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MARK3 is an irreversible hydrocolloid dental impression material used by the dentist for taking impressions of the oral cavity with the purpose of constructing a gypsum cast that is a copy of the situation in the mouth. It is a general purpose impression materials for making study models, first impressions for the construction of individual trays, situation models, orthodontic impressions.

MARK3 alginate impression material is a dust free alginate impression material with a creamy consistency for general dental practice and for orthodontics. It is presented in the form of a homogeneous pink colored powder with nice mint flavor. The material has exceptional good elastic properties and a high tear-resistance. The impression surface is smooth, which gives excellent gypsum compatibility

The provided document describes the MARK3 Alginate Impression Material (K141092) and its performance data. Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: Not explicitly stated in the provided document. The document simply states "Performance Data" and lists "Complies" for each parameter without indicating the number of samples tested for each physical property.
• Data Provenance: Not explicitly stated. It is implied that the testing was conducted by Cavex Holland BV, given the nature of the submission. The origin (e.g., country) of the specific data is not mentioned, nor is a retrospective or prospective study design.

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

• This type of information is not applicable to this submission. The device is an impression material, and its performance criteria are based on physical properties defined by industry standards (ADA18 Requirements), not on expert interpretations of medical images or patient outcomes. Therefore, no experts were used to establish "ground truth" in the clinical sense for this type of device.

4. Adjudication method for the test set:

• This is not applicable as the evaluation is based on objective physical measurements against established standards, not on subjective interpretations requiring 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 is not applicable. The device is an alginate impression material, a physical product, not an AI-assisted diagnostic or therapeutic tool. Therefore, no MRMC study or AI assistance evaluation was performed.

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

• This is not applicable. The device is a physical impression material, not an algorithm.

7. The type of ground truth used:

• The "ground truth" for evaluating the MARK3 Alginate Impression Material is based on pre-established physical and mechanical property requirements specified by the ADA18 standard. These are objective measurements rather than expert consensus on clinical findings or pathological outcomes.

8. The sample size for the training set:

• This is not applicable. This is a physical product, not a machine learning model, so there is no concept of a "training set" for model development.

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

• This is not applicable for the same reason as above.

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PROVISA CEM is intended for the cementation of temporary crowns and bridges. PROVISA CEM is free of eugenol. After its removal, it will also not inhibit the polymerisation of a composite cement or composite filling material.

PROVISA CEM is a dental cement and is particularly intended for the cementation of temporary crowns and bridges. Such a temporary prosthesis is a necessity for the patient in the period between the preparation of the tooth (or teeth) stump, followed by the impression taking, and the placement and cementation of the final prosthesis. During this period of one week or more, the prepared tooth stump has to be protected against any damage. But also the occlusal relationship of the tooth stump versus neighbouring and antagonist teeth has to be kept unchanged in order to prevent articulation problems upon placing the final prosthesis. A temporary cement should offer sufficient retentive force to keep the temporary prosthesis in situ during the intervening week(s), but at the same time it should enable the dentist to take the prosthesis off without damaging the tooth stump and with no discomfort for the patient. PROVISA CEM is presented in the form of two pastes: a white paste, containing zincand magnesium oxide as the reactive components and a yellow paste, containing fatty acid dimer as the reactive component. Upon mixing homogeneously, controlled by a uniform light yellow colour, a smooth paste with the correct consistency is formed, that can be pressed into a thin, but sufficiently strong cement layer. Through a reaction between the metallic oxides and the fatty acid dimer, a chelatenetwork is formed, that makes the paste harden. The resulting cement is stable and strong enough but not too strong.

The provided text describes a dental cement, PROVISA CEM, and its 510(k) clearance. However, it does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

The document is a 510(k) submission summary and an FDA clearance letter. These documents focus on establishing substantial equivalence to a predicate device and confirming the device's intended use and regulatory classification. They do not typically include detailed performance study results or specific acceptance criteria for the device itself.

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

The text primarily details:

• Device Name: PROVISA CEM
• Intended Use: Cementation of temporary crowns and bridges.
• Key Feature: Eugenol-free, does not inhibit polymerization of composite cements/filling materials.
• Composition: Two pastes (white with zinc and magnesium oxide, yellow with fatty acid dimer) that form a chelate network upon mixing.
• Regulatory Information: Product Code EMB, Regulation Number 21 CFR 872.3275, Regulatory Class I.
• 510(k) Number: K073539

Without information on performance specifications or a dedicated study, the requested details cannot be extracted.

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ImprEssix, Colorchange Alginate is a dental impression material based on alginate. It is used for taking impressions of the oral cavity with the purpose of constructing a gypsum cast that is a copy of the situation in the mouth. It is a general purpose impression material for making study models, first impressions for the construction of individual trays, situation models, orthodontic impressions etc.

ImprEssix, Colorchange Alginate is a dental impression material based on alginate.

The provided text is an FDA 510(k) clearance letter for the ImprEssix, Colorchange Alginate Impression Materials. It confirms that the device is substantially equivalent to legally marketed predicate devices.

However, this document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment relevant to an AI/machine learning device.

The questions posed (e.g., about multi-reader multi-case studies, standalone algorithm performance, training set size, etc.) are typical for the evaluation of AI or machine learning-based medical devices, which this product demonstrably is not. The ImprEssix material is a conventional dental impression material.

Therefore, I cannot answer the questions based on the provided text. To answer these questions, a document detailing the clinical validation or performance study of an AI/machine learning device would be required.

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Simulate, Color Change Alginate is a dental impression material based on alginate. It is used for taking impressions of the oral cavity with the purpose of constructing a gypsum cast that is a copy of the situation in the mouth. It is a general purpose impression material for making study models, first impressions for the construction of individual trays, situation models, orthodontic impressions etc.

Simulate, Color Change Alginate has the special characteristic of being a colorchanging alginate: it becomes violet upon contact with water in the mixing bowl, changes to pink indicating the end of the mixing time and then finally changes to white indicating the end of the setting time in the mouth.

Simulate, Color Change Alginate is a dental impression material based on alginate. It has the special characteristic of being a colorchanging alginate: it becomes violet upon contact with water in the mixing bowl, changes to pink indicating the end of the mixing time and then finally changes to white indicating the end of the setting time in the mouth.

I am sorry, but the provided text is a 510(k) clearance letter from the FDA. This document does not contain any information about acceptance criteria or a study proving device performance.

A 510(k) clearance letter indicates that the FDA has determined a new medical device is substantially equivalent to a legally marketed predicate device. It primarily focuses on the regulatory approval process, product classification, and general controls the manufacturer must adhere to.

To answer your request, I would need a different type of document, such as:

• A clinical trial report
• A validation study protocol or report
• A scientific publication detailing the device's performance evaluation
• The 510(k) submission itself (which often includes such data, but is not the clearance letter)

Without such a document, I cannot extract the information you've requested.

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ImprEssix alginate impression material is a dental impression material based on alginate. It is used for taking impressions of the oral cavity with the purpose of constructing a gypsum cast that is a copy of the situation in the mouth. ImprEssix has an extra fast setting time, high elasticity, high tear resistance, can be poured twice with gypsum and is presented in a attractive fuchsia-coloured powder with a red-fruit flavour. Therefore, ImprEssix is particularly suited for orthodontics

ImprEssix alginate impression material is a dental impression material based on alginate. It is used for taking impressions of the oral cavity with the purpose of constructing a gypsum cast that is a copy of the situation in the mouth. ImprEssix has an extra fast setting time, high elasticity, high tear resistance, can be poured twice with gypsum and is presented in a attractive fuchsia-coloured powder with a red-fruit flavour.

The provided text is an FDA 510(k) clearance letter for a medical device called "ImprEssix Alginate Impression Material." This letter is a regulatory document and does not contain information about acceptance criteria or a study proving the device meets those criteria.

The 510(k) clearance process focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than requiring extensive clinical trials to establish new performance metrics. Therefore, the detailed information requested in your prompt (acceptance criteria, specific study designs, sample sizes, expert qualifications, etc.) is typically not part of this type of regulatory document.

To directly answer your prompt based on the provided text, I must state that the information is not available within the document.

Here's a breakdown of why each specific point cannot be addressed from the given text:

1. A table of acceptance criteria and the reported device performance: Not present. The letter mentions characteristics like "extra fast setting time, high elasticity, high tear resistance, can be poured twice with gypsum," but these are descriptive features, not quantitative acceptance criteria with reported performance data from a study.
2. Sample size used for the test set and the data provenance: Not present. No study details are provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present. No study details are provided.
4. Adjudication method for the test set: Not present. No study details are provided.
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 alginate impression material, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is an alginate impression material, not an algorithm.
7. The type of ground truth used: Not present. No study details are provided.
8. The sample size for the training set: Not applicable. This device is an alginate impression material, not a machine learning model requiring a training set.
9. How the ground truth for the training set was established: Not applicable. This device is an alginate impression material, not a machine learning modelrequiring a training set.

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Cavex Orthotrace alginate impression material is a dental impression material based on alginate. It is about taking impressions of the oral cavity with the purpose of constituting a gypsum cast that is a copy of the situation in the mouth. Cavex Orthotrace has an extra fast setting, high elasticity, high tear resistance, can be poured twice with gypsum and is proven Orthotrace is particularly suited for orthodontics

Cavex Orthotrace Alginate impression material

I am sorry, but the provided text does not contain the information required to describe the acceptance criteria and the study that proves the device meets the acceptance criteria. The document is a 510(k) clearance letter from the FDA for a dental impression material named "Cavex Orthotrace," dated June 21, 2005. It confirms the device's substantial equivalence to legally marketed predicate devices.

The letter details the regulatory classification, general controls provisions of the Act, and contact information for further inquiries. However, it does not include any technical specifications, performance data, clinical study results, or information about acceptance criteria or how they were met. It merely states that the device is substantially equivalent for the indications for use.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, or details about study characteristics like sample size, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies, as this information is absent in the provided text.

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Quadrant Uni-1-Bond is a light curing, single component bonding agent for universal use in combination with adhesive restorations. Quadrant Uni-1-Bond primes and bonds in one step. Quadrant Uni-1-Bond is an ethanol-based formulation of lightactivated, adhesive resins.

Quadrant Uni-1-Bond is a light curing, single component bonding agent for universal use in combination with adhesive restorations. Quadrant Uni-1-Bond primes and bonds in one step. Quadrant Uni-1-Bond is an ethanol-based formulation of lightactivated, adhesive resins.

The provided text is a 510(k) clearance letter from the FDA for a dental bonding agent, Quadrant Uni-1-Bond. It does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, ground truth types, or training set details. This type of document primarily confirms that the device is substantially equivalent to a legally marketed predicate device, allowing it to be marketed.

Therefore, I cannot extract the requested information from the provided text.

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Tulip Colorswitch is a dental impression material based on alginate. It is used for taking impressions of the oral cavity with the purpose of constructing a gypsum cast that is a copy of the situation in the mouth. It is a general purpose impression material for making study models, first impressions for the construction of individual trays, situation models, orthodontic impressions etc.

Tulip Colorswitch is a dental impression material based on alginate. Tulip Colorswitch has the special characteristic of being a color-changing alginate: it becomes violet upon contact with water in the mixing bowl, changes to pink indicating the end of the mixing time and then finally changes to white indicating the end of the setting time in the mouth.

The provided text describes a 510(k) premarket notification for a dental impression material, "Tulip Colorswitch Alginate Impression Materials" (K032116), and the FDA's determination of substantial equivalence to a predicate device. However, this document does not contain any information about acceptance criteria or a study that proves the device meets specific performance criteria.

The FDA letter and the "Indications for Use" statement focus on regulatory approval based on substantial equivalence, general controls, and the intended use of the device. There is no mention of specific numerical performance metrics, clinical study design, sample sizes, ground truth establishment, or expert evaluations.

Therefore, I cannot provide the requested information. The document itself is a regulatory approval letter, not a performance study report.

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Tulip Alginate impression material is a dental impression material based on alginate. It is used for taking impressions of the oral cavity with the purpose of constructing a gypsum cast that is a copy of the situation in the mouth. It is a general purpose impression material for making study models, first impressions for the construction of individual trays, situation models, orthodontic impressions etc.

Tulip Alginate impression material is a dental impression material based on alginate.

The provided text is a 510(k) clearance letter from the FDA for a dental impression material named "Tulip Alginate Impression Material." This document does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth methodologies that would be typically associated with an AI/ML device or a complex diagnostic medical device.

The letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976..."

This indicates that the clearance was based on demonstrating substantial equivalence to existing predicate devices, rather than a de novo clinical study with specific acceptance criteria and detailed performance metrics as would be required for novel or high-risk devices.

Therefore, I cannot provide the requested information from the given text. The text does not describe a study proving the device meets acceptance criteria in the manner you've outlined.

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