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BRUSHABLE COMPOSITE is used to facilitate the brush/instrument application of dental composite restorative materials; to assist in direct veneering of anterior teeth, splinting, appiration of composite restorations. BRUSHABLE COMPOSITE may be used during layering especially if the air-inhibited surface has been affected.

The applicant device is a Brushable Dental Composite, classified as a Tooth Shade Resin Material. It is a low viscosity microfilled composite with a filler percentage of 36%. It is supplied as preloaded, plastic syringes. The material is extruded onto a suitable pad or well and applied to the instrument.

This document is a 510(k) summary for a dental composite, not a study report for a medical device with acceptance criteria and performance data in the typical sense of AI/ML or diagnostic devices.

Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" are not applicable or cannot be extracted from the provided text.

Here is an analysis based on the provided text, addressing the applicable points:

This document describes a 510(k) submission for a dental material (Brushable Composite) seeking substantial equivalence to a predicate device. It is not a clinical study report for a diagnostic or AI-powered medical device where performance metrics like sensitivity, specificity, or inter-reader agreement are typically established against predefined acceptance criteria.

Applicable Information from the Provided Text:

1. A table of acceptance criteria and the reported device performance:
   • Acceptance Criteria (Implicit for 510(k) Substantial Equivalence): The primary "acceptance criterion" for a 510(k) dental material is demonstrating substantial equivalence to a legally marketed predicate device. This is primarily assessed through comparison of intended use, composition, physical/mechanical aspects, and how the product is supplied and used. The FDA's letter explicitly states: "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..."
   • Reported Device Performance (Comparative Information): The provided table compares the applicant device (Cosmedent BRUSHABLE COMPOSITE) to the predicate device (Bisco SCULPTING RESIN). This table serves as the basis for demonstrating substantial equivalence rather than reporting explicit performance metrics against numerical 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):

   • Not Applicable. This document describes a comparison to a predicate device based on material characteristics, not a clinical study with a "test set" of patient data.

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):

   • Not Applicable. There is no "ground truth" derived from expert review of a test set in this 510(k) submission. The ground for equivalence relies on material science comparisons.

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

   • Not Applicable. No test set or expert adjudication process 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:

   • Not Applicable. This is a dental material, not an AI-assisted diagnostic device.

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

   • Not Applicable. This is a dental material, not an algorithm.

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

   • Not Applicable in the traditional sense. For this 510(k), the "truth" is established by comparing the physical, chemical, and functional properties of the new device to those of the predicate device, typically using standardized material testing methods relevant to dental composites (which are not detailed in this summary). The FDA's determination of "substantial equivalence" is the regulatory ground truth.

8. The sample size for the training set:

   • Not Applicable. No "training set" is involved as this is not an AI/ML device.

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

   • Not Applicable. No "training set" or corresponding ground truth establishment is applicable here.

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NANO COMPOSITE is designed for Class I-V dental restorations, direct veneering of anterior teeth, splinting, and repair of composite or ceramic restorations.

Cosmedent NANO COMPOSITE is a light-cure composite resin fabricated from difunctional acrylic monomers and silicaceous fillers. These materials possess physical and mechanical properties that allow them to function in the oral cavity with esthetic qualities that mimic natural tooth appearance.

The provided text is a 510(k) summary for a dental composite material, not an AI/ML device. Therefore, the questions related to AI/ML device performance, such as sample sizes for test/training sets, ground truth establishment, expert adjudication, or MRMC studies, are not applicable.

Here's the relevant information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by demonstrating substantial equivalence to the predicate device, Tetric EvoCeram. This involves comparing key physical and mechanical properties.

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

Not applicable. This is a material comparison study, not an AI/ML diagnostic study with a "test set" in that context. The data would have been generated from laboratory testing of the material. The document does not specify the sample sizes (e.g., number of specimens tested for each property) or data provenance in terms of country of origin, or if it was retrospective or prospective.

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

Not applicable. Ground truth in the context of AI/ML diagnostics for medical images is not relevant here. The "ground truth" for material properties is established through standardized laboratory testing methods.

4. Adjudication method for the test set

Not applicable. No expert adjudication is described for material property testing.

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 is not an AI/ML diagnostic device.

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

Not applicable. This is not an AI/ML diagnostic device.

7. The type of ground truth used

The "ground truth" for the device's performance is based on the results of physical and mechanical properties testing performed according to implied standard laboratory methods.

8. The sample size for the training set

Not applicable. This is not an AI/ML device, so there is no training set.

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

Not applicable. This is not an AI/ML device.

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Temporary CROWN AND BRIDGE Resin is indicated for use as a temporary restorative material for crown and bridge, inlay, and/or onlay restorations.

Cosmedent TEMPORARY CROWN AND BRIDGE RESIN is a self-cure composite resin fabricated from difunctional acrylic monomers and silicaceous fillers. These materials have sufficient physical properties to function in the oral cavity for up to 90 days and have esthetic qualities that mimic natural tooth appearance.

The provided text describes a 510(k) submission for a medical device, a Temporary Crown and Bridge Resin. This type of submission is for demonstrating substantial equivalence to a predicate device, not typically for proving new performance against acceptance criteria through a clinical study of the type usually associated with AI/software devices. Therefore, many of the requested points related to AI/software performance studies are not applicable to this document.

However, based on the information provided, here's what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance:

The "acceptance criteria" in this context are the physical and mechanical properties of the predicate device (Luxatemp) that the applicant device (Cosmedent TEMPORARY C&B Filling Material) aims to be substantially equivalent to. The reported performance is the measured properties of the Cosmedent device.

2. Sample size used for the test set and the data provenance: Not applicable. This document pertains to material properties testing, not a clinical study with a "test set" in the context of AI/software or diagnostic performance. The testing would have been conducted in a laboratory setting. No information on the number of samples tested for the material properties is provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for material properties like compressive strength is established through standardized laboratory testing methods, not expert consensus.

4. Adjudication method for the test set: Not applicable. Material properties are measured objectively.

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 is not an AI/software device.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an AI/software device.

7. The type of ground truth used: For the material properties (compressive strength, flexural strength, percent filler by weight, radiopacity), the ground truth is established through objective laboratory measurements following established standards for dental materials.

8. The sample size for the training set: Not applicable. This is not an AI/software device with a training set.

9. How the ground truth for the training set was established: Not applicable. This is not an AI/software device.

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The product is used either by a dental professional in the dental office or by a patient at home to treat dentin sensitivity.

Cosmedent TOOTH DESENSITIZER is a 3% potassium nitrate and 1200 ppm fluoride ion gel desensitizer. The indication for this product is tooth discomfort caused by dentine sensitivity. TOOTH DESENSITIZER is a gel desensitizer device based on the well documented effects of potassium nitrate and fluoride ion on dentine sensitivity due to patent dentinal tubules. TOOTH DESENSITIZER is available as a clear, green-colored, gel. It can be used either by gently brushing the affected area with the product or it can be used in a custom tray.

The provided text is a 510(k) premarket notification for a tooth desensitizer. It details the device's description, intended use, and comparison to a legally marketed predicate device.

However, the document does not contain any information regarding clinical studies, performance data, acceptance criteria, sample sizes (for test or training sets), expert qualifications, adjudication methods, or MRMC comparative effectiveness studies.

The 510(k) summary (from document {0}) states: "TOOTH DESENSITIZER is a gel desensitizer device based on the well documented effects of potassium nitrate and fluoride ion on dentine sensitivity due to patent dentinal tubules." This implies that the device's effectiveness relies on the known mechanisms of its active ingredients, rather than new clinical trials specifically for this product to prove novel efficacy beyond what is already established for these ingredients.

Therefore, I cannot populate the table or answer most of the questions you've posed, as the necessary information is not present in the provided text.

Here is what can be inferred or stated from the provided text:

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

• Acceptance Criteria: Not specified in the document.
• Reported Device Performance: Not specified as quantitative performance metrics. The document states it is "based on the well documented effects of potassium nitrate and fluoride ion on dentine sensitivity," suggesting reliance on established scientific literature for its active ingredients rather than new performance data.

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

• Not specified. No test set data appears to have been presented.

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)

• Not specified. No ground truth establishment for a test set is mentioned.

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

• Not specified. No test set adjudication is mentioned.

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 is a medical device (tooth desensitizer), not an AI/imaging device.

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

• Not applicable. This is a medical device (tooth desensitizer), not an AI/imaging device.

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

• Not specified directly. The submission relies on "well documented effects of potassium nitrate and fluoride ion on dentine sensitivity," implying that the ground truth for their efficacy is based on existing scientific and clinical understanding of these active ingredients.

8. The sample size for the training set

• Not applicable. No training set is mentioned as this is not an AI/machine learning device.

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

• Not applicable. No training set is mentioned.

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Resin Tooth Bonding Agent is used to facilitate the adhesive bonding of restorative/preventive dental materials to dental hard tissues as well as to other restorative materials.

Cosmedent Resin Tooth Bonding Agent is a dual-cure 4th generation resin tooth bonding agent based on an acetone solution of room temperature polymerizing dimethacrylates. The device consists of two bottles designated as Primer A and Primer B. Primer A can be used alone and light cured, or it can be mixed with Primer B whereupon the adhesive will self cure in a clinically appropriate amount of time. In either case, two coats of the adhesive are applied to the prepared teeth. The adhesive bond strength of the device is approximately 25 MPa. The product is intended to be used to promote the adhesion of resin composite restoratives to dentin and enamel.

This device, Cosmedent Resin Tooth Bonding Agent, is a dual-cure 4th generation resin tooth bonding agent. The provided text indicates it's a 510(k) submission, meaning the manufacturer is demonstrating that their new device is substantially equivalent to a legally marketed predicate device. This type of submission relies on comparison to a predicate device rather than extensive new clinical trials to establish safety and effectiveness. Therefore, the information typically found in a clinical study report proving acceptance criteria is not present in this document.

However, based on the provided text, we can infer some "acceptance criteria" through the comparison made to the predicate device, Bisco All-Bond 2 (K910860). The primary performance metric mentioned for both the applicant and predicate device is adhesive bond strength.

Here's the breakdown of the information requested, based on the available text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The "acceptance criteria" here are inferred from the performance of the legally marketed predicate device. For a 510(k), substantial equivalence implies that the new device's performance should be comparable to or not worse than the predicate's performance in clinically relevant aspects.

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

The document does not detail specific sample sizes for testing or data provenance for the reported bond strength values. 510(k) submissions often rely on bench testing and comparisons to predicate devices, rather than large-scale clinical trials. The reported bond strength values (25 MPa and 28 MPa) would typically come from in-vitro (bench) testing.

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

Not applicable. The document does not describe the establishment of a "ground truth" using experts for the reported bond strength. These values are typically derived from standardized material testing in a laboratory setting.

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

Not applicable. The document does not describe an adjudication method as no expert-based review or clinical trial is detailed for the bond strength measurements.

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 bonding agent, a physical material, and does not involve AI or human "readers." Therefore, an MRMC study is not relevant.

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

Not applicable. This device is a dental bonding agent, not a software algorithm.

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

The "ground truth" for the reported bond strength is derived from physical/material testing (e.g., tensile or shear bond strength tests) typically conducted in a laboratory setting according to recognized standards (e.g., ISO standards for dental materials).

8. The sample size for the training set

Not applicable. As a material device, there is no "training set" in the context of machine learning or AI.

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

Not applicable. There is no "training set" for this device.

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Dental pit and fissure sealant .

Cosmedent PIT & FISSURE SEALANT is a light-cure, moderately filled, resin based dental sealant. The product will cure or harden upon application of visible light at a wavelength of approximately 465 nanometers at an energy of at least 350 milliwatts. PIT & FISSURE SEALANT is a relatively low viscosity polymerizable resin based on bis-GMA, urethane, or similar room temperature curing diacrylate monomers. The product is intended to be applied to the developmental grooves and fissures of teeth to prevent these areas from being damaged by carious organisms. PIT & FISSURE SEALANT is available either as a clear unfilled resin or as a filled resin. The filled resin is white and mimics occlusal tooth color.

This document is a 510(k) summary for a dental pit and fissure sealant. It does not contain information about acceptance criteria or a study proving device performance as typically expected for medical AI/ML devices. Instead, it focuses on the device's description, intended use, and substantial equivalence to a predicate device.

Therefore, I cannot provide the requested information. The document focuses on regulatory approval based on demonstrating substantial equivalence, not on specific performance criteria derived from a clinical or technical study as would be relevant for an AI/ML device.

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• A-SILICONE is a dental impression material intended to be placed on an impression . tray and used to reproduce the structures of a patient's teeth and gums.
• A-SILICONE is also intended to be used as a bite registration or occlusal registration . material.

A-SILICONE is vinyl polymethyl siloxane dental impression material composed of four viscosities or bodies including: putty, heavy body, medium body, and light body. The material is suitable for use in traditional double mix technique, monophase technique, and putty-wash technique as well as unique combinations of techniques.

Here's an analysis of the provided information regarding the A-SILICONE device, focusing on acceptance criteria and the study proving it:

The provided document is a 510(k) summary for a dental impression material named A-SILICONE. A 510(k) submission primarily demonstrates substantial equivalence to a previously legally marketed device (predicate device), rather than directly proving acceptance against a set of performance criteria through a traditional clinical study with defined ground truth and expert adjudication in the same way a diagnostic AI might be evaluated.

Therefore, the answers below will reflect this context, explaining that the "acceptance criteria" here are essentially the properties and performance parameters that need to be comparable to predicate devices for a favorable substantial equivalence determination. The "study" for this type of device is the testing conducted to measure these properties against established standards or predicate device performance.

Acceptance Criteria and Study for A-SILICONE

1. Table of Acceptance Criteria and Reported Device Performance

For a 510(k) submission of a dental impression material, the "acceptance criteria" are the physical and chemical properties that demonstrate it is as safe and effective as predicate devices. The reported device performance is measured against these properties.

2. Sample Size Used for the Test Set and the Data Provenance

The document does not specify a "test set" in the context of patient data or a clinical trial. For material properties, testing is typically done on a sufficient number of material samples (batches or specimens) to ensure statistical validity and reproducibility of the measurements. This is in vitro testing, not in vivo (patient) testing.

• Sample Size: Not explicitly stated, but for physical/chemical property testing of materials, this would typically be multiple samples per batch, and multiple batches to demonstrate consistency.
• Data Provenance: The data would be derived from laboratory testing of the A-SILICONE material itself, likely performed by the manufacturer (Cosmedent, Inc.) or a contract testing lab. It is in vitro (laboratory) data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This type of information (experts establishing ground truth for a test set) is not applicable to a 510(k) submission for a dental impression material demonstrating substantial equivalence through physical property testing. "Ground truth" in this context refers to the measured physical and chemical properties of the material itself, determined by standardized laboratory methods (e.g., ISO 4823 for consistency). These are objective measurements, not subjective evaluations requiring expert consensus.

4. Adjudication Method for the Test Set

Not applicable. There is no "adjudication method" in the sense of reconciling differences in expert opinion for material property testing. Measurements are objective and follow standard protocols.

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 is not an AI/diagnostic device. It is a dental impression material. MRMC studies are used for evaluating diagnostic performance, often with AI assistance, which is irrelevant for this product.

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

Not applicable. This is not an algorithm or AI device.

7. The Type of Ground Truth Used

The "ground truth" for this device's evaluation is based on standardized physical and chemical property measurements (e.g., consistency by ISO 4823, strain in compression, recovery from deformation, linear dimensional change, hardness) as well as a demonstration that its intended use and composition are comparable to legally marketed predicate devices. This is a form of empirical measurement against established material science standards.

8. The Sample Size for the Training Set

Not applicable. This is a physical material, not a machine learning model, so there is no "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable. As there is no "training set" for a physical material, there is no ground truth to establish for one. The "ground truth" for material properties is established through standardized laboratory testing and measurement protocols.

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Dental core buildup material for use with 4th or 5th generation resin adhesive primer/bonding systems.

CORE PASTE is a dual-cure, radiopaque, filled, resin based core buildup material. The product will self-cure upon mixing equal parts of base and catalyst pastes. The setting time and resultant properties can be improved by further curing with a visible light dental curing unit. CORE PASTE is a high strength product ideally suited to buildup or replace lost tooth structure and to perform as a foundation restoration or core. It is used to build a damaged tooth to ideal anatomic form before it is prepared for a fixed dental prosthesis such as a crown. CORE PASTE is available in three shades: a blue material which serves to sharply contrast with tooth structure, a white opaque shade with similar clinical effects, and an esthetic A2 shade for optimal optical effects under esthetic translucent crown materials.

I am sorry, but 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 core buildup material named "CORE PASTE", detailing its intended use, description, and substantial equivalence to predicate devices, and the FDA's clearance letter. It does not include details on formal acceptance criteria or performance studies with the specific metrics you requested.

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Use for: Primosplint System should be used for producing functional therapy and bite splints.

Primosplint is a light composite developed for functional therapy bite splints and other applications. It is fabricated outside of the mouth from stone models. It may be polished mechanically or by the use of a glaze.

This document is a 510(k) clearance letter from the FDA for the Primosplint System. It does not contain information about acceptance criteria or a study proving device performance as typically expected for medical device evaluations. The letter primarily establishes substantial equivalence to a legally marketed predicate device.

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 provided text, and what is missing:

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

• Information not provided. The document does not describe specific performance characteristics, acceptance criteria, or a study that measures and reports these.

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

• Information not provided. There is no mention of a test set, sample size, or data provenance.

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)

• Information not provided. There is no mention of a test set or experts for ground truth.

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

• Information not provided. No test set 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

• Information not provided. This device is a "light composite developed for functional therapy bite splints," indicating it's a dental material, not an AI-assisted diagnostic tool. Therefore, an MRMC study related to AI assistance is not applicable.

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

• Information not provided and not applicable. This is not an algorithmic device.

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

• Information not provided. No ground truth is discussed as no study is detailed.

8. The sample size for the training set

• Information not provided. No training set is discussed.

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

• Information not provided. No training set or ground truth is discussed.

Summary from the provided document:

The document is a 510(k) clearance letter confirming that the Primosplint System is substantially equivalent to a legally marketed predicate device. The basis for clearance is not through a detailed performance study with acceptance criteria, but rather through demonstrating equivalence to existing devices. The key information provided about the device is:

• Trade/Device Name: Primosplint System
• Regulation Number: Unclassified
• Regulation Name: None
• Regulatory Class: None
• Product Code: MQC
• Indications for Use: Producing functional therapy and bite splints.
• Description of Device: A light composite developed for functional therapy bite splints and other applications. Fabricated outside of the mouth from stone models. May be polished mechanically or by the use of a glaze.
• Review Type: Section 510(k) premarket notification.
• Basis for Clearance: Substantial equivalence to legally marketed predicate devices.
• Confidential Chemical Analysis: Mentioned in "Rein Maly SachSR Appendix B," but the details are not included in this letter.

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