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510(k) Data Aggregation

    K Number
    K082591
    Device Name
    FLEXITIME BITE
    Manufacturer
    HERAEUS KULZER, INC., DENTAL PRODUCTS DIVISION
    Date Cleared
    2008-12-05

    (88 days)

    Product Code
    ELW
    Regulation Number
    872.3660
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    HERAEUS KULZER, INC., DENTAL PRODUCTS DIVISION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    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.

    Device Description

    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.

    AI/ML Overview

    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:

    Acceptance Criteria CategorySpecific Acceptance CriteriaReported Device Performance
    Material PropertiesCompliance with ISO 13903Meets the requirements of ISO 13903 and functional specification for D 922.
    BiocompatibilityCompliance with EN ISO 10993-1Verified in accordance with international standard. Documented in a Biological Evaluation Report. Benefit-risk outweighed possible risks with the new catalyst.
    Toxicological EvaluationAssessment of possible risks and recommendations for warningsToxicological expert opinions carried out to assess risks and evaluate recommendations. These were incorporated into the instruction for use and clinical evaluation.
    Clinical PerformanceExpected performance and effectiveness for bite registration materialRepresents a well-known type of bite registration material proven to exhibit expected performance and clinical effectiveness.
    SafetyNo undesirable effects or potential risks when applied according to instructionsNo hint for undesirable effects and potential risks when Flexitime Bite is applied according to instructions for use.
    Risk AnalysisAcceptable risk according to EN ISO 14971Risk analysis showed acceptable risk when applied according to manufacturer's instructions.
    Overall Regulatory ComplianceMeets relevant requirements of European Medical Device Directive 93/42/EEC and national medical device legislationMeets all relevant requirements.
    Effectiveness and Safety ConclusionConsidered effective and safe when used according to manufacturer's informationConcluded to be effective and safe.

    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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