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    K Number
    K220390
    Device Name
    CreoDent Solidex Customized Abutment and Screw
    Manufacturer
    CreoDent Prosthetics, Ltd.
    Date Cleared
    2022-12-02

    (294 days)

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

    CreoDent Prosthetics, Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CreoDent Solidex® Customized Abutment and Screw is intended for use with an endosseous implant to support a prosthetic device in patients who are partially or completely edentulous. The device can be used for single or multiple-unit restorations. The prosthesis can be cemented, or screw retained to the abutment. An abutment screw is used to secure the abutment to the endosseous implant. CreoDent Solidex Customized Abutments and Screws to be compatible with the Implant Direct InterActive/Swish Active 3.0mm implants are only indicated for single-tooth replacement of mandibular central and lateral incisors and maxillary lateral incisors.
    Device Description
    The Solidex® Customized Abutment and Screw is Ti-6A1-4V Eli titanium alloy meets ASTM F-136 standard and is designed to be screw retained for use with endosseous dental implants to provide support for a prosthetic restoration. These abutments are indicated for cement or screw retained restorations. Solidex® Customized Abutment and Screw are compatible with: | Manufacturer | Implant Line | Platform<br>Diameter<br>(mm) | Implant<br>Body<br>Diameter<br>(mm) | Max<br>Diameter | Wall<br>Thickness<br>(mm) | Height<br>Min/Max<br>(mm) | Post<br>Height<br>Min/Max<br>(mm) | Collar<br>Height<br>Min/Max<br>(mm) | Angulation<br>Min/Max<br>(Degress) | |-------------------------------|--------------|------------------------------|-------------------------------------|--------------------------------|---------------------------|---------------------------|-----------------------------------|-------------------------------------|------------------------------------| | Neodent<br>Implant<br>Systems | GM Line | 3.5/3.75 | 3.5/3.75 | 5mm<br>from<br>Implant<br>Axis | .68 | 5 - 10 | 4 - 9 | 1 - 5 | 0 - 20 | | Manufacturer | Implant Line | Platform<br>Diameter<br>(mm) | Implant<br>Body<br>Diameter<br>(mm) | Max<br>Diameter | Wall<br>Thickness<br>(mm) | Height<br>Min/Max<br>(mm) | Post<br>Height<br>Min/Max<br>(mm) | Collar<br>Height<br>Min/Max<br>(mm) | Angulation<br>Min/Max<br>(Degress) | | Implant Direct<br>Sybron<br>Manufacturing<br>LLC | 2014<br>InterActive/SwishActive<br>System | 3.0 | 3.0 | 5mm<br>from<br>Implant<br>Axis | .68 | 5 - 10 | 4 - 9 | 1 - 5 | 0 - 20 | The design of subject device is customized to the requirements of each patient as may be specified by the prescribing dentist. Customization is limited by the minimum dimensions for wall thickness, diameter, height, collar height and angulation.
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    K Number
    K202909
    Device Name
    CreoDent Solidex Customized Abutment
    Manufacturer
    CreoDent Prosthetics, Ltd.
    Date Cleared
    2021-04-02

    (185 days)

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

    CreoDent Prosthetics, Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CreoDent Solidex® Customized Abutment and screw is intended for use with an endosseous implant to support a prosthetic device in patients who are partially or completely edentulous. The device can be used for single or multiple restorations. The prosthesis can be cemented or screw retained to the abutment screw is used to secure the abutment to the endosseous implant. The CreoDent Solidex® Customized Abutment is compatible with the following dental implants: | Manufacturer | Implant Line | Platform<br>Diameter (mm) | Implant Body<br>Diameter (mm) | |------------------------------------------|-----------------------------------------------|---------------------------|-------------------------------| | Altatec Biotechnolgies N.A. Incorporated | Camlog Screwline Implant Promote | 3.3 | 3.3 | | Altatec Biotechnolgies N.A. Incorporated | Camlog Screwline Implant Promote | 3.8 | 3.8 | | Altatec Biotechnolgies N.A. Incorporated | Camlog Screwline Implant Promote | 4.3 | 4.3 | | Altatec Biotechnolgies N.A. Incorporated | Camlog Screwline Implant Promote | 5.0 | 5.0 | | Astra Tech, Inc | Osseospeed TX Implants | 3.5 | 3.5 | | Astra Tech, Inc | Osseospeed TX Implants | 4.5 | 4.5 | | Biomet | 3i Osseotite Certain Dental Implants | 3.4 | 3.25 | | Biomet | 3i Osseotite Certain Dental Implants | 4.1 | 4.0 | | Biomet | 3i Osseotite Certain Dental Implants | 5.0 | 5.0 | | Biomet | 3i Osseotite Certain Dental Implants | 6.0 | 6.0 | | Dentium CO., Ltd | Dentium 3.6mm Implantium | 3.6 | 3.4 | | Hiossen | Hiossen TS Implants | 3.5 (Mini) | 3.5 | | Hiossen | Hiossen TS Implants | 4.0 (Regular) | 4.0 | | Lifecore Biomedical, Inc | PrimaConnex Implants Internal (KeyStone) | 3.5 | 2.4 | | Lifecore Biomedical, Inc | PrimaConnex Implants Internal (KeyStone) | 4.1 | 2.7 | | Lifecore Biomedical, Inc | PrimaConnex Implants Internal (KeyStone) | 5.0 | 3.3 | | Nobel Biocare | NobelActive™ Internal Connection Implant | 3.5 (NP) | 3.5 | | Nobel Biocare | NobelActive™ Internal Connection Implant | 3.9 (RP) | 4.3 | | Nobel Biocare | NobelReplace™ TiUnite Endosseous Implant | 3.5 (NP) | 3.5 | | Nobel Biocare | NobelReplace™ TiUnite Endosseous Implant | 4.3, 5.0 (RP) | 4.3, 5.0 | | Thommen Medical AG | SPI Element Dental Implants RC INCELL PF | 3.5 | 3.5 | | Thommen Medical AG | SPI Element Dental Implants RC INCELL PF | 4.0 | 4.0 | | Thommen Medical AG | SPI Element Dental Implants RC INCELL PF | 4.5 | 4.2 | | Thommen Medical AG | SPI Element Dental Implants RC INCELL PF | 5.0 | 5.0 | | Thommen Medical AG | SPI Element Dental Implants RC INCELL PF | 6.0 | 6.0 | | Straumann | Straumann Bone Level (BL) Implants | 3.3 (NC) | 3.3 | | Straumann | Straumann Bone Level (BL) Implants | 4.1, 4.8 (RC) | 4.1, 4.8 | | Zimmer | Zimmer Screw-Vent, Tapered Screw-Vent Implant | 3.5 | 3.7 | | Zimmer | Zimmer Screw-Vent, Tapered Screw-Vent Implant | 4.5 | 4.7 | | Zimmer | Zimmer Tapered Screw-Vent Implant | 5.7 | 6.0 | All digitally designed files for CreoDent Solidex® Customized Abutment are to be sent back to a CreoDent-validated manufacturing facility for manufacture.
    Device Description
    The CreoDent Solidex® Customized Abutment is fabricated of Ti-6AL-4V ELI titanium alloy meeting the requirements of ASTM F136 or Commercially Pure (CP Ti) titanium meeting the requirements of ASTM F67 (Grade 04-06). The CreoDent Solidex® Customized Abutment retention screws are fabricated of Ti-6AL-4V ELI titanium alloy meeting the requirements of ASTM F136 or Commercially Pure (CP Ti) titanium meeting the requirements of ASTM F67 (Grade 04-06). The CreoDent Solidex® Customized Abutment is screw-retained for use with endosseous dental implants to provide support for a prosthetic restoration. These abutments are indicated for cement or screw-retained restorations. CreoDent Solidex® Customized Abutments are compatible with the following implant systems and the listed implant and restorative platform diameters: | Manufacturer | Implant Line | Platform<br>Diameter<br>(mm) | Implant Body<br>Diameter (mm) | |------------------------------------------|-----------------------------------------------|------------------------------|-------------------------------| | Altatec Biotechnolgies N.A. Incorporated | Camlog Screwline Implant Promote | 3.3 | 3.3 | | Altatec Biotechnolgies N.A. Incorporated | Camlog Screwline Implant Promote | 3.8 | 3.8 | | Altatec Biotechnolgies N.A. Incorporated | Camlog Screwline Implant Promote | 4.3 | 4.3 | | Altatec Biotechnolgies N.A. Incorporated | Camlog Screwline Implant Promote | 5.0 | 5.0 | | Astra Tech, Inc | Osseospeed TX Implants | 3.5 | 3.5 | | Astra Tech, Inc | Osseospeed TX Implants | 4.5 | 4.5 | | Biomet | 3i Osseotite Certain Dental Implants | 3.4 | 3.25 | | Biomet | 3i Osseotite Certain Dental Implants | 4.1 | 4.0 | | Biomet | 3i Osseotite Certain Dental Implants | 5.0 | 5.0 | | Biomet | 3i Osseotite Certain Dental Implants | 6.0 | 6.0 | | Dentium CO., Ltd | Dentium 3.6mm Implantium | 3.6 | 3.4 | | Hiossen | Hiossen TS Implants | 3.5 (Mini) | 3.5 | | Hiossen | Hiossen TS Implants | 4.0 (Regular) | 4.0 | | Lifecore Biomedical, Inc | PrimaConnex Implants Internal (KeyStone) | 3.5 | 2.4 | | Lifecore Biomedical, Inc | PrimaConnex Implants Internal (KeyStone) | 4.1 | 2.7 | | Lifecore Biomedical, Inc | PrimaConnex Implants Internal (KeyStone) | 5.0 | 3.3 | | Nobel Biocare | NobelActive™ Internal Connection Implant | 3.5 (NP) | 3.5 | | Nobel Biocare | NobelActive™ Internal Connection Implant | 3.9 (RP) | 4.3 | | Nobel Biocare | NobelReplace™ TiUnite Endosseous Implant | 3.5 (NP) | 3.5 | | Nobel Biocare | NobelReplace™ TiUnite Endosseous Implant | 4.3, 5.0 (RP) | 4.3, 5.0 | | Thommen Medical AG | SPI Element Dental Implants RC INCELL PF | 3.5 | 3.5 | | Thommen Medical AG | SPI Element Dental Implants RC INCELL PF | 4.0 | 4.0 | | Thommen Medical AG | SPI Element Dental Implants RC INCELL PF | 4.2 | 4.5 | | Thommen Medical AG | SPI Element Dental Implants RC INCELL PF | 5.0 | 5.0 | | Thommen Medical AG | SPI Element Dental Implants RC INCELL PF | 6.0 | 6.0 | | Straumann | Straumann Bone Level (BL) Implants | 3.3 (NC) | 3.3 | | Straumann | Straumann Bone Level (BL) Implants | 4.1, 4.8 (RC) | 4.1, 4.8 | | Zimmer | Zimmer Screw-Vent, Tapered Screw-Vent Implant | 3.5 | 3.7 | | Zimmer | Zimmer Screw-Vent, Tapered Screw-Vent Implant | 4.5 | 4.7 | | Zimmer | Zimmer Tapered Screw-Vent Implant | 5.7 | 6.0 | The design of subject device is customized to the requirements of each patient as may be specified by the prescribing dentist. Customization is limited by the minimum dimensions for wall thickness, diameter, post height, collar height and angulation. All digitally designed files for CreoDent Solidex® Customized Abutment are to be sent back to a CreoDent-validated manufacturing facility for manufacture.
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    K Number
    K202095
    Device Name
    CreoDent Solidex Customized Abutment and Screw
    Manufacturer
    CreoDent Prosthetics, Ltd.
    Date Cleared
    2020-12-16

    (140 days)

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

    CreoDent Prosthetics, Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CreoDent Solidex® Customized Abutment and Screw is intended for use with an endosseous implant to support a prosthetic device in patients who are partially or completely edentulous. The device can be used for single or multiple-unit restorations. The prosthesis can be cemented or screw retained to the abutment. An abutment screw is used to secure the abutment to the endosseous implant. The CreoDent Solidex® Customized Abutment and Screw are compatible with the following: - Straumann Tissue Level Standard Plus RN 3.3 and WN 6.5
    Device Description
    The Solidex® Customized Abutment and Screw is Ti-6A1-4V Eli titanium alloy meets ASTM F-136 standard and is designed to be screw retained for use with endosseous dental implants to provide support for a prosthetic restoration. These abutments are indicated for cement or screw retained restorations. Solidex® Customized Abutment and Screw are compatible with: - . Straumann Tissue Level Standard Plus RN 3.3 and WN 6.5 The design of subject device is customized to the requirements of each patient as may be specified by the prescribing dentist. Customization is limited by the minimum and maximum dimensions for wall thickness, diameter, height, collar height and angulation.
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    K Number
    K170100
    Device Name
    CreoDent Solidex Customized Abutment and Screw
    Manufacturer
    CreoDent Prosthetics, Ltd.
    Date Cleared
    2017-07-18

    (188 days)

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

    CreoDent Prosthetics, Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CreoDent Solidex® Customized Abutment and Screw is intended for use with an endosseous implant to support a prosthetic device in patients who are partially or completely endentulous. The device can be used for single or multiple-unit restorations. The prosthesis can be cemented or screw retained to the abutment. An abutment screw is used to secure the abutment to the endosseous implant. The CreoDent Solidex® Customized Abutment and Screw are compatible with the following: - Sweden & Martina Premium Implant System 3.3mm and 3.8mm
    Device Description
    The Solidex® Customized Abutment and Screw is Ti-6A1-4V Eli titanium alloy meets ASTM F-136 standard and is designed to be screw retained for use with endosseous dental implants to provide support for a prosthetic restoration. These abutments are indicated for cement or screw retained restorations. Solidex® Customized Abutment and Screw are compatible with: - Sweden & Martina Premium Implant System 3.3mm and 3.8mm The design of subject device is customized to the requirements of each patient as may be specified by the prescribing dentist. Customization is limited by the minimum dimensions for wall thickness, diameter, height, collar height and angulation.
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    K Number
    K162734
    Device Name
    CreoDent Solidex Customized Abutment
    Manufacturer
    CreoDent Prosthetics, Ltd.
    Date Cleared
    2017-05-08

    (220 days)

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

    CreoDent Prosthetics, Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CreoDent Solidex® Customized Abutment and Screw is intended for use with an endosseous implant to support a prosthetic device in patents who are partially or completely edentulous. The device can be used for single or multiple restorations. The prosthesis can be cemented or screw retained to the abutment. An abutment screw is used to secure the abutment to the endosseous implant.
    Device Description
    The Solidex® Customized Abutment and Screw is Ti-6A1-4V Eli titanium alloy meets ASTM F-136 standard and is designed to be screw retained for use with endosseous dental implants to provide support for a prosthetic restoration. These abutments are indicated for cement or screw retained restorations. The design of subject device is customized to the requirements of each patient as may be specified by the prescribing dentist. Customization is limited by the minimum dimensions for wall thickness, diameter, post height, collar height and angulation.
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    K Number
    K160436
    Device Name
    CreoDent Solidex Custom Abutment
    Manufacturer
    CreoDent Prosthetics, Ltd.
    Date Cleared
    2016-09-29

    (225 days)

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

    CreoDent Prosthetics, Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CreoDent Solidex® Customized Abutment is intended for use with an endosseous implant to support a prosthetic device in patients who are partially or completely endentulous. The device can be used for single or multiple-unit restorations. The prosthesis can be cemented or screw retained to the abutment. An abutment screw is used to secure the abutment to the endosseous implant. The CreoDent Solidex® Customized Abutment is compatible with the following: - Astra Tech Osseospeed TX Implants 3.5mm, 4.5mm - Hiossen TS Implants 3.5mm, 4.0mm
    Device Description
    The Solidex® Customized Abutment is Ti-6A1-4V Eli titanium alloy meets ASTM F-136 Standard and Screw is CP TI Gr4 meets ASTM F67 and is designed to be screw retained for use with endosseous dental implants to provide support for a prosthetic restoration. These abutments are indicated for cement or screw retained restorations. Solidex® Customized Abutments are compatible with: - Astra Tech Osseospeed TX Implants 3.5mm, 4.5mm (K024111) - Hiossen TS Implants 3.5mm, 4.0mm (K151858) The design of subject device is customized to the requirements of each patient as may be specified by the prescribing dentist. Customization is limited by the minimum dimensions for wall thickness, diameter, height, collar height and angulation.
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    K Number
    K150012
    Device Name
    CreoDent Solidex Customized Abutment
    Manufacturer
    CREODENT PROSTHETICS, LTD.
    Date Cleared
    2015-06-04

    (150 days)

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

    CREODENT PROSTHETICS, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CreoDent Solidex® Customized Abutment is intended for use with an endosseous implant to support a prosthetic device in patients who are partially or completely endentulous. The device can be used for sinqle or multiple-unit restorations. The prosthesis can be cemented or screw retained to the abutment. An abutment screw is used to secure the abutment to the endosseous implant. The CreoDent Solidex® Customized Abutment is compatible with the following: - . Biomet 3i Osseotite Certain Dental Implants 3.25mm, 4.0mm, 5.0mm, 6.0mm - o Straumann Bone Level Implants 3.3mm. 4.1mm. 4.8mm
    Device Description
    The Solidex® Customized Abutment is Ti-6A1-4V Eli titanium alloy meets ASTM F-136 Standard and Screw is CP TI Gr4 meets ASTM F67 and is designed to be screw retained for use with endosseous dental implants to provide support for a prosthetic restoration. These abutments are indicated for cement or screw retained restorations. Solidex® Customized Abutments are compatibe with: - Biomet 3i Osseotite Certain 3.25mm, 4.0mm, 6.0mm diameter implants K063341 . - Straumann Bone Level implants 3.3mm, 4.1mm, 4.8mm K083550 K121131 . The design of subject device is customized to the requirements of each patient as may be specified by the prescribing dentist. Customization is limited by the minimum dimensions for wall thickness, diameter, height, collar height and angulation.
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