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510(k) Data Aggregation

    K Number
    K191306
    Device Name
    Llis, Vittra APS
    Manufacturer
    Date Cleared
    2019-12-16

    (216 days)

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

    Llis, Vittra APS

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

    The Llis and VITTRA APS composite is suitable for use in:

    • Direct restorations in anterior and posterior teeth (I, II, III, IV, V e VI);
    • Core build-ups;
    • Teeth splinting;
    • Indirect restorations such as inlays, onlays and veneers.
    • Direct veneers with composites;
    • Restoration of deciduous teeth
    • Diastema closing or reduction;
    • Modification of teeth's shape (e.g .: conoid teeth);
    • Cementation of tooth fragments;
    • Porcelain/composite repairs:
    Device Description

    Llis is a radiopaque composite for anterior and posterior restorations. Its composition was based in modern concepts so that methacrylate monomers, silanes and fillers with adequate size distribution were combined to produce a product with differentiated physical, mechanical and optical properties. Llis presents a simplified shade system, offering enamel, dentin and incisal shades.

    Vittra APS is a highly aesthetic light-curing composite resin recommended for restorations of all classes in anterior and posterior teeth. The composite is radiopaque; its loading particles are composed by spheres of a zirconia complex with average load particle size of 200nm, with total inorganic load of 72% to 82% in weight (52% to 60% in volume). Those characteristics contribute to enhance both mechanical and aesthetic properties, especially evidenced by how easy it is to obtain proper polishing and by the long-lasting surface shining. Vittra APS' formula is free of Bis-GMA and Bis-EMA, following the present trend of products free of Bisphenol A (BPA).

    APS is the acronym for Advanced Polymerization System, and it consists of a combination of different photoinitiators that interact among each other amplifying the curing capacity of light emitted from light-curing units. Added to different materials, the system provides different advantages.

    In the case of Vittra APS, APS adds as main benefit the reduction or elimination of visual shade and opacity alteration before/after light curing, which enhances the predictability of the result. Another factor is that, although there is very little concentration of camphorquinone - that has a yellowish aspect - APS has great power of polymerization allowing greater degree of conversion. The APS system is activated by any type of lightcuring unit available on the market, even those with less power or narrow range of wavelength.

    AI/ML Overview

    The Dentscare LTDA Llis and VITTRA APS devices are tooth shade resin materials. The provided text outlines the acceptance criteria and study results for these devices.

    Acceptance Criteria and Device Performance (Llis and Vittra APS)

    The acceptance criteria are generally defined by compliance with ISO 4049 (Dentistry - Polymer-based restorative materials) and in some cases, by comparison to commercially available, internationally recognized quality composites.

    TestAcceptance CriteriaReported Device Performance
    Llis
    Sensitivity to environment lightingPhysical homogeneity after testing, with no difference compared to material pressed between coverslips without ambient light exposure (ISO 4049).All results are within the range specified by ISO 4049.
    Depth of Cure> 1.0 mm for opaque materials and > 1.5 mm for non-opaque materials (ISO 4049).All results are greater than the specified threshold, conforming to the standard. (Llis: 2.44 mm; Vittra APS: 2.43 mm reported in Section J. The individual test result for Vittra APS is also stated as "All results are greater than the specified threshold").
    Color tone stability after radiation and water absorptionNo more than a small change in color, and three observers with normal vision identify no differences in color after visual inspection at 200-300 mm distance for
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