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510(k) Data Aggregation

    K Number
    K103339
    Device Name
    TDS ABUTMENT FOR FRIADENT XIVE
    Manufacturer
    POU YU BIOTECHNOLOGY CO., LTD.
    Date Cleared
    2011-03-31

    (136 days)

    Product Code
    NHA, CLA
    Regulation Number
    872.3630
    Why did this record match?
    Applicant Name (Manufacturer) :

    POU YU BIOTECHNOLOGY CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    TDS Abutment for Friadent Xive is intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient. This device is compatible with the following implant systems which have an internal hex with flat-to-flat dimensions of 1.78mm or greater: Firadent: FRIALIT Implant, XiVA Implant; 3i: Internal Connect Type; Astra: Osseospeed Implant, Osseospeed TX Implant; BioHorizons: Internal Implant System, Tapered Internal Implant System, Single-Stage Implant System, Laser-lok® 3.0 implant system; Lifecore: Lifecore RENOVA™ Internal Hex Implant System; Zimmer: Tapered Screw-Vent Implant System, Screw-Vent Implant System, AdVent Implant System; Osstem: GS System; Nobel Biocare: Active Implant.
    Device Description
    TDS Abutment for Friadent Xive are titanium and ceramic-titanium abutments designed to be used in conjunction with specific dental implants utilizing the TDS Abutment screw, which is made of Ti-6A1-4V ELI titanium and is used to secure the abutment to the implant. In combination with the implant, the abutments support single or multi-unit cement-retained restorations in the maxillary and/or mandibular arch. TDS Abutment for Friadent Xive is compatible with the following implant systems which have an internal hex with flat-to-flat dimensions of 1.78mm or greater: Firadent: FRIALIT Implant, XiVA Implant; 3i: Internal Connect Type; Astra: Osseospeed Implant, Osseospeed TX Implant; BirHorizons: Internal Implant System, Tapered Internal Implant System, Single-Stage Implant System, Laser-lok 3.0 implant system; Lifecore: Lifecore RENOVA™ Internal Hex Implant System; Zimmer: Tapered Screw-Vent Implant System, Screw-Vent Implant System, AdVent Implant System; Osstem: GS System; Nobel Biocare: Active Impalnt.
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    K Number
    K100356
    Device Name
    TDS PRECISION DENTAL BAR
    Manufacturer
    POU YU BIOTECHNOLOGY CO., LTD.
    Date Cleared
    2010-10-05

    (235 days)

    Product Code
    NHA
    Regulation Number
    872.3630
    Why did this record match?
    Applicant Name (Manufacturer) :

    POU YU BIOTECHNOLOGY CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    TDS Precision Dental Bars are indicated for use with dental implants as a prosthetic framework to support and/or retain removable or fixed dental prostheses in the treatment of partially or totally edentulous jaws to restore chewing function. The abutment screws are intended to secure the bar to the endosseous implants.
    Device Description
    TDS Precision Dental Bars are prosthetic frameworks and made of machined titanium, zirconia-titanium, and zirconia materials. They are connected with dental implants utilizing the TDS screw which is made of Ti-6A1-4V ELI (Extra Low Interstitial) alloy. TDS Precision Dental Bars are fabricated individually following instructions to each patient and serve to support and/or retain fixed dental prosthesis or removable dental prosthesis. They are compatible with dental implants manufactured by NobelBiocare, Camlog, BIOMET 3i, Zimmer, Lifecore, Astra, BioHorizons, Straumann, Dentsply Friadent, and Osstem.
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    K Number
    K091392
    Device Name
    TDS TITANIUM ABUTMENT FOR NOBEL BIOCARE BRANEMARK
    Manufacturer
    POU YU BIOTECHNOLOGY CO., LTD.
    Date Cleared
    2009-07-30

    (80 days)

    Product Code
    NHA, CLA
    Regulation Number
    872.3630
    Why did this record match?
    Applicant Name (Manufacturer) :

    POU YU BIOTECHNOLOGY CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    TDS Titanium Abutment for Nobel Biocare Branemark is intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient. This device is compatible with the following implant systems which have an external hex with flat-to-flat dimensions of 2.4mm or greater: Nobel Biocare: Branemark System® Mk III Groovy, Branemark System® Mk III Shorty, Branemark System® Zygoma, NobelSpeedy Groovy, NobelSpeedy Shorty; 3i: Nano Tite External Hex Connection Implants, Full OSSEOTITE External Hex Connection Implants, OSSEOTITE External Hex Connection Implant; BioHorizons: Maestro - External Hex Implants; Lifecore: Restore External Hex Implant Systems.
    Device Description
    TDS Titanium Abutment for Nobel Biocare Branemark are titanium abutments made of Ti-6A1-4V ELI titanium designed to be used in conjunction with specific dental implants utilizing the TDS Abutment screw, which is also made of Ti-6A1-4V ELI titanium and is used to secure the abutment to the implant. In combination with the abutments support single or multi-unit cement-retained restorations in the maxillary and/or mandibular arch. TDS Titanium Abutment for Nobel Biocare Branemark is compatible with the following implant systems which have an external hex with flat-to-flat dimensions of 2.4mm or greater: Nobel Biocare Branemark, 3i, BioHorizons, and Lifecore.
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    K Number
    K091693
    Device Name
    TDS ZIRCONIA ABUTMENT FOR NOBEL BIOCARE BRANEMARK
    Manufacturer
    POU YU BIOTECHNOLOGY CO., LTD.
    Date Cleared
    2009-07-30

    (50 days)

    Product Code
    NHA, CLA
    Regulation Number
    872.3630
    Why did this record match?
    Applicant Name (Manufacturer) :

    POU YU BIOTECHNOLOGY CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    TDS Zirconia Abutment for Nobel Biocare Branemark is intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient. This device is compatible with the following implant systems which have an external hex with flat-to-flat dimensions of 2.4mm or greater: Nobel Biocare: Branemark System® Mk III Groovy, Branemark System® Mk III Shorty, Branemark System® Zygoma, NobelSpeedy Groovy, NobelSpeedy Shorty; 3i: Nano Tite External Hex Connection Implants, Full OSSEOTITE External Hex Connection Implants, OSSEOTITE External Hex Connection Implant; BioHorizons: Maestro - External Hex Implants; Lifecore: Restore External Hex Implant Systems.
    Device Description
    TDS Zirconia Abutment for Nobel Biocare Branemark are zirconia abutments made of yttria-stabilized zircona (Y-TZP) designed to be used in conjunction with specific dental implants utilizing the TDS Abutment screw, which is made of Ti-6A1-4V ELI titanium and is used to secure the abutment to the implant. In combination with the implant, the abutments support single or multi-unit cement-retained restorations in the maxillary and/or mandibular arch. TDS Zirconia Abutment for Nobel Biocare Branemark is compatible with the following implant systems which have an external hex with flat-to-flat dimensions of 2.4mm or greater: Nobel Biocare Branemark, 3i, BioHorizons, and Lifecore.
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    K Number
    K091026
    Device Name
    TDS ABUTMENT FOR NOBEL BIOCARE REPLACE
    Manufacturer
    POU YU BIOTECHNOLOGY CO., LTD.
    Date Cleared
    2009-06-24

    (75 days)

    Product Code
    NHA, CLA
    Regulation Number
    872.3630
    Why did this record match?
    Applicant Name (Manufacturer) :

    POU YU BIOTECHNOLOGY CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    TDS Abutment for Nobel Biocare Replace is intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient. TDS Abutment for Nobel Biocare Replace is compatible with the following implant systems: Nobel Replace® Select Straight, Nobel Replace Select Straight One Stage, Replace Select Tapered and Replace Select Tapered One Stage, Nobel Replace Straight, Nobel Replace Tapered, Nobel Replace Straight Groovy, and Nobel Replace Tapered Groovy for the 3.5 mm (NP), 4.3 mm (RP), 5.0 mm (WP) and 6.0 mm (WP) implants. Note: Highly angled abutments (i.e. 30°) on implants with diameters less than 4 mm are not intended for the posterior region of the mouth due to limited strength of the implant.
    Device Description
    TDS Abutment for Nobel Biocare Replace are titanium and ceramic-titanium abutments designed to be used in conjunction with specific dental implants utilizing the TDS Abutment screw, which is made of Ti-6A1-V ELI titanium and is used to secure the abutment to the implant. In combination with the implant, the abutments support single or multi-unit cement-retained restorations in the maxillary and/or mandibular arch. TDS Abutment for Nobel Biocare Replace are compatible with Nobel Replace® Select Straight, Nobel Replace Select Straight One Stage, Replace Select Tapered and Replace Select Tapered One Stage, Nobel Replace Straight, Nobel Replace Tapered, Nobel Replace Straight Groovy, and Nobel Replace Tapered Groovy for the 3.5 mm (NP), 4.3 mm (RP), 5.0 mm (WP) and 6.0 mm (WP) implants.
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    K Number
    K081460
    Device Name
    TDS ABUTMENT
    Manufacturer
    POU YU BIOTECHNOLOGY CO., LTD.
    Date Cleared
    2008-11-21

    (182 days)

    Product Code
    NHA, CLA
    Regulation Number
    872.3630
    Why did this record match?
    Applicant Name (Manufacturer) :

    POU YU BIOTECHNOLOGY CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    TDS Abutment is intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient.
    Device Description
    TDS Abutments are custom titanium or ceramic abutments designed to be used in conjunction with specific dental implants utilizing the screw provided by the implant manufacturer. In combination with the implant, the abutments support single or multi-unit cement-retained restorations in the maxillary and/or mandibular arch. TDS Abutments made of titanium are available for Nobel Biocare Replace® RP (Ø 4.3 mm) implants. TDS Abutments made of ceramic are available for Nobel Biocare Replace® WP (Ø 5.0 mm) implants and BioHorizons Internal 4.0 (Ø 4.5 mm platform) implants.
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