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510(k) Data Aggregation

    K Number
    K201915
    Device Name
    GenesisZr 4Y+ (ST1100) Zirconia
    Date Cleared
    2021-02-23

    (228 days)

    Product Code
    Regulation Number
    872.6660
    Why did this record match?
    Applicant Name (Manufacturer) :

    United Dental Resources Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    GenesisZr® 4Y+(ST1100) Zirconia blanks are indicated for use by dental technicians for the production of full contour and substructures restorations up to a full arch.
    Device Description
    GenesisZr® 4Y+ (ST1100) Zirconia are disc and block 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 a crown, bridge or coping.
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    K Number
    K201608
    Device Name
    GenesisZr UHT700 Zirconia
    Date Cleared
    2021-01-28

    (227 days)

    Product Code
    Regulation Number
    872.6660
    Why did this record match?
    Applicant Name (Manufacturer) :

    United Dental Resources Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    GenesisZr® UHT700 Zirconia blanks are indicated for Monolitic-ceramic for single-unit anterior or posterior prostleses and for three-unit prostheses not involving molar restoration, adhesively cemented. Also indicated for fully covered substructure for single-unit anterior or posterior prostheses and for three-unit prostheses not involving molar restoration_adhesively, or non-adhesively cemented.
    Device Description
    GenesisZr® UHT700 Zirconia are disc and block 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 a crown.
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    K Number
    K182642
    Device Name
    GenesisZr™ 4Y Zirconia
    Date Cleared
    2019-01-25

    (123 days)

    Product Code
    Regulation Number
    872.6660
    Why did this record match?
    Applicant Name (Manufacturer) :

    United Dental Resources Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    GenesisZr™ 4Y Zirconia blanks are indicated for use in prosthetic dentistry to create porcelain (ceramic) prostheses (dentures, crowns and bridges). GenesisZr™ 4Y Zirconia blanks are intended to be milled and fully sintered before use for: - Full contour monolithic crowns and bridges in anterior and posterior regions. - Anatomically reduced for veneering, crown and bridge frames. - Bridge to be limited to 3 units with a maximum of 1 pontic.
    Device Description
    GenesisZr™ 4Y Zirconia are disc shaped dental porcelain zirconia oxide blanks that come in one color, white, and various sizes that are used in customized 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 customized rendered blank is milled the device is fully sintered and colored (if required) and fitted to the patient's teeth as dentures, crowns or bridges.
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    K Number
    K060377
    Device Name
    DR DISPOSABLE PROPHY ANGLE MODEL H310
    Manufacturer
    Date Cleared
    2006-04-26

    (71 days)

    Product Code
    Regulation Number
    872.4200
    Why did this record match?
    Applicant Name (Manufacturer) :

    DENTAL RESOURCES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The DR Disposable Prophy Angle is a device intended to be attached to a low speed dental handpiece and used by professional dentists and dental hygienists for polishing and cleaning the surface of teeth. The DR Disposable Prophy Angle is intended for single use, thus eliminating the possibility of cross contamination.
    Device Description
    The DR Disposable Prophy Angle is a dental device that consists of a pair of gears, a turning spindle and a drive spindle enclosed in a plastic housing, that connects to a low speed dental handpiece. The turning spindle has a prophylaxis cup attached to the end which holds dental tooth polishing paste.
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