LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K153067
    Device Name
    Tubli-Seal, Tubli-Seal EWT,Tubli-Seal Xpress, Tubli-Seal EWT Xpress
    Manufacturer
    SYBRON DENTAL SPECIALTIES
    Date Cleared
    2016-07-27

    (279 days)

    Product Code
    KIF
    Regulation Number
    872.3820
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K942393
    Why did this record match?
    Device Name :

    Tubli-Seal, Tubli-Seal EWT,Tubli-Seal Xpress, Tubli-Seal EWT Xpress

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

    The Tubli-Seal product line (Tubli-Seal Xpress/Tubli-Seal EWT/Tubli-Seal EWT Xpress) is used for permanent obturation of the root canal space with the aid of obturating points.

    Device Description

    The Tubli-Seal product line (Tubli-Seal Xpress/ Tubli-Seal EWT/ Tubli-Seal EWT Xpress) is a Zinc Oxide Eugenol root canal sealer to be used for permanent obturation of the root canal space in conjunction with obturating points. It is a two-part, base/accelerator, paste/paste system that is mixed in equal portions. Then the mixture is carried to the root canal with endodontic obturation points, or directly dispensed in the root canal depending on delivery method, e.g. tube or dual-barrel syringe. The product is available in two (2) working times. Regular and Extended Work Time (EWT) for both delivery options of tubes or dual-barrel syringes.

    The proposed is available packaged in tubes (Tubli-Seal and Tubli-Seal EWT) and dualbarrel syringes (Tubli-Seal Xpress and Tubli-Seal EWT Xpress) used with single-use automix tips. The tubes are dispensed onto a mixing pad, hand mixed and then applied to the canal with an endodontic point. Tubli-Seal Xpress has the same formulation and indications for use as Tubli-Seal, and Tubli-Seal EWT Xpress has the same formulation and indications for use as Tubli-Seal EWT. The proposed syringe-delivery products are branded as "Tubli-Seal Xpress" and "Tubli-Seal EWT Xpress" and offer the convenience of single-use automix tips that remove the need for hand mixing. The dual-barrel and single-use automix tips allow the dental professional to deliver the desired volume of Tubli-Seal Xpress or Tubli-Seal EWT Xpress directly into the prepped root canal.

    AI/ML Overview

    Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets those criteria:

    Device: Tubli-Seal product line (Tubli-Seal/Tubli-Seal Xpress/Tubli-Seal EWT/Tubli-Seal EWT Xpress)

    This submission is for a modified version of an existing root canal sealer (Tubli-Seal/Tubli-Seal EWT). The core of the study is to demonstrate that the modified product line is substantially equivalent to the predicate device, essentially performing as well despite minor formula changes and a manufacturing location change.

    1. A table of acceptance criteria and the reported device performance

    The acceptance criteria are based on the international standard ISO 6876:2012 for Dental - Root Canal Sealing Materials. The reported performance of the proposed device is compared to the predicate device, with the standard as the overarching acceptance benchmark.

    Criterion (ISO 6876:2012)Predicate Device PerformanceProposed Device PerformanceAcceptance Criteria (from ISO 6876:2012)Does Proposed Device Meet Criteria?
    Consistency (Flow)29 mm28 mmNot explicitly stated in the provided text as a numerical range (for a pass/fail), but is a characteristic measured. The slight difference (1mm) is considered acceptable for substantial equivalence.Yes (implicitly, as considered substantially equivalent)
    Film Thickness13.04 µm17.61 µmNot more than 50 µmYes (17.61 µm
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1