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510(k) Data Aggregation

    K Number
    K222061
    Device Name
    Dental LT Clear V2 Resin
    Manufacturer
    Formlabs Ohio, Inc.
    Date Cleared
    2022-11-10

    (120 days)

    Product Code
    MQC,DYT,KMY
    Regulation Number
    N/A
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K203000,K183598
    Why did this record match?
    Device Name :

    Dental LT Clear V2 Resin

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

    Dental Clear LT V2 Resin when utilized to print dental or orthodontic appliances such as occlusal splints, night guards, or mouth guards is indicated to treat patients diagnosed with Temporomandibular Joint Disorders (TMD) and/or Bruxism, respectively.

    Device Description

    Dental LT Clear V2 Resin is a light-curable polymer-based resin designed for the fabrication of biocompatible, long-term use, removable dental and orthodontic appliances by additive manufacturing.

    AI/ML Overview

    The provided document describes the acceptance criteria and the study that proves the device meets the acceptance criteria for Dental LT Clear V2 Resin, a light-curable polymer-based resin for fabricating dental and orthodontic appliances.

    Here's a breakdown of the requested information:

    1. Table of Acceptance Criteria and Reported Device Performance

    The non-clinical testing data for the Dental LT Clear V2 Resin is summarized in Table 1 on page 4 of the document.

    Technological / Performance CharacteristicTest MethodAcceptance CriteriaPost Cured Results
    Flexural modulusASTM D790-17≥ 1 GPa≥ 2000 MPa
    Ultimate tensile strengthASTM D638-14≥ 35 MPa≥ 50 MPa
    ElongationASTM D638-14≥ 0.8 %≥ 10%
    Hardness Shore DASTM D2240-15Compliant to ASTM D2240-1578D
    Water SorptionISO 20795-2
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