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Provicol QM Plus is intended for use as:

• · Temporary cementation of provisional restorations (crowns, bridges, inlays and onlays)
• . Temporary cementation of definitive restorations (crowns, bridges, inlays and onlays)

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I am sorry, but the provided text does not contain information about the acceptance criteria or a study proving that a device meets such criteria. The document is an FDA letter regarding a 510(k) premarket notification for a dental cement called "Provicol QM Plus." It states that the device is substantially equivalent to legally marketed predicate devices and outlines general regulatory compliance requirements for the manufacturer. It also includes the indications for use statement for the device.

Therefore, I cannot provide the requested information, including the table of acceptance criteria, sample sizes, expert qualifications, study types, or ground truth details, as this information is not present in the given text.

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The Dentist In A Box™ Dental Emergency Kit Plus Tooth Trauma Care Kit provides immediate, temporary relief from common dental problems, accidents and trauma until a dentist can be seen. For use by trained professionals.

For temporary relief from a lost filling, chipped tooth, or irritation by orthodontic wire or denture clasp or for temporary stabilization of a loosened or knocked out permanent tooth. Used by persons in remote areas such as during military field service when access to a dentist or dental equipment and facilities are not available for an extended period of time and effective treatment is necessary to prevent discomfort or delay in treatment may aggravate the injury.

Dentist In A Box intends to assemble U.S. FDA regulatory cleared and/or exempt devices into a convenience kit for the U.S. market.

The kit components are either (1) legally marketed pre-Amendments devices, (2) exempt from premarket notification (consistent with the exemption criteria described in the classification regulation(s) and the limitation of exemptions for Section 510(k) of the act (e.g., 862.9), or (3) have been found to be substantially equivalent through the premarket notification process for the use(s) for which the kit is to be intended (i.e., not claiming or causing a new use for the component(s)).

The components are purchased in finished form, i.e., they are packaged, labeled, etc., consistent with their pre-Amendments, exemption, or premarket notification criteria and status.

Components:
Hand-held mouth mirror
Sterile Cotton-tipped swabs
Temporary filling material
Tooth splinting material
Sterile unbuffered Saline Solution 0.9%, 5ml unit dose
Sterile Disposable gloves

The provided text describes a 510(k) submission for a convenience kit, not a study evaluating a device's performance or acceptance criteria in the manner requested. The submission is for the "Dentist In A Box™ Dental Emergency Kit Plus Tooth Trauma Care Kit".

Therefore, I cannot extract the information you requested about acceptance criteria and a study proving device performance because no such study was performed or is referenced in the provided text.

Here's why and what the document does provide:

• No Clinical Study/Non-Clinical Test Summaries: The document explicitly states "Non-Clinical Test Summaries: N/A" and "Clinical Study Summary: N/A". This means no studies were conducted to assess the performance of the kit as a whole or its individual components beyond their existing regulatory status.
• Substantial Equivalence: The basis for this 510(k) clearance is "substantial equivalence" to a predicate device (Cavit-W temporary crown and bridge resin K875133) for the only Class II device component in the kit, and the fact that other components are either pre-Amendments, exempt, or previously cleared devices.
• Convenience Kit: The device is a "convenience kit," an assembly of already cleared or exempt devices. The regulatory approach for such kits often focuses on the components' individual clearances and the kit's intended use not introducing new questions of safety or effectiveness.

To directly answer your numbered requests based on the provided text, using "N/A" where the information is not present:

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

   Acceptance Criteria	Reported Device Performance
   N/A	N/A
   (The submission does not present specific performance criteria or data, as it relies on substantial equivalence of its components.)

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

   • Sample Size (Test Set): N/A (No test set mentioned)
   • Data Provenance: N/A (No data from a test set mentioned)

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):

   • Number of Experts: N/A
   • Qualifications of Experts: N/A

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

   • Adjudication Method: N/A

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:

   • MRMC Study Done: No.
   • Effect Size: N/A

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

   • Standalone Performance Study: No.

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

   • Type of Ground Truth: N/A

8. The sample size for the training set:

   • Sample Size (Training Set): N/A

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

   • Ground Truth Establishment: N/A

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TempoCem is a dental luting agent indicated for:

• . temporary cementation of provisional crowns and bridges
• cementing of semi-permanent implants .

TempoCem is a temporary cement based on zinc oxide / eugenol for automatic mixing. Its low film thickness provides an exceptional fit. TempoCem combines reliable adhesion with easy and clean removal. Excess can be removed easily. TempoCem is offered in different varieties.

The provided text describes a 510(k) premarket notification for a dental temporary cement called TempoCem. The information focuses on regulatory approval based on substantial equivalence to predicate devices and adherence to an international standard.

Based on the provided text, the following information regarding acceptance criteria and a study proving the device meets these criteria can be extracted or inferred:

1. Table of Acceptance Criteria and Reported Device Performance:

The primary acceptance criteria for TempoCem, as stated, is that it "meets the requirements of ISO Equivalenoo in i romanto roude/eugenol and zinc oxide/non-eugenol cements - Third Edition." The text does not provide a table with specific numerical acceptance criteria from this ISO standard nor specific reported performance values for TempoCem against these criteria.

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

The document mentions that the submission is an "Abbreviated 510(k) as described in FDA's guidance document entitled 'The New 510(k) Paradigm - Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications.'" This typically means that new clinical data or extensive performance data might not be required if the device is substantially equivalent to a legally marketed predicate and adheres to recognized standards.

• Sample Size for Test Set: Not specified. The document implies compliance with an ISO standard rather than a specific clinical trial with a defined test set sample size.
• Data Provenance: Not specified. The compliance is with an "ISO" standard, which is an international standard, but the location where the tests were conducted or the origin of any data (if external to the standard's methodology) is not mentioned. It is highly likely the data is from in vitro laboratory testing to demonstrate compliance with the standard. The study is not a retrospective or prospective clinical study in the traditional sense described in the context of device performance in humans.

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

This information is not applicable and not provided. The device's substantial equivalence is based on meeting an ISO standard for dental cements and comparison to predicate devices, not on expert-adjudicated ground truth from a test set of patient data.

4. Adjudication Method for the Test Set:

This information is not applicable and not provided. As above, the evaluation is based on compliance with an ISO standard, not a human reader or expert adjudication process.

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

An MRMC study was not done. The approval is for a dental cement, not an imaging or diagnostic device that would typically involve human readers.

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

This concept is not applicable to this device. TempoCem is a physical dental cement, not an algorithm or AI system. Its performance is intrinsic to the material properties.

7. Type of Ground Truth Used:

The "ground truth" here is compliance with an international standard (ISO Equivalenoo in i romanto roude/eugenol and zinc oxide/non-eugenol cements - Third Edition). This standard likely sets forth methodologies and acceptable ranges for various physical and chemical properties of dental cements.

8. Sample Size for the Training Set:

This information is not applicable and not provided. As TempoCem is a manufactured product and not an AI/ML algorithm, there is no "training set" in the context of data science or machine learning.

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

This information is not applicable and not provided. There is no ground truth for a training set in this context.

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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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for cementing temporary crowns, bridges, and other restorations as well as for trial cementing permanent restorations

Not Found

The provided document is a 510(k) premarket notification letter from the FDA for a dental cement device. It does not contain any information about acceptance criteria, device performance, study details, or ground truth related to an AI/ML medical device. The letter confirms that the device, "NON-EUGENOL TEMPORARY CEMENT," is substantially equivalent to legally marketed predicate devices.

Therefore, I cannot provide the requested information. The document pertains to a traditional medical device (dental cement) and not a software-driven or AI-enabled device.

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