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510(k) Data Aggregation

    K Number
    K214118
    Device Name
    Riva Cem Automix
    Manufacturer
    SDI Limited
    Date Cleared
    2022-08-30

    (243 days)

    Product Code
    EMA
    Regulation Number
    872.3275
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K111185,K182854
    Why did this record match?
    Device Name :

    Riva Cem Automix

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

    Permanent cementation of:

      1. Porcelain fused to metal (PFM) to crowns and bridges
      1. Prefabricated/cast posts
      1. Metals to crowns, bridges, inlays & onlays, orthodontic appliances & posts
      1. Ceramics (high strength)* to crowns & bridges, inlays & onlays
    • *E.g. Zirconia, Lithium Disilicate,
      1. Ceramics (low strength)* to inlays
    • *E.g. Feldspathic porcelains, Glass ceramics
    Device Description

    Riva Cem Automix™ is a radiopaque, fluoride releasing, resin modified glass ionomer luting cement.

    Riva Cem Automix™ is intended for the cementation of crowns, bridges, inlays, posts (fibre-reinforced), and orthodontic appliances.

    Riva Cem Automix™ consists of a base paste and a catalyst paste packaged in the automix delivery system for direct delivery in consistent mix ratios. Riva Cem Automix™ is available in a universal light-yellow shade in a double barrel syringe. The automix tip offers convenience over traditional hand mixed systems.

    The product provides both self-cure and tack cure mechanisms which makes it versatile for the cementation of different restorative systems.

    AI/ML Overview

    The provided text is a 510(k) premarket notification for a dental cement called "Riva Cem Automix." It focuses on demonstrating substantial equivalence to predicate devices through bench testing and biocompatibility testing, rather than an AI-powered diagnostic device. Therefore, it does not contain the information requested regarding acceptance criteria and a study proving an AI device meets those criteria.

    Specifically, the document lacks information on:

    1. Acceptance criteria for an AI device and reported device performance: The document details acceptance criteria and performance for a dental cement, focusing on physical and chemical properties like working time, setting time, film thickness, flexural strength, radio-opacity, shear bond strength, and fluoride release. These are not acceptance criteria for an AI device.
    2. Sample size for a test set and data provenance: No AI test set is mentioned. The "performance data" section refers to in-vitro bench tests for a physical product.
    3. Number of experts and their qualifications for ground truth: Not applicable as it's not an AI device study requiring human expert labeling of data.
    4. Adjudication method for the test set: Not applicable.
    5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not conducted as it's not an AI device study.
    6. Standalone (algorithm-only) performance: Not applicable.
    7. Type of ground truth used: For the dental cement, the ground truth is established by standardized laboratory testing methods (e.g., ISO standards) measuring physical and chemical properties, not expert consensus or pathology on images.
    8. Sample size for the training set: Not applicable as no AI training set is mentioned.
    9. How ground truth for the training set was established: Not applicable.

    In summary, the provided document describes the regulatory approval of a dental cement, not an AI medical device.

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