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Correct Plus 1 is a vinyl polysiloxane impression material which is to be used for taking impression of inlays, crowns & bridges, orthodontic appliances, precision attachments and veneers.

Correct Plus 1 impression material (Fast Set) are versatile impression materials designed to accommodate impressions of inlays, crowns and bridges, orthodontic appliances, precision attachments and veneers. The hydrophilic nature of these materials provides outstanding detail in the presence of fluids and exceptional tear strength ensures your detailed impression will remain intact upon removal. Correct Plus 1 impression material provides multiple packaging options and various set times to accommodate all of your impression needs. For optimal patient acceptance, Correct Plus 1 impression material is available in unflavored and Berry.

Here's a breakdown of the acceptance criteria and the study information for the "Correct Plus 1" device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly list "acceptance criteria" for each performance characteristic with numerical targets. Instead, the study aims to demonstrate substantial equivalence to a predicate device ("Correct Plus" K001218) by comparing performance characteristics. Therefore, the "acceptance criteria" can be inferred as "performance comparable to the predicate device."

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

The document only states that "bench testing" was conducted to evaluate performance characteristics without specifying the sample size for each test. The data provenance is not explicitly stated as foreign or domestic, but it is retrospective in the sense that the new device's performance is being compared to an already marketed predicate device, and the testing was conducted to support the 510(k) submission.

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

Not applicable. This study focuses on physical and chemical properties of a dental impression material, not diagnostic accuracy or expert interpretation of medical images. The "ground truth" for these tests would be established by validated measurement techniques and adherence to ISO standards, not expert consensus in a clinical context.

4. Adjudication Method for the Test Set

Not applicable. As described above, this study is not evaluating expert-dependent outcomes.

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 an impression material, not an AI-powered diagnostic tool. No MRMC studies were conducted.

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

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

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The ground truth for most of the performance characteristics (e.g., Work Time, Hardness, Tear Strength, Dimensional Change, etc.) would be objective measurements obtained through standardized laboratory testing following established protocols (often ISO standards or similar industry-accepted methods). For biocompatibility, the ground truth is established by passing the specified ISO tests (L929 MEM Elution Test, Kligman Maximization Test, Oral Irritation Test), indicating the absence of adverse biological effects according to the test criteria.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device, so there is no concept of a "training set."

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

Not applicable. There is no training set for this type of device.

Summary of the Study Proving Device Meets Acceptance Criteria:

The study proving the device meets acceptance criteria is a non-clinical performance study focusing on physical, chemical, and biological properties.

• Study Type: Bench testing and biocompatibility testing.
• Objective: To demonstrate substantial equivalence of Correct Plus 1 to the predicate device, Correct Plus (K001218).
• Methods:
  • Biocompatibility: Correct Plus 1 was subjected to ISO L929 MEM Elution Test (cytotoxicity), ISO Kligman Maximization Test (sensitization), and ISO Oral Irritation Test. The device "passed" these tests, demonstrating it is safe for its intended use.
  • Bench Testing (Physical/Chemical Properties): Correct Plus 1 was tested for various performance characteristics including Work Time, Oral Set Time, Catalyst Viscosity, Base Viscosity, Out Gassing, Hardness, Mixed Consistency, Dimensional Change, Detail Reproduction, Compatibility with Gypsum, Elastic Recovery, Strain in Compression, Tensile Strength, Tensile Elongation, Tear Strength, and Contact Angle. The results of these tests were compared "as compare to the predicate device, Correct Plus."
• Results & Conclusion: Based on the successful biocompatibility tests and the comparison of bench testing data showing similar performance characteristics to the predicate device, the manufacturer concluded that the "clinical performance of Correct Plus 1 is substantially equivalent to the predicate device."
• Clinical Testing: No clinical testing was conducted on this product.

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TempSpan Clear Matrix is indicated for:

• Use as a clear template for intra oral polymerization of light activated materials to create temporary restorations.
• Use as a general impression material for monophase impression techniques.

TempSpan Clear Matrix Material is a clear preoperative impression material that will reproduce the finest detail resulting in extremely accurate provisional restorations. Use as the preliminary impression material for intraoral and extra-oral polymerization of dual-cure provisional materials. Light curing dual-cure provisional materials may eliminate or drastically reduce the oxygen-inhibited smear layer. TempSpan Clear Matrix Material is a medium viscosity vinyl polysiloxane material. It is packaged in a 50ml auto-mix cartridge, with an oral set time of 2 minutes. TempSpan Clear Matrix Material enables provisional restorations fabricated with dual cure materials to be light cured intra-orally and extra-orally. This process shortens the provisional procedure, minimizing chair time and patient discomfort. Additional features include: clear formula for intra-oral light curing, auto-mix delivery, and a quick set time with a working time of 1 minute and an oral set time of 2 minutes.

Here's a breakdown of the acceptance criteria and the study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Note: The document states that the performance characteristics (Work Time, Oral Set Time, and Shore A Hardness) were "evaluated" and provided data for comparison to predicate devices, but the specific numerical results for TempSpan Clear Matrix or the predicate devices, and thus explicit acceptance criteria values, are not included in the provided text. The conclusion of substantial equivalence implies that these characteristics were within acceptable ranges compared to the predicates.

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

• Sample Size for Test Set: Not explicitly stated. The document refers to "bench testing" without providing specific sample sizes for each test.
• Data Provenance: The studies were non-clinical (bench testing and biocompatibility). The country of origin of the data is not specified but is assumed to be from the manufacturer or accredited testing facilities. The data is retrospective in the sense that it supports a premarket notification for a new device, comparing it to existing ones.

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

• Number of Experts: Not applicable. This was a non-clinical bench testing study. The "ground truth" was established by objective physical and chemical testing methods (e.g., ISO standards for biocompatibility and laboratory measurements for physical properties).
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set:

• Adjudication Method: Not applicable. This was a non-clinical bench testing study. The results of the tests (biocompatibility, work time, set time, hardness) would be objectively measured and compared, not adjudicated.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:

• MRMC Study: No. The document explicitly states: "Clinical testing has not been conducted on this product."

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study was Done:

• Standalone Study: Yes, in the sense that the device's physical and biocompatibility properties were tested independently. This device is a dental impression material, not an algorithm, so the concept of "standalone performance" applies to its inherent material properties rather than an AI algorithm.

7. The Type of Ground Truth Used:

• Type of Ground Truth:
  • For biocompatibility: Adherence to ISO standards (ISO Intramuscular Injection Test and ISO L929 MEM Elution Test) results (negligible irritant, non-cytotoxic).
  • For performance characteristics (Work Time, Oral Set Time, Shore A Hardness): Objective physical measurements compared against the properties of legally marketed predicate devices. The "ground truth" here is the established performance of the predicate devices.

8. The Sample Size for the Training Set:

• Sample Size for Training Set: Not applicable. This is a physical medical device, not an AI/machine learning algorithm. Therefore, there is no "training set."

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

• How Ground Truth for Training Set was Established: Not applicable, as there is no training set for this device.

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B1P Adhesive is an adhesive designed to be used for all direct and indirect applications including, but not limited to, the following:

Direct Applications

• Direct bonding to dentin and/ or enamel .
• Bonding composite to composite, porcelain and/ or metal .
• . Opaquing metal (used in conjunction with an opaque resin stain or cement)
• Bonding with dual cure and self cure composite resins, such as cements and core build up . materials
• Amalgam sealing
• Dentin sealing ●

Indirect applications

• Indirect bonding of all composite, all ceramic, PFM and alloy crowns, bridges, inlays, ● onlays and veneers (used in conjunction with resin luting agents)
• Bonding of fiber and metal posts (in conjunction with resin luting agents) ●

B1P Adhesive is a fifth generation dental bonding agent that is intended to be used for direct composite bonding and indirect restoration in combination with a dental restorative material. The formula is used based on a total etch technique and combines the primer and adhesive into one component. The application procedure requires steps of acid etching and rinsing, followed by the application of the B1P Adhesive. It is a light curable adhesive with the option of being dual cured when mixed with the dual cure activator.

Here's an analysis of the provided text, focusing on acceptance criteria and supporting studies for the B1P Adhesive device:

The documentation for K111431, B1P Adhesive, does not explicitly define quantitative acceptance criteria in a table format as often seen in medical device submissions for diagnostic or AI-driven devices. Instead, the "acceptance criteria" are implied through the concept of "substantial equivalence" to predicate devices, supported by specific bench test results (bonding strengths) and biocompatibility.

The study presented is not a typical clinical study with a defined test set, ground truth experts, or complex statistical analysis for performance metrics akin to an AI device. It's a submission for a dental bonding agent, and the evaluation is primarily focused on demonstrating physical and chemical properties similar to existing, legally marketed devices.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

As mentioned, explicit, quantitative acceptance criteria in a table format are not present in the provided text. The overall "acceptance criterion" is achieving substantial equivalence to the predicate devices. The performance data is presented qualitatively and comparatively.

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

• Sample Size for Test Set: Not specified. The document refers to "bench testing used to evaluate the performance characteristics of B1P Adhesive compared to the predicate devices" for bonding strengths. Details on the number of samples or specimens tested are not provided.
• Data Provenance: Not explicitly stated, but assumed to be from laboratory bench testing conducted by the manufacturer, Sybron Dental Specialties, Inc. (or affiliated labs). The data is retrospective in the sense that it's generated for this submission, not from a prospective clinical trial. Country of origin not mentioned but likely US-based given the submitter's location.

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

This information is not applicable/not provided in the context of this submission. The "ground truth" for bonding strengths would be derived directly from the physical measurements obtained during the bench tests, not from expert consensus or interpretation.

4. Adjudication Method for the Test Set

This is not applicable/not provided. There was no expert-based adjudication process for the bench tests described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

This is not applicable/not provided. The device is a dental bonding agent, not an AI-driven diagnostic or assistive technology. Therefore, no MRMC study or AI-related comparative effectiveness analysis was performed or is relevant.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This is not applicable/not provided. The device is a physical product (a dental bonding agent), not a standalone algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the performance evaluation (bonding strengths) was based on direct laboratory measurements from bench testing. For biocompatibility, it was based on adherence to ISO 10993 standards. There was no pathology, expert consensus, or outcomes data used as ground truth in the way it might be for a diagnostic device.

8. The Sample Size for the Training Set

This is not applicable/not provided. There is no "training set" in the context of this device and its evaluation. The product's formulation and development would involve research and development, but this is not framed as a "training set" for an algorithm.

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

This is not applicable/not provided as there is no training set mentioned or implied. Product development for a chemical formulation relies on chemical principles, materials science, and iterative testing, not establishing ground truth for a training set in the AI sense.

Summary of Device Evaluation Approach:

The submission for B1P Adhesive relies on a predicate device comparison and bench testing to demonstrate substantial equivalence. The key evidence provided includes:

• Biocompatibility: Conformance to ISO 10993 standards.
• Technological Characteristics Comparison: Detailed descriptions of similarities and differences with three legally marketed predicate devices, highlighting how B1P Adhesive functions similarly for the same intended use.
• Bench Testing Data: Evaluation of direct and indirect bonding strengths, confirming performance characteristics comparable to the predicate devices (though specific quantitative results are not included in the summary).

Crucially, the document explicitly states: "Clinical testing has not been conducted on this product." This means the demonstration of substantial equivalence is entirely based on non-clinical data and comparison to existing products.

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Build-It Total Core is indicated for use as a core build up material on vital and non-vital teeth, sealing root canal openings, cavity floor liner, post cementation, restorative material and dentin replacement material.

Build-It Total Core is a dual-cure, self-adhesive composite with a continuous fluoride release. Build-It Total Core utilizes 4-MET technology to adhere to dentin and cut enamel without a separate bonding agent. Ideal flow characteristics, esthetic and contrast shades, and outstanding physical properties make Build-It Total Core an indispensable tool in every clinician's armamentarium.

The provided document describes a 510(k) submission for a dental composite material called "Build-It Total Core." It focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a clinical study.

Here's an analysis based on the information provided, addressing your specific points where applicable:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a formal table of quantitative acceptance criteria with corresponding device performance values against those criteria. Instead, it lists characteristics evaluated and states that the performance characteristics were compared to predicate devices (Build-It F.R. and Cement-It All Purpose).

Explanation of "Acceptance Criteria (Implicit)": Since this is a 510(k) submission demonstrating substantial equivalence, the "acceptance criteria" for these performance characteristics are implicitly met if the test results for Build-It Total Core are similar to or equivalent to the legally marketed predicate devices. The document does not provide the specific numerical values for these characteristics for either the new device or the predicates.

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

• Sample Size: The document mentions "bench testing used to evaluate performance characteristics" but does not specify the sample sizes used for any of the tests (water absorption, solubility, flexural strength, etc.).
• Data Provenance: The data is from "bench testing," implying in-vitro testing conducted by the manufacturer, Sybron Dental Specialties, Inc. The country of origin of the data is not explicitly stated, but given the submitter's address in California, USA, it's likely U.S.-based. This is retrospective in the sense that the testing was performed to support the 510(k) submission for a finished device.

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

This question is not applicable to this type of submission. The "ground truth" for the performance characteristics measured (e.g., flexural strength) is established by standardized test methods and calibrated equipment, not by expert consensus on, for example, diagnostic images.

4. Adjudication Method for the Test Set

This question is not applicable as there's no diagnostic or interpretive element requiring expert adjudication.

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 question is not applicable. This submission is for a dental material, not an AI-powered diagnostic device, and therefore no MRMC study was performed.

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

This question is not applicable. This submission is for a dental material, not an algorithm, so no standalone algorithm performance study was done.

7. The Type of Ground Truth Used

For the biocompatibility study, the ground truth is established through standardized biological evaluations as outlined in relevant standards (e.g., ISO 10993 series), leading to a conclusion of safety for intended use.

For the bench testing performance characteristics (flexural strength, bond strength, etc.), the "ground truth" is the measured physical properties of the material under controlled laboratory conditions, obtained through validated test methods.

8. The Sample Size for the Training Set

This question is not applicable. This is not an AI/machine learning device, so there is no "training set." The product is a physical dental material.

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

This question is not applicable as there is no training set for this device.

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Build-It Light Cure is a translucent, light activated composite material designed for core build ups. It is used as core-building material on vital teeth as well as on non-vital teeth, in combination with or without a dental post. It may also be used as a final restorative filling material.

Build-It light Cure is a line extension to the current two-component dual curable Build-If FR core material. It is available in a translucent shade only. The depth of cure of the material is > 7 mm to facilitate the bulk is available in a tallslucein silade only. The depart of on the resin mixture and the fillers are immy. The combination of the material dalbarumborosilicate glasses with a little sodium fluoride. The cosonially the connecter of the material facilitates easy adaption to the tooth.

The provided K091512 document is a 510(k) summary for a dental restorative material called "Build-It Light Cure." It primarily focuses on demonstrating substantial equivalence to a predicate device and does not contain information about specific acceptance criteria or a detailed study proving the device meets quantified performance benchmarks.

The document discusses the device's technical characteristics, its intended use, and its equivalence to an existing device (Clearfil Photo Core). It does not present data from a study designed to evaluate the performance against predefined acceptance criteria for attributes like cure depth, strength, or other material properties.

Therefore, I cannot provide the requested information. The document focuses on regulatory submission and equivalence rather than a detailed performance study with acceptance criteria.

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RM Bond Adhesive product is indicated for orthodontic applications using an indirect bonding treatment technique.

The subject device is a light-cured resin adhesive in a methacrylate-based formulation; the light curing feature provides the clinician appropriate flexibility for bracket placement working-time considerations. Product is supplied as refills in a variety of delivery systems; multi-use bottle or syringe as well as a single dose delivery system.

This document is a 510(k) summary for a dental adhesive (RM Bond Adhesive) and does not contain the detailed study information typically found in a clinical trial report or a performance study. The provided text indicates that the device is substantially equivalent to a predicate device but does not include acceptance criteria, performance data, or study methodologies that would allow for a comprehensive answer to your questions.

Therefore, I cannot provide the requested table or detailed information on sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies. The content is focused on regulatory submission for substantial equivalence, not on a detailed scientific or clinical study report.

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Generation 8 SE Adhesive product is indicated for direct bonding of composite and compomer materials to enamel and dentin. Additionally, device use is appropriate for adhesive bonding of other dental materials, such as composite material to ceramics, composite material to composite material and composite material to metals and amalgam.

The subject device is a light-cured self-etching, self-priming adhesive in a solvent-free resin formulation. The Generation 8 SE Adhesive performs the etching/priming/bonding process as a single step once the restorative site has been properly prepared. Device composition is approximately 40% filler by weight with filler particle size values less than 2 microns. As with other resin products manufactured by Pentron Clinical Technologies, LLC., the predominant filler for Generation 8 SE Adhesive is a barium borosilicate glass. This filler type provides the subject device with the required strength and radiopacity features. Product is supplied as refills in a variety of delivery systems; multi-use bottle or syringe as well as a single dose delivery system.

The given text is a 510(k) summary for the "Generation 8 SE Adhesive" device. It describes the device, its intended use, and states that a review for safety and effectiveness was performed and found not to have been affected. However, it does not contain specific acceptance criteria, detailed study results, or information about sample sizes, ground truth establishment, or expert involvement as requested in your prompt.

The document states: "A review for safety and effectiveness was performed and found not to have been affected." This is a general statement and does not provide quantifiable acceptance criteria or the specific performance metrics of the device as would be presented in a formal study report.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and the reported device performance: The document does not specify quantitative acceptance criteria or detailed performance data.
2. Sample sized used for the test set and the data provenance: This information is not present.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not present.
4. Adjudication method: This information is not present.
5. Multi reader multi case (MRMC) comparative effectiveness study: This information is not present. The document focuses on substantial equivalence to a predicate device, not a comparative effectiveness study with human readers.
6. Standalone performance: While the document implies the device performs an intended function, it does not provide detailed standalone performance metrics or studies.
7. Type of ground truth used: This information is not present.
8. Sample size for the training set: This information is not present.
9. How the ground truth for the training set was established: This information is not present.

The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device (One Coat SE Bond, K033760) based on intended function, composition, and general performance, rather than presenting a detailed study with specific acceptance criteria and performance data.

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Artiste SE Flowable Composite product is a self-etch, self-adhesive flowable resin composite indicated for light-cured dental restorations. Applications include:

• Self-etch base liner
• Restorations of carious lesions
• Class 1, III, and V cavity preparations
• Pit and fissure sealant.

The subject device is a light-cured self-etching, self-adhesive composite in a BisGMA-free resin formulation. The Artiste SE Flowable Composite requires no application of etchant, primer or adhesive prior to device use once the restorative site has been properly prepared. Device composition is approximately 65% filler by weight with filler particle size values less than 2 microns. As with other resin products manufactured by Pentron Clinical Technologies, LLC., the predominant filler for Artiste SE Flowable Composite is a barium boro-silicate glass. This filler type provides the subject device with the required strength and radiopacity features. Product is supplied in various shades either in multi-use syringe or single dose delivery systems. Product packaging includes kit or refill configuration.

The provided text does not contain detailed information about specific acceptance criteria and the results of a study designed to prove the device meets those criteria. The document is a 510(k) summary for the Artiste SE Flowable Composite, focused on establishing substantial equivalence to a predicate device, rather than presenting a performance study with acceptance criteria.

Therefore, I cannot populate the table or answer the other questions based on the provided text. The document states: "A review for safety and effectiveness was performed and found not to have been affected," which is a general statement about the review, not a detailed description of a performance study with defined acceptance criteria.

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Nano-Bond II Adhesive System is used for the adhesion of dentin 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.

Nano-Bond II Adhesive System is a light-cured, reinforced dentin bonding agent. It is provided in a kit containing two components, Nano-Bond Self-Etch Primer and Nano-Bond II Adhesive and an optional component, Nano-Bond II Dual Cure Activator. The components also are available individually as refills.

This document describes a 510(k) premarket notification for the "Nano-Bond II Adhesive System". This submission is for a dental adhesive, not an AI/ML powered device. As such, the information you've requested regarding AI/ML device performance criteria, studies, and data provenance is not applicable to this 510(k) submission.

The document focuses on demonstrating substantial equivalence to a predicate device ("Nano Bond (Bond-3 Adhesive) (K020499)") based on intended use and design principles. It does not contain sections on acceptance criteria in the context of diagnostic performance metrics, details of clinical study design with human readers, ground truth establishment, or sample sizes for training/test sets as would be relevant for an AI/ML medical device.

Therefore, I cannot extract the requested information because it is not present in the provided text, which pertains to a traditional dental adhesive system.

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