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Flexitime Light Flow/Flexitime Medium Flow each is an addition-cross-linking polyvinyl siloxane impression material for all inlay, crown and bridge, edentulous and partial impressions.

Dental Impression Material

The provided text is related to a 510(k) premarket notification for a dental impression material (Flexitime Light Flow / Medium Flow). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a study with acceptance criteria and device performance in the manner typically associated with clinical trials or AI/software validation.

Therefore, the requested information elements (1-9) which pertain to acceptance criteria, specific study designs, sample sizes, expert ground truth, adjudication methods, and AI performance metrics are not applicable to this 510(k) submission.

The document states:

• "No performance standards have been established for this type of device."
• "The results of device performance testing demonstrated that it is suitable for use as an impression material, Flexitime Flow has been designed and manufactured to perform in a manner substantially equivalent to that of the predicate devices."

This indicates that the focus was on demonstrating that the new device performs similarly to existing, approved devices, rather than meeting specific quantifiable performance criteria through a rigorous study as described in your request. Comparisons would typically involve physical and chemical properties relevant to dental impressions, but the details of such tests are not provided in this excerpt.

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Used for standards bite registrations in the end bite position Coating of bite forks Key material for needle point registration Production of small model segments.

The product is developed under the project name D 922. Flexitime bite is a scannable polyvinyl siloxane for bite registration with superior hardness and a very short application time in mouth. Its surface properties and optimised colour enable it to be optically recorded in CAD/CAM systems to portray the antagonists. Flexitime Bite can be scanned in the Heraeus scanner and many other CAD/CAM systems.

This is a premarket notification for a dental impression material, not an AI/ML device, so many of the requested categories (e.g., sample size for test set, number of experts, MRMC studies, training set details) are not applicable. The provided document details the safety and effectiveness of "Flexitime Bite," a scannable polyvinyl siloxane for bite registration.

1. Table of Acceptance Criteria and Reported Device Performance:

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

Not applicable. This is a material science and biocompatibility assessment, not a study evaluating algorithm performance on a dataset. The evaluation is based on standardized material testing, toxicological assessments, and a clinical evaluation report.

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

• Biocompatibility: The biocompatibility was documented in a "Biological Evaluation Report (Biocompatibility) for Flexitime Bite (Hecker, Troesken, 19. May 2008)". The qualifications of Hecker and Troesken are not specified, but they are identified as authors of an official report.
• Toxicological Opinions: "Toxicological expert opinions are carried out to assess possible risks." The number and specific qualifications of these experts are not provided.
• Clinical Evaluation: A "clinical evaluation report according to MEDDEV 2.7.1. for Flexitime Bite" was conducted by "Hecker, 06.06.2008." The specific qualifications of Hecker are not detailed beyond being the author of this report.

4. Adjudication Method for the Test Set:

Not applicable. This is not a study requiring adjudication of diagnostic interpretations. The assessments involve standardized tests, expert review of data, and regulatory compliance.

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

No. This is not an AI/ML device and therefore no MRMC study was conducted.

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

Not applicable. This device is a dental material, not an algorithm.

7. The Type of Ground Truth Used:

The ground truth is established through:

• Standardized Material Testing: Compliance with international standards such as ISO 13903 for physical properties.
• Biocompatibility Standards: Compliance with EN ISO 10993-1.
• Toxicological Assessment: Expert opinions based on scientific principles of toxicology.
• Clinical Evaluation: Assessment against expected performance and clinical effectiveness for this type of material.
• Risk Analysis: Compliance with EN ISO 14971.

8. The Sample Size for the Training Set:

Not applicable. This is not an AI/ML device and does not involve training data.

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

Not applicable. This is not an AI/ML device and does not involve a training set.

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Bonding of direct composite restorations (including Polyglas® and Compomer) .
Bonding of indirect restoration in combination with a light-curing luting cement . Porcelain, Polyglas®, and composite restorations (inlays, onlays, veneers, rowns).
Sealing hypersensitive areas of teeth. .

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I apologize, but the provided text from the FDA 510(k) clearance letter for the HKBond 2006 device does not contain the detailed information necessary to answer your request regarding acceptance criteria and a study proving the device meets those criteria.

The 510(k) letter primarily addresses:

• Substantial equivalence determination: It states that the FDA has determined the device is substantially equivalent to legally marketed predicate devices. This implies that the new device performs as well as, or is as safe and effective as, existing devices for the stated indications.
• Regulatory information: It outlines the regulation number, regulation name, and product code.
• Indications for Use: It specifies how the device is intended to be used (bonding direct composite restorations, bonding indirect restorations, and sealing hypersensitive areas of teeth).
• Compliance requirements: It reminds the manufacturer of various regulatory requirements they must adhere to.

Missing Information:

The document does not include:

1. A table of acceptance criteria and reported device performance: While the equivalence determination implies performance is comparable, specific metrics and targets are not given.
2. Sample size and data provenance for a test set: There's no mention of a specific study or test set details.
3. Number and qualifications of experts for ground truth: No information about expert involvement in a study.
4. Adjudication method: Not discussed.
5. MRMC comparative effectiveness study: No mention of such a study or effect size.
6. Standalone performance study: Not explicitly detailed.
7. Type of ground truth used: Not specified.
8. Sample size for the training set: Not applicable for this type of medical device clearance, as it's not an AI/ML device that undergoes model training in the typical sense.
9. How ground truth for the training set was established: See point 8.

For a medical device like HKBond 2006 (a resin tooth bonding agent), the "study" proving it meets acceptance criteria would typically involve bench testing (e.g., bond strength, fluoride release, cytotoxicity), material characterization, and potentially clinical evaluations (though often not full-scale trials for 510(k) clearance when substantial equivalence to a well-understood predicate is established). The acceptance criteria for these tests would be based on recognized standards and predicate device performance, but these details are not present in this FDA letter.

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Mondial line is synthetic polymer teeth for the fabrication of full and partial dentures. The enamel and dentine layers of HK teeth are highly cross-linked and suit the rate of natural abrasion. The base of the tooth is less cross-linked to achieve optimum bonding between the tooth and the denture acrylic.

Mondial line is synthetic polymer teeth for the fabrication of full and partial dentures. The enamel and dentine layers of HK teeth are highly cross-linked and suit the rate of natural abrasion. The base of the tooth is less cross-linked to achieve optimum bonding between the tooth and the denture acrylic.

The provided text is an FDA 510(k) clearance letter for a dental device called "Mondial" (preformed plastic denture tooth). This type of document declares substantial equivalence to a predicate device and does not contain the kind of detailed study information requested in your prompt.

Therefore, I cannot provide the information you've asked for, such as:

• A table of acceptance criteria and the reported device performance: This document does not describe performance metrics or acceptance criteria.
• Sample size used for the test set and the data provenance: Not present.
• Number of experts used to establish the ground truth for the test set and their qualifications: Not present.
• Adjudication method for the test set: Not present.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: Not present, as this typically applies to AI-assisted diagnostic devices.
• If a standalone performance (algorithm only) was done: Not present.
• The type of ground truth used: Not present.
• The sample size for the training set: Not present.
• How the ground truth for the training set was established: Not present.

This letter solely confirms that the "Mondial" denture teeth are substantially equivalent to previously marketed devices and are cleared for marketing based on their intended use in the fabrication of full and partial dentures. The "study" referenced in 510(k) submissions typically refers to non-clinical tests (e.g., material properties, dimensional stability) or comparisons to predicate devices, rather than clinical efficacy studies with human subjects that would generate the data you're asking about for AI/diagnostic devices.

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HeraCeram Zirkonia dental ceramic compound is intended for use with the rieraeona crown and bridge framework made of zirconia.

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I am sorry, but based on the provided document, I cannot extract the information required to describe the acceptance criteria and the study that proves the device meets those criteria.

The document is a US FDA 510(k) clearance letter for a dental ceramic product called "HeraCeram Zirkonia." This letter primarily addresses the substantial equivalence of the device to a legally marketed predicate device and outlines regulatory requirements. It does not contain:

• A table of acceptance criteria or reported device performance.
• Details about sample sizes for test sets or their data provenance.
• Information on experts used to establish ground truth.
• Adjudication methods.
• Results of any Multi-Reader Multi-Case (MRMC) comparative effectiveness studies.
• Information about standalone algorithm performance.
• The type of ground truth used (e.g., pathology, outcomes data).
• Sample sizes for training sets and how their ground truth was established.

These types of details would typically be found in the 510(k) submission itself, which is a much more extensive document than the clearance letter provided. The clearance letter only states that the device was found "substantially equivalent" based on the information in the submission.

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PalaImpact is a heat curing, high-impact denture acrylic resin for the fabrication of full and partial dentures. PalaImpact is also used for fixed and removable prosthetics devices.

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This document is a 510(k) clearance letter for a dental device, not a study report. Therefore, it does not contain the information required to answer the questions about acceptance criteria, study design, and performance. The letter simply states that the FDA has found the device, "Palaimpact®", to be substantially equivalent to legally marketed devices based on the information provided in the premarket notification.

Here's why the requested information cannot be extracted:

• Acceptance Criteria and Device Performance: The letter does not list specific performance metrics or acceptance criteria for the device (e.g., strength, durability, biocompatibility) nor does it report any study results against such criteria.
• Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone Performance, Ground Truth, Training Set: These are all details typically found in a clinical or performance study report, which is not what this document is. The 510(k) process relies on demonstrating substantial equivalence, which can sometimes involve comparing the new device's specifications to those of an already cleared predicate device, or presenting data from bench testing or limited clinical studies. However, the details of those studies are not typically included in the FDA's clearance letter itself.

In summary, this document is an FDA clearance letter and not a scientific study report. As such, it does not provide the specific technical details of the device's performance evaluation.

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Versyo.direct is a light curing, methyl methacrylate free conditioner for the bonding of light curing prosthetic base materials to heat, self or light curing PMMA denture base materials and artificial teeth based on PMMA.

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I am sorry, but the provided text is a 510(k) premarket notification decision letter from the FDA for a dental bonding agent (Versyo®.direct). It does not contain any information regarding acceptance criteria or a study proving the device meets acceptance criteria.

The letter confirms the device's substantial equivalence to a predicate device based on its indications for use and regulatory classification. It outlines regulatory requirements for marketing the device but does not include details about performance studies, sample sizes, ground truth establishment, or expert reviews, which would typically be found in a submission summary or a scientific study report.

Therefore, I cannot provide the requested information.

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Flexitime Xtreme is a polyvinylsiloxane silicone impression material used for all inlay, crown and bridge, edentulous and partial impressions.

Flexitime Xtreme is a polyvinylsiloxane silicone impression material.

This document is a 510(k) clearance letter for a dental impression material, Flexitime Xtreme. It does not contain information about acceptance criteria or a study proving device performance in the context of AI/machine learning. Therefore, I cannot extract the requested information.

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Ostim is intended as a filling or reconstruction material for repair of bony defects in oral, gnathic and facial applications in the following indications:

• Filling of intraoral bony defects such as those resulting from cytectomies, tooth tip I resections, extractions or surgical tooth removal.
• Augmentations in the area of the alveolar processes and maxillary sinuses.
• Filling of periodontal defects.

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I am sorry, but the provided text does not contain information about acceptance criteria, device performance, study details, or the other specific points requested in your prompt. The document is a 510(k) clearance letter from the FDA for a bone grafting material called Ostim®, outlining its regulatory status and intended use, but it does not include a scientific study or performance data table.

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HeraCeram Press dental ceramic compound is intended for use with the veneering ceramic material HeraCeram. It can be used for full ceramic restorations with the common layering technique as well as the staining technique. Applications: Veneers, Inlays, Onlays and Crowns.

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The provided text is a 510(k) premarket notification letter from the FDA to Heraeus Kulzer, Incorporated, regarding their device "HeraCeram Press." It primarily discusses the substantial equivalence determination for this dental ceramic compound.

This document does not contain any information about acceptance criteria, device performance metrics, study designs, sample sizes, expert qualifications, ground truth establishment, or clinical study results (such as MRMC or standalone performance). The letter is a regulatory approval document and not a performance study report.

Therefore, I cannot fulfill your request for detailed information on acceptance criteria and study particulars based on the provided text.

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