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Bond-3 Adhesive is used for the adhesion of tooth (dentin and enamel) to various polymeric filling materials (composites) and used with other conditioners or combination of conditioners for bonding composite to metal including amalgam, gold, semi precious, and non precious alloys, porcelain and glass and luting of same to Dentin and Enamel.

Bond-3 Adhesive and Dentin Conditioning Adhesive System (Bond-1) K936222 contain the same materials. However, Bond-3 Adhesive Contains additional Methacryl-POSS for added improvements. Safety and effectiveness have not been affected.

This document is a 510(k) submission for a dental adhesive (Bond-3 Adhesive). It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria and results.

Therefore, many of the requested details about acceptance criteria, study design, and performance metrics are not available in the provided text. The submission explicitly states that "Safety and effectiveness have not been affected" by the addition of Methacryl-POSS, implying that the performance is considered similar to the predicate device (Bond-1 Adhesive K936222) which shares the same materials.

Here's a breakdown of what can and cannot be extracted from the given text:

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

• Not available. The document states that Bond-3 Adhesive contains additional Methacryl-POSS for "added improvements" and then asserts "Safety and effectiveness have not been affected." This is a claim of equivalence, not a presentation of specific acceptance criteria or performance data for Bond-3 itself. For a dental adhesive, acceptance criteria would typically involve bond strength (e.g., shear or tensile bond strength) to dentin, enamel, and various restorative materials, as well as biocompatibility, shelf life, and handling properties. None of these are detailed here.

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

• Not available. No specific test set or study data is presented to evaluate the performance of Bond-3 Adhesive against acceptance criteria. The submission relies on the substantial equivalence to a predicate device (Bond-1 Adhesive K936222) which is stated to contain the same materials.

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

• Not applicable/Not available. Since no specific performance study is detailed, there's no mention of a test set requiring expert ground truth establishment.

4. Adjudication method for the test set:

• Not applicable/Not available. As above, no performance study or 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:

• Not applicable. This device is a dental adhesive, not an AI-powered diagnostic or assistive tool. MRMC studies are irrelevant in this context.

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 (expert consensus, pathology, outcomes data, etc):

• Not applicable/Not available. No specific performance study is detailed where ground truth would be established. The regulatory decision is based on substantial equivalence.

8. The sample size for the training set:

• Not applicable/Not available. This is a physical dental adhesive, not a machine learning model, so there is no "training set."

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

• Not applicable/Not available. As above, no training set exists for this device.

Summary based on the provided text:

The provided document is a 510(k) summary for a dental adhesive. It aims to demonstrate substantial equivalence to a previously cleared predicate device (Bond-1 Adhesive K936222). The key assertion is that the addition of Methacryl-POSS to Bond-3 Adhesive does not adversely affect safety and effectiveness, implying its performance is comparable to the predicate. There are no detailed performance studies, acceptance criteria, or specific test results presented in this submission. The FDA's letter confirms that the device is "substantially equivalent" to legally marketed predicate devices, allowing it to proceed to market under general controls.

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Bond-1 C&B is used for adhesion to dentin and bonding various polymeric filling materials (composites). Also, Bond 1C&B is used for bonding of composite to metal, including (composited) i semi precious and non precious alloys, porcelain and glass and luting of same to Dentin and Enamel. Bond 1 C&B was approved by the FDA on March 21, 2000 under 510(k) # K994359.

We are adding a component called Bond-1 Self Cure Activator to be used in conjunction with Bond 1 C&B. The formula for Bond-1 Self Cure Activator is attached in the application. Bond-1 Self Cure Activator, when mixed with Bond-1 C&B will allow Bond-1 C&B to cure with or without the use of light.

Bond-1 C&B is used for adhesion to dentin and bonding various polymeric filling materials (composites). Also, Bond 1C&B is used for bonding of composite to metal, including (composited) i semi precious and non precious alloys, porcelain and glass and luting of same to Dentin and Enamel. Bond 1 C&B was approved by the FDA on March 21, 2000 under 510(k) # K994359.

We are adding a component called Bond-1 Self Cure Activator to be used in conjunction with Bond 1 C&B. The formula for Bond-1 Self Cure Activator is attached in the application. Bond-1 Self Cure Activator, when mixed with Bond-1 C&B will allow Bond-1 C&B to cure with or without the use of light.

This document describes a 510(k) submission for a dental bonding agent, Bond-1 C&B, with the addition of a "Bond-1 Self Cure Activator." It is a regulatory submission for a Class II medical device (Resin Tooth Bonding Agent) seeking clearance based on substantial equivalence to a previously approved device.

Crucially, this is not a study that proves a device meets acceptance criteria in the way a diagnostic AI device or a complex medical device with performance metrics would. This submission is for a dental adhesive and its self-cure activator. The "acceptance criteria" here are related to chemical composition, material properties, and functionality, primarily demonstrating that the new component (self-cure activator) does not negatively impact the established performance of the existing Bond-1 C&B and provides the intended self-curing capability.

Therefore, many of the requested categories (like sample size for test sets, expert ground truth, MRMC studies, standalone performance, training sets for AI) are not applicable to this type of device submission.

Here's how to address the request based on the provided document:

Acceptance Criteria and Device Performance Study for Bond-1 C&B with Self-Cure Activator

This 510(k) submission (K013543) details the addition of a "Bond-1 Self Cure Activator" to an existing FDA-approved dental bonding agent, Bond-1 C&B (K994359). The "study" referenced in the document is the justification for substantial equivalence, focusing on the functionality of the new activator. The acceptance criteria relate to the intended function of the self-cure activator, which is to allow Bond-1 C&B to cure with or without light.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified in the provided documents. For a chemical additive, testing would likely involve a series of material property tests (e.g., bond strength, curing time, cytotoxicity) on a certain number of samples, not a "test set" in the sense of patient data.
• Data Provenance: Not specified. For a dental material, this would typically be laboratory test data generated by the manufacturer.

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

• Not Applicable. For a dental bonding agent and its activator, "ground truth" is established through standardized material testing methods (e.g., ISO or ADA standards for bond strength, curing characteristics) conducted in a laboratory, rather than expert interpretation of images or clinical outcomes.

4. Adjudication Method for the Test Set

• Not Applicable. Adjudication methods like 2+1 or 3+1 are used for expert review of subjective data (e.g., medical images). Material property testing results are objective and do not require expert adjudication in this manner.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• Not Applicable. This is a dental bonding agent, not a diagnostic imaging device or an AI system that assists human readers. MRMC studies are for evaluating the impact of AI on human reader performance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Not Applicable. This device is a chemical product, not an algorithm or AI system.

7. Type of Ground Truth Used

• Material Property Testing Results: The "ground truth" for this device would be objective measurements from standardized laboratory tests, demonstrating the efficacy of the self-cure mechanism (e.g., successful polymerization in the absence of light) and maintaining the established properties of Bond-1 C&B. This would typically include chemical characterization, mechanical property testing (e.g., shear bond strength, flexural strength), and biocompatibility assays. The document states "The formula for Bond-1 Self Cure Activator is attached in the application," implying that the chemical composition itself is a key part of the ground truth and justification.

8. Sample Size for the Training Set

• Not Applicable. This is a chemical product, not an AI/machine learning model that requires a training set.

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

• Not Applicable. As there is no training set, this does not apply.

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Dentin Conditioning and Adhesive System (Bond-1) is used for adhesion to Dentin of various polymeric filling materials (composites) used with other conditioners or combination of conditioners for bonding of composite to metal including amalgam, gold, semi precious and non precious alloys, porcelain and glass and luting of same to dentin and enamel.

We are adding a component called Bond-1 Self Cure Activator to be used in conjunction with Dentin Conditioning and Adhesive System (Bond-1). The formula for Bond-1 Self Cure Activator is attached in the application.

Dentin Conditioning and Adhesive System (Bond-1) is used for adhesion to Dentin of various polymeric filling materials (composites) used with other conditioners or combination of conditioners for bonding of composite to metal including amalgam, gold, semi precious and non precious alloys, porcelain and glass and luting of same to dentin and enamel.

We are adding a component called Bond-1 Self Cure Activator to be used in conjunction with Dentin Conditioning and Adhesive System (Bond-1). The formula for Bond-1 Self Cure Activator is attached in the application. Bond-1 Self Cure Activator, when mixed with Dentin Conditioning and Adhesive System, allows the Bond-1 C&B to cure with or without the use of light.

The provided text is a 510(k) summary for a dental adhesive system (Dentin Conditioning and Adhesive System (Bond-1)) seeking to add a new component, Bond-1 Self Cure Activator. This document is a regulatory filing, not a scientific study report. Therefore, it does not contain the acceptance criteria or a study demonstrating the device meets those criteria.

The information typically found in such a study would include:

• Acceptance Criteria for Performance: These would define the minimum performance thresholds for the dental adhesive, such as bond strength (e.g., megapascals of shear or tensile bond strength) to dentin and other restorative materials, or microleakage scores. These criteria would likely be based on international standards (e.g., ISO standards for dental materials) or established clinical benchmarks.
• Reported Device Performance: This would be the actual measured performance of the device (Bond-1 with the Self Cure Activator) in laboratory tests, compared against the acceptance criteria.
• Study Design: Details about the type of study (e.g., in vitro bond strength test, microleakage study), sample sizes for the test groups (e.g., number of teeth, number of bonded specimens), and the materials used.
• Data Provenance: Information on where the tests were conducted.
• Ground Truth Establishment: For dental materials, "ground truth" often refers to the objective measurement of a physical property (like bond strength). This is not typically established by human experts in the same way as an imaging device. Instead, it's determined by standardized laboratory procedures and equipment (e.g., universal testing machine for bond strength).
• Training Set Data: This kind of dental material study typically doesn't involve "training sets" in the machine learning sense. The performance is measured directly.

Summary based on the provided text:

This document is a 510(k) Pre-market Notification for a modification to an existing dental adhesive system. It does not present a study or acceptance criteria for the device's performance. Instead, it states that a new component (Bond-1 Self Cure Activator) is being added to an already approved device (Dentin Conditioning and Adhesive System (Bond-1), previously approved under K973388). The goal of this filing is to demonstrate substantial equivalence to the predicate device, not necessarily to re-demonstrate comprehensive performance against specific acceptance criteria in a new study.

The text does not include the following information that would be necessary to answer the prompt directly:

1. A table of acceptance criteria and the reported device performance.
2. Sample sizes used for any test set or data provenance.
3. Number of experts used to establish ground truth or their qualifications.
4. Adjudication method for a test set.
5. Information on a Multi-Reader Multi-Case (MRMC) comparative effectiveness study.
6. Information on a standalone algorithm performance.
7. The type of ground truth used (beyond implying standardized material testing if a study were present).
8. Sample size for a training set.
9. How ground truth for a training set was established.

In essence, the provided document is a regulatory letter acknowledging receipt and review of a 510(k) submission, and the 510(k) summary itself is a description of the device and its intended use, rather than a detailed report of a study and its results against acceptance criteria.

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A vante Micro Crystal System is a porcelain-fused-to-metal (PFM) restorative system to be layered on conventional PFM alloys to make crowns and multiple-unit bridges. The porcelains can also be used with refractory or foil to create veneer restorations.

Avante Micro Crystal System is a porcelain-fused-to-metal (PFM) restorative system to be layered on conventional PFM alloys to make crowns and multiple-unit bridges. The porcelains can also be used with refractory or foil to create veneer restorations. The composition of Avante Porcelain is similar to that of Synspar Porcelain, K910303. The composition of Available of Avante was adjusted in Avante Porcelain to result in a lower firing temperature compared to Synspar. However, the actual list of chemical compounds present in Avante is similar to that of Synspar.

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study proving the device meets acceptance criteria. The document describes a 510(k) submission for a dental restorative system (Avante Micro Crystal System) and its substantial equivalence to a predicate device (Synspar Porcelain). It mentions that cytotoxicity testing was not performed due to the similarity in composition to other products on the market and that the lower firing temperature of Avante has no effect on the safety and effectiveness of the material if properly fired.

The document is a 510(k) summary and an FDA clearance letter, which focuses on regulatory approval based on substantial equivalence rather than detailed performance study results with specific acceptance criteria.

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FIRST FILL R.C.S. is to be used for permanent obturation of root canals of teeth in combination with root canal points.

FIRST FILL R.C.S. is to be used for permanent obturation of root canals of teeth in combination with root canal points. The resins used in First Fill RCS are the common dental methacrylate resins.

The provided text does not contain information about the acceptance criteria or a study proving that a device meets those criteria. The document is a 510(k) summary for a dental root canal sealant (FIRST FILL R.C.S.) seeking substantial equivalence to a predicate device.

Specifically, the document states:

• No acceptance criteria: The document does not define any specific performance metrics or thresholds that the device needed to meet.
• No performance study: There is no description of a study conducted to assess the performance of FIRST FILL R.C.S. against any criteria. The basis for clearance is substantial equivalence.
• Substantial Equivalence: The primary information provided is that Jeneric/Pentron, Inc. believes FIRST FILL R.C.S. is "substantially equivalent to Ultradent's EndoRez Root Canal Sealant, K992097" and that the FDA concurred with this determination based on the premarket notification. The materials are noted as "common dental methacrylate resins" and "Cytotoxicity results have been submitted in Section 15.0" (though Section 15.0 is not provided).

Therefore, I cannot populate the requested table or answer the specific questions about sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment, as this information is not present in the provided text.

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