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510(k) Data Aggregation

    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
    Why did this record match?
    Applicant Name (Manufacturer) :

    1Derful, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    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.
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