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510(k) Data Aggregation

    K Number
    K213244
    Device Name
    Accusil Dental Impression Materials (Accusil Light Body Regular and Fast Set, Accusil Heavy Body Regular and Fast Set, Accusil Monophase Regular and Fast Set, Accusil Putty Regular and Fast Set, Accusil Bite Registration)
    Manufacturer
    Prevest Denpro Limited
    Date Cleared
    2022-09-09

    (344 days)

    Product Code
    ELW
    Regulation Number
    872.3660
    Type
    Traditional
    Panel
    Dental Devices (DE)
    Reference & Predicate Devices
    K053427,K220097,K152861,K171562
    Why did this record match?
    Reference Devices :

    K053427, K220097, K152861

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

    Accusil Dental Impression Material is intended to be placed on a preformed impression tray and used to reproduce the structure of a patient's teeth and gums.

    Device Description

    Accusil Dental Impression Materials are designed for dental applications to define and reproduce the structure of a patient's teeth and gums for producing crowns, bridges, occlusal models and dental implant restorative devices. Base and catalyst components are mixed in an equal ratio 1:1, placed into an impression tray and inserted into the patient's mouth. The material will conform to the patient's dentition and when set will produce a reproduction of the patient's teeth and occlusion.

    AI/ML Overview

    The document describes the acceptance criteria and performance of Accusil Dental Impression Materials as part of a 510(k) premarket notification for FDA clearance.

    Here's an analysis of the provided information, structured according to your request:

    1. Table of Acceptance Criteria and Reported Device Performance:

    The document indicates that Accusil Dental Impression Materials were tested against specific ISO standards (ISO 4823 and ISO 48-4) and internal protocols. The "Acceptance Criteria" are implicitly derived from the requirements of these standards. The "Reported Device Performance" for Accusil is provided in the comparative table with predicate and reference devices.

    Performance CharacteristicAccusil Dental Impression Materials (Reported Performance)Acceptance Criteria (Implicit from ISO standards and comparison with predicate/references)
    Working/Processing Time40-150 secSimilar to predicate (90 sec) and reference devices (35-120 sec).
    Setting time/Time in the mouth60-300 secSimilar to predicate (90 sec) and reference devices (120-330 sec).
    Hardness63-70 Shore ASimilar to predicate (46-70 Shore A) and reference devices (42-75 Shore A).
    Working Humidity50%Matches predicate (50%).
    Dimensional Accuracy99.9%-99.2%Similar to predicate (99.9%-99.2%) and reference devices (98%-99.9%).
    Stability (Linear Dimensional Change)
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