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    K Number
    K210884
    Device Name
    1Derful HS, 1Derful HT
    Manufacturer
    1Derful, Inc
    Date Cleared
    2021-07-27

    (124 days)

    Product Code
    EIH
    Regulation Number
    872.6660
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K130991
    Why did this record match?
    Applicant Name (Manufacturer) :

    1Derful, Inc

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

    1Derful™ Zirconia blanks are indicated for use in prosthetic dentistry to create porcelain (ceramic) prostheses (dentures, crowns and bridges) in the anterior applications and not used solely as an implant. 1Derful™ Zirconia blanks are intended to be milled and fully sintered by Dental Professional or Dental Laboratory before use.

    Device Description

    1Derful™ Zirconia are disc shaped dental porcelain zirconia oxide blanks that come in various sizes that are used in custom restorations by the dental laboratory. The dental laboratory will further process the blank by milling the blank based upon the anatomically rendering of the patient's teeth (done at the dental office) through "Computer Aided Drafting/ Computer Aided Machining (CAD/CAM). Once the custom rendered blank is milled the product is fully sintered and colored (if required) and fitted to the patient's teeth as dentures, crowns or bridges. 1Derful™ Zirconia blanks are composed of zirconia ceramics (ZrO2) based on yttria- stabilized tetragonal zirconia (Y-TZP). Shading oxide will also be used to create the need shade in the disc. These three oxide materials are Fe2O3, ErO3, Co3O4 & Er2O3.

    AI/ML Overview

    The provided text describes the non-clinical testing performed for the 1DERFUL™ HS & 1DERFUL™ HT Zirconia blanks. It does not mention any clinical studies, multi-reader multi-case studies, or human-in-the-loop performance. Therefore, information regarding those aspects cannot be extracted.

    Here's a breakdown of the requested information based on the provided text:

    1. Table of Acceptance Criteria and Reported Device Performance

    Test/PropertyAcceptance Criteria (Standard Requirement)Reported Device Performance (1DERFUL™ HS & 1DERFUL™ HT)Outcome
    Flexural Strength Test per ISO 6872:2015 Section 7.3Minimum (mean) 800 MPa for class 6 fixed prostheses, lowest value> 1000 MPaPass
    Freedom from extraneous materials per ISO 6872:2015 Section 5.2 active conc. of not more than 1.0 Bq g-1 of Uranium238
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