but the provided text is a 510(k) premarket notification letter and "Indications for Use Form" from the FDA concerning dental bonding agents (Z Bond and Prelude One).

It does not contain information about:

• Acceptance criteria for a device performance study.
• Details of a study proving device meets acceptance criteria (experimental design, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, training set details).

Therefore, I cannot fulfill your request based on the provided text.

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Silver system is a system used to The and repair cerainic and intettil oond Vestoration S dental

SilJet System

I am sorry, but the provided text does not contain the detailed information necessary to describe the acceptance criteria and the study that proves the device meets those criteria. The document is primarily a letter from the FDA regarding a 510(k) premarket notification for the "SilJet System" device, indicating substantial equivalence to predicate devices. It discusses regulatory requirements but does not include:

• A table of acceptance criteria and reported device performance.
• Details about sample sizes, data provenance, or ground truth establishment for test or training sets.
• Information on expert qualifications, adjudication methods, or MRMC studies.
• Results from standalone algorithm performance tests.

The document states the "Indications for Use" for the SilJet System, which is "a system used to repair ceramic and indirectly bonded dental restorations." However, it does not provide the specific performance metrics or study details to support this indication.

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Turbo Temp 3 is a syringe able acrylic provisional composite used for temporary crown and bridge placement.

Turbo Temp 3 is a syringe able acrylic provisional composite used for temporary crown and bridge placement.

I am sorry, but the provided text from the FDA letter regarding K102753 does not contain information about acceptance criteria, device performance results, study details (sample sizes, ground truth establishment, expert qualifications, adjudication methods), or any information about AI or MRMC studies.

The document is a 510(k) clearance letter for a temporary crown and bridge material called "Turbo Temp 3," indicating it has been found substantially equivalent to a legally marketed predicate device. It specifies the product name, regulation number, regulation name, regulatory class, and product code, along with general regulatory information and contact details.

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

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StarFill 2B HV and LV are dual-cure (auto-cure with light-cure acceleration) polymer-based dental restoratives that when applied to dental surfaces pretreated with suitable primers or adhesives are indicated for use as the first increment under posterior composites; for core buildups; and for luting posts, crowns, veneers and any application where light transmission may be inadequate.

dual-cure (auto-cure with light-cure acceleration) polymer-based dental restoratives

This document is a 510(k) clearance letter from the FDA for a dental restorative material, Starfill 2B HV and LV. It does not contain information about acceptance criteria or a study proving that a device meets such criteria because it pertains to a material, not an AI/ML powered device. Therefore, I cannot extract the requested information from this text.

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The device is an additional-cure viny| polysiloxane dental impression material that is used for all crown and bridges, edentulous and Implant techniques.

Not Found

The provided text is a letter from the FDA regarding a 510(k) premarket notification for a dental impression material named "Star VPS, First Half, First Quarter." This document is a regulatory approval letter, not a study report or clinical trial result.

Therefore, the requested information about acceptance criteria, device performance, study details (sample sizes, provenance, ground truth, experts, adjudication, MRMC, standalone performance, training set) cannot be extracted from this document, as it does not contain such information.

The document primarily states that the FDA has reviewed the 510(k) and determined the device is substantially equivalent to legally marketed predicate devices for the indicated uses. The indications for use are provided: "The device is an additional-cure vinyl polysiloxane dental impression material that is used for all crown and bridges, edentulous and Implant techniques."

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Prelude One is a light cured adhesive designed for direct restorations, i.e. composites and compomers to enamel and/or dentin, composite repairs, porcelain repairs and post and core build-up materials, and indirect restorations such as veneers, onlays, inlays, crowns and bridges.

Prelude One is a dental bonding agent used to restore all classes of cavities

The provided text does not contain information about the acceptance criteria or a study proving that the device meets those criteria. The document is a 510(k) summary for a dental bonding agent (Prelude One) and primarily focuses on its substantial equivalence to predicate devices, intended use, and regulatory classification. It does not include details about device performance tests, clinical studies, or specific acceptance criteria.

Therefore, I cannot provide the requested information in the table or answer the specific questions about studies, sample sizes, ground truth establishment, or expert involvement, as this information is not present in the provided text.

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Prelude is a light cured adhesive designed for direct restorations, i.e. composites and compomers to enamel and/or dentin, composite repairs, porcelain repairs and post and core build-up materials, and indirect restorations such as veneers, onlays, inlays, crowns and bridges. When used with Prelude Activator, Prelude may also be used with self or dual cure materials.

Prelude is a dental bonding agent used to restore all classes of cavities.

The provided document is a 510(k) summary for a dental bonding agent called "Prelude" and does not contain the detailed study information typically found in acceptance criteria and performance reports for medical devices, particularly those involving AI or complex performance metrics. The document focuses on establishing substantial equivalence to predicate devices for regulatory clearance.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor can I answer questions 2 through 9 based on the information given. This type of regulatory submission for a dental bonding agent does not involve clinical studies with human readers, ground truth analysis, or AI performance metrics as would be seen for imaging or diagnostic AI devices.

The document mainly covers:

• Device Name: Prelude
• Applicant: Danville Materials, Inc.
• Contact Person: Craig R. Bruns
• Date of Summary: March 12, 2004
• Device Description: A dental bonding agent used to restore all classes of cavities.
• Predicate Devices: Optibond Solo Plus and Optibond Solo Plus 4 (K990498 & K014027), Clearfil SE (K990040), and Optibond Solo Plus Activator (K012082).
• Intended Use/Indications for Use: Light cured adhesive for direct restorations (composites and compomers to enamel/dentin, composite repairs, porcelain repairs, post and core build-up materials) and indirect restorations (veneers, onlays, inlays, crowns, bridges). Can be used with self or dual cure materials when combined with Prelude Activator.

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The PrepAir is intended for the cutting and preparation of all classes of cavity restorations; removal of composite resin fillings; surface roughening of enamel, dentin, metals and composite surfaces prior to adhesive resin bonding; preparation of pits and fissures prior to sealing; cleaning and removal of cements and adhesives from bridges and crowns prior to re-cementation; and preparation of adhesive surfaces of orthodontic bands and brackets to increase retention.

The PrepAir is a dental airbrush using aluminum oxide to prepare all classes of cavity prior to restoration.

This document is a 510(k) Summary of Safety and Effectiveness for a dental airbrush device called PrepAir. It primarily focuses on demonstrating substantial equivalence to previously marketed predicate devices, rather than presenting a study with specific acceptance criteria and performance data in the format requested.

Therefore, many of the requested sections cannot be directly extracted from the provided text as they relate to a different type of study (e.g., performance testing with acceptance criteria, human reader studies, or detailed ground truth establishment), which is not present in this 510(k) submission.

Here's an analysis based on the information available in the document, noting what cannot be provided:

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

This information is not present in the provided 510(k) summary. The document focuses on demonstrating substantial equivalence based on intended use, device description, and comparison to predicate devices, rather than presenting a performance study against specific, quantified acceptance criteria.

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

This information is not present. No specific test set or data provenance is detailed for performance evaluation, as the submission relies on substantial equivalence to predicate devices.

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)

This information is not present. There is no ground truth establishment described for a test set in this document.

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

This information is not present. No test set or adjudication method is described.

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

This information is not present. This device is a physical dental airbrush, not an AI or imaging diagnostic tool. Therefore, an MRMC study or AI assistance is not applicable.

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

This information is not present. This device is a physical tool, not an algorithm.

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

This information is not present. Ground truth is not relevant in the context of this 510(k) submission, which focuses on substantial equivalence for a physical device.

8. The sample size for the training set

This information is not present. No training set is mentioned as this is not an AI/algorithm-based device.

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

This information is not present. Ground truth for a training set is not applicable here.

Summary of what is available from the document:

• Device Name: PrepAir
• Intended Use: For cutting and preparation of all classes of cavity restorations; removal of composite resin fillings; surface roughening of enamel, dentin, metals, and composite surfaces prior to adhesive resin bonding; preparation of pits and fissures prior to sealing; cleaning and removal of cements and adhesives from bridges and crowns prior to re-cementation; and preparation of adhesive surfaces of orthodontic bands and brackets to increase retention.
• Predicate Devices: PrepStart by Danville Engineering (K970589), PrepTech by Prep Technology Corp (K974655), AirDent by Air Techniques (K981564), and Rondoflex by Kavo America (K002708).
• Regulatory Conclusion: The FDA determined the device is "substantially equivalent" to legally marketed predicate devices, meaning it meets the requirements for marketing without a full Pre-Market Approval (PMA) application, based on its similarity in intended use and technological characteristics to devices already on the market.

Conclusion:

The provided document is a 510(k) summary, which is a premarket submission to FDA to demonstrate that a device is "substantially equivalent" to a legally marketed predicate device. This process typically focuses on comparing the new device's intended use, technological characteristics, and safety/effectiveness data to a predicate, rather than detailing a specific study with quantitative acceptance criteria and performance metrics unique to the new device in the way requested for an AI/algorithm-based product. Therefore, the information requested regarding acceptance criteria, sample sizes, expert ground truth, and study design is not contained within this specific type of regulatory document.

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Starflow HV is intended for use for the restoration of Class III, Class IV, and Class V cavities, small Class I cavities not in occlusion, repair of enamel defects, repair of porcelain restorations, minor occusal build-ups in non-stress bearing areas, pit and fissure sealant, cement for seramic/composite veneers, incisal abrasions, and core build-ups.

Starflow HV is a light-cured, hybrid dental retorative which incorporates BIS/GMA resin along with Barium aluminosilicate glass filler (64% by wt) to yield a flowable dental restorative.

The provided text is a 510(k) summary for the Starflow HV device, which is a dental restorative material. This type of regulatory submission focuses on demonstrating substantial equivalence to pre-existing devices rather than independent clinical studies with specific acceptance criteria and detailed performance metrics.

Therefore, the document does not contain the information requested regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.

The 510(k) summary describes the device, its intended use, and identifies predicate devices (Revolution by Sybron Dental Specialties (K013647), StarFlow by Danville Materials Inc (K990108), and Tetric Flow (K 993783) by Ivoclar Vivadent) to which it claims substantial equivalence. The primary difference noted is "very minor changes to the material composition."

To address the specific points of your request:

1. A table of acceptance criteria and the reported device performance: Not present. The submission focuses on substantial equivalence based on material composition and intended use, not on specific performance metrics with predefined acceptance criteria.
2. Sample size used for the test set and the data provenance: Not present. No test set or associated data is described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present. No ground truth establishment for a test set is mentioned.
4. Adjudication method: Not present.
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: Not applicable. This device is a dental restorative material, 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 is not an algorithmic device.
7. The type of ground truth used: Not applicable for a performance study. For regulatory purposes, the "ground truth" for substantial equivalence is demonstrating that the new device is as safe and effective as a legally marketed predecessor.
8. The sample size for the training set: Not applicable. No training set for an algorithm is mentioned.
9. How the ground truth for the training set was established: Not applicable.

In conclusion, this 510(k) submission does not provide the kind of detailed study information (acceptance criteria, performance data, specific study design, expert involvement) that would be found in a clinical trial report or a submission for a novel, high-risk device. The regulatory pathway chosen for Starflow HV relies on demonstrating that it is fundamentally similar to existing, legally marketed dental restorative materials.

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