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• Base under Class I and II direct restorations
• Liner under direct restorative materials
• Class III and V restorations
• Undercut Blockout
• Minimally invasive cavities (including small non stress-bearing occlusal restorations)
• Tunnel preparations
• Repair of small enamel defects
• Repair of small defects in esthetic indirect restorations
• Repair of resin and acrylic temporary materials

The new Bulk Fill Flowable Composite manufactured by Septodont Louisville is a low viscosity, radiopaque flowable composite which sets upon exposure to a high-intensity blue light source. After polymerization, it exhibits low stress on the bond with the tooth, and it has a high polymerization conversion. This high degree of polymerization is achieved with short curing times and creates improved physical and mechanical properties. The new Bulk Fill Flowable Composite is packaged in single dose capsules and syringes. The shades offered with Bulk Fill Flowable Composite are: A1, A2, A3, A3.5.

The provided text is a 510(k) summary for a dental device, "Bulk Fill Flowable Composite." This type of document is for regulatory clearance and focuses on demonstrating substantial equivalence to predicate devices based on indications for use, technological characteristics, and performance data from bench tests. It is not a study that proves the device meets specific acceptance criteria in the context of an AI/ML medical device.

Therefore, I cannot extract the requested information (acceptance criteria table, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth details) because this document does not describe such a study for an AI/ML device.

Instead, the document focuses on:

1. Bench testing: Physical tests conducted according to ISO 4049:2009 for properties like Depth of Cure, Conversion, Compressive Strength, Diametral Tensile Strength, Microhardness, Volume Shrinkage Stress, Water Absorption, and Solubility.
2. Biocompatibility testing: Following ISO 10993-1:2009 and ISO 7405:2008.
3. Comparison to predicate devices: Demonstrating similar indications for use and technological characteristics.

Here's a summary of what information is available related to performance and testing, but it does not fit the requested format for an AI/ML device study:

1. Table of Acceptance Criteria and Reported Device Performance: This document does not provide a table of acceptance criteria or specific numerical performance results for the listed physical tests. It only states that the device "was tested following" the ISO standards and that the data "evaluate the performance... in comparison with its predicates." The conclusion is that the device is "substantially equivalent" and "biocompatible and safe for its intended use."

2. Sample size used for the test set and the data provenance: Not applicable in the context of an AI/ML device test set. The document refers to "bench testing" of the "Bulk Fill Flowable Composite" itself. No specific sample sizes for these bench tests are mentioned, nor is data provenance in the sense of patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically understood for AI/ML performance evaluation (e.g., expert labels on images) is not relevant to this bench testing.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.

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 material, not an AI/ML diagnostic or assistive tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the physical properties, the "ground truth" would be the standard scientific measurements themselves as defined by the ISO 4049:2009 standard. For biocompatibility, it would be the results against the criteria in ISO 10993-1:2009 and ISO 7405:2008.

8. The sample size for the training set: Not applicable. This device is not an AI/ML model that requires training data.

9. How the ground truth for the training set was established: Not applicable.

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BioRoot™ RCS is intended to be used for permanent root canal filling in combination with gutta-percha points in vital or necrotic pulp cases or after a retreatment procedure. BioRoot™ RCS is suitable for use in single cone technique or cold lateral condensation and is reserved for professional dental use only.

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I am sorry, but based on the provided text, there is no information about acceptance criteria, a study proving device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth details. The document is an FDA 510(k) clearance letter for the BioRoot™ RCS device, which confirms its substantial equivalence to a predicate device and lists its intended uses. It does not contain pre-market study data or performance metrics.

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Microhybrid Composite is indicated for direct esthetic restoration in the anterior and posterior regions. This composite can be used in all direct dental restorations, Class i, II, III, IV, and V, and diastema closure.

Microhybrid Composite

The provided text is a 510(k) premarket notification letter from the FDA for a dental device called "Microhybrid Composite." It discusses the regulatory approval process and general compliance requirements. However, this document does not contain the specific information requested about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or human-in-the-loop performance.

The letter states that the device is "substantially equivalent" to legally marketed predicate devices, meaning it has similar indications for use and technological characteristics to devices already on the market. This type of submission (510(k)) generally relies on demonstrating substantial equivalence rather than presenting extensive de novo clinical study data with detailed acceptance criteria and performance metrics like those typically required for novel AI/ML devices or higher-risk devices.

Therefore, I cannot provide a table of acceptance criteria and reported device performance or other detailed study information because it is not present in the provided document. The document focuses on regulatory approval based on substantial equivalence, not on the detailed results of a performance study demonstrating specific acceptance criteria.

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"Dimer Dual Cure Temporary Resin Cement" is indicated for the temporary cementation of provisional restorations such as crowns and Bridges, inlays and onlays, Maryland bridges, veneers or for the temporary cementation of permanent dental restorations.

"Dimer Dual Cure Permanent Resin Cement" is indicated for the final cementation of implant prostheses, crowns and bridges, inlays and onlays, Maryland bridges, veneers, pins and posts and also periodontal splinting.

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I am sorry, but the provided text is a 510(k) premarket notification letter from the FDA regarding a dental cement. It does not contain any information about acceptance criteria or a study proving that a device meets such criteria.

The document primarily focuses on:

• Acknowledging the 510(k) submission for "Dimer Dual Cure Permanent Resin Cement" and "Dimer Dual Cure Temporary Resin Cement."
• Stating that the device is substantially equivalent to legally marketed predicate devices.
• Outlining the general controls and regulations applicable to the device.
• Providing the Indications for Use for both permanent and temporary resin cements.

Therefore, I cannot fulfill your request to describe acceptance criteria and a study from this document, as that information is not present.

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Orthodontic Flowable Bracket Adhesive is a light cured composite designed for use in the indirect bonding technique and with lingual retainers, archwire stops, and Invisalign® attachments. It can also be used for occlusal build-ups. Its low viscosity and precise syringe delivery make it easy to place and finish, and adaptable to a variety of clinical situations.

Orthodontic Flowable Bracket Adhesive is a light cured composite designed for use in the indirect bonding technique and with lingual retainers, archwire stops, and Invisalign® attachments. It can also be used for occlusal build-ups. Its low viscosity and precise syringe delivery make it easy to place and finish, and adaptable to a variety of clinical situations.

This document is a 510(k) clearance letter from the FDA for an Orthodontic Flowable Bracket Adhesive. It does not contain information about acceptance criteria or a study proving device performance as requested. The letter primarily states that the FDA has determined the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed.

Therefore, I cannot provide the requested information based on the provided text.

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"Self Cure Temporary Crown and Bridge Material" is indicated for the fabrication of temporary crown, partial crown, inlay, onlay and/or bridges.

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The provided document is a 510(k) clearance letter from the FDA for a medical device called "Self Cure Temporary Crown and Bridge Material." This type of document does not typically contain the detailed information required to describe acceptance criteria and the specifics of a study proving a device meets those criteria, especially for software-based or AI/ML devices.

The 510(k) letter primarily states that the device is substantially equivalent to a predicate device and is intended for the fabrication of temporary crowns, partial crowns, inlays, onlays, and/or bridges.

Therefore,Based on the provided document, I cannot extract the information required to populate the table and answer the questions regarding acceptance criteria and the study details. This document is a regulatory approval letter, not a study report.

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"BPA-Free Pit and Fissure Sealant" is indicated for the covering and sealing of pits and fissures in the occlusal surfaces of posterior teeth to aid in the resistance to caries in those surfaces.

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I'm sorry, but without further context, I cannot fulfill your request. The provided text is a letter from the FDA regarding a premarket notification for a medical device (BPA-Free Pit and Fissure Sealant); it does not contain information about acceptance criteria or a study that proves the device meets those criteria.

To help you, I would need a document that describes:

• The specific acceptance criteria for the device (e.g., performance metrics, thresholds).
• Details of a study conducted to evaluate the device against these criteria.
• Information about the study's methodology, sample size, ground truth establishment, and expert involvement.

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Granitec® Dual-Cure Core Build-Up is indicated for direct build-up of the crowns of teeth that have been badly broken down and are in need of a prosthetic crown in order to regain function. It is especially indicated for use under esthetic full porcelain and composite crowns, onlays and inlays where the underlying tooth structure and core restoration will show through the esthetic veneer. It can be used on vital or de-vital, endodontically treated teeth. It may be used with pins and posts and should be bonded to the tooth with a bonding agent.

N'Durance Dimer Core is indicated for direct build-up of the crowns of teeth that have been badly broken down and are in need of a prosthetic crown in order to regain function. It is especially indicated for use under esthetic full porcelain and composite crowns, onlays and inlays where the underlying tooth structure an d core restoration will show through the esthetic veneer. It can be used on vital or de-vital, endodontically treated teeth. It may be used with pins and posts and should be bonded to the tooth with a bonding agent.

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This document is largely a 510(k) clearance letter from the FDA for two dental devices, Granitec® Dual-Cure Core Build-Up and N'Durance Dimer Core. It states that the devices are substantially equivalent to legally marketed predicate devices.

The letter itself does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria. It is a regulatory approval document based on a finding of substantial equivalence, not a detailed report of performance testing.

Therefore, I cannot provide the requested information from the provided text. The document outlines the FDA's decision based on a review of the manufacturer's submission, but the details of the performance study and acceptance criteria are not included in this letter.

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"Light-Activated Low-Stress Thiol-Ene Composite Restorative Material" is a light Cure restorative material indicated for direct esthetic restoration of anterior and posterior teeth. It provides easy esthetics since it is formulated in shades matching the VITA Lumin® Shade guide. This low stress nanohybrid composite can be used in all classes of direct dental restorations, Class I, II, III, IV, and V. It may also be used for dental core build-ups

Light-Activated Low-Stress Thiol-Ene Composite Restorative Material

The provided text is a cover letter from the FDA regarding a 510(k) premarket notification for a medical device. It does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance or any other details about a study, as this information is not present in the provided document.

The document primarily focuses on:

• Confirming the substantial equivalence of the device to legally marketed predicate devices.
• Outlining the regulatory requirements that the manufacturer must comply with.
• Stating the intended use of the device ("Light-Activated Low-Stress Thiol-Ene Composite Restorative Material" indicated for direct esthetic restoration of anterior and posterior teeth, and for dental core build-ups).

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"Dimer Acid Derived Nanohybrid Composite" is a light cure restorative material indicated for direct esthetic restoration of anterior and posterior teeth. It provides simple esthetics since it is formulated in shades matching the VITA Lumin Shade guide. This low shrinkage nanohybrid composite can be used in all classes of direct dental restorations, Class I, II, III, IV, and V.

Dimer acid derived nanohybrid composite is for use in all dental cavity classes. The composite is a single light cured paste with a different monomer system chemistry than other filling composites that are currently available. The new resin system produces exceptionally high conversion values with a very low shrinkage.

This submission appears to be a 510(k) premarket notification for a dental composite material, not an AI/ML medical device. Therefore, the information requested about acceptance criteria and studies related to AI/ML device performance (such as sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance) is not applicable to this document.

The document describes a "Dimer Acid Derived Nanohybrid Composite" and primarily focuses on its intended use for dental cavity classes and claiming substantial equivalence to predicate devices, which is a common pathway for conventional medical devices.

Here's a breakdown of why an AI/ML-focused answer isn't possible from the provided text:

• No mention of AI/ML: The document does not contain any keywords or descriptions indicating the device incorporates artificial intelligence, machine learning, image analysis algorithms, or any form of computational intelligence.
• Device Type: It's a "Tooth shade resin material" or "light cure restorative material," which is a physical dental material, not a software or diagnostic imaging device.
• Substantial Equivalence: The basis for clearance is "substantial equivalence" to existing predicate devices based on functional similarity and indications for use. This process for conventional devices typically involves comparing material properties, performance characteristics (e.g., shrinkage, conversion values), and safety data, rather than AI performance metrics.

Therefore, I cannot provide a table of acceptance criteria and device performance, or details about sample sizes, experts, adjudication, or MRMC studies, as these concepts are not relevant to the information presented in this 510(k) summary.

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