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510(k) Data Aggregation

    K Number
    K052779
    Device Name
    BRECOMP
    Manufacturer
    BREDENT-PRODUCTS FOR THE DENTAL TECHNICIAN LABORAT
    Date Cleared
    2005-12-20

    (78 days)

    Product Code
    EBF
    Regulation Number
    872.3690
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K790439
    Why did this record match?
    Device Name :

    BRECOMP

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

    Bre.comp is intended to restore carious lesions or structural defects in teeth.

    Device Description

    Bre.comp dentine/enamel/transparent is a light curing microhybride for anterior and posterior restorations. Bre.comp is based on BIS-GMA resins and inorganic fillers with particle size of 0.05 to 0.09 µm. The total filler content is 81% (weight percent) and 63% (volume percent). The composite material complies with the requirements of DIN EN ISO 4049.

    Application range:
    Universal dental restorative material for the following indications:

    • cavity classes I to V
    • inlays, veneers (direct and indirect)
    • crown suprastructures
    • post and core buildups
    AI/ML Overview

    This document does not contain information about acceptance criteria or a study that proves the device meets acceptance criteria. It is a 510(k) Summary for a dental restorative material (Bre.comp) and the FDA's clearance letter.

    The document states:

    • "The presented data that was conducts shows in its results and in comparison to the predicate devices that the products are absolutely safe and effective for their intended use and do not raise any questions regarding sofety and effectiveness." (Page 2)
    • It also mentions compliance with DIN EN ISO 4049, which is a standard for dental polymer-based restorative materials.

    However, it does not provide details on:

    1. A specific table of acceptance criteria and reported device performance.
    2. Sample sizes or data provenance for any performance studies.
    3. Number or qualifications of experts for ground truth establishment.
    4. Adjudication methods.
    5. Multi-reader multi-case (MRMC) comparative effectiveness studies.
    6. Standalone performance studies with specific metrics.
    7. Type of ground truth used.
    8. Sample size for the training set.
    9. How ground truth for the training set was established.

    This document focuses on establishing substantial equivalence to a predicate device (K790439 - Vivadent (USA) Inc.) based on technical characteristics, indications for use, and general safety and effectiveness claims, rather than detailing a specific performance study with acceptance criteria.

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