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510(k) Data Aggregation

    K Number
    K010073
    Device Name
    SPLINE DENTAL IMPLANT SYSTEM
    Manufacturer
    SULZER CALCITEK, INC.
    Date Cleared
    2001-01-19

    (10 days)

    Product Code
    DZE
    Regulation Number
    872.3640
    Why did this record match?
    Applicant Name (Manufacturer) :

    SULZER CALCITEK, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K001786
    Device Name
    TEMPORARY GINGIVAL CUFF AND IMPRESSION POST AND IMPLANT ANALOG
    Manufacturer
    SULZER CALCITEK, INC.
    Date Cleared
    2000-06-21

    (8 days)

    Product Code
    DZE
    Regulation Number
    872.3640
    Why did this record match?
    Applicant Name (Manufacturer) :

    SULZER CALCITEK, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K984536
    Device Name
    REMOVABLE CUFF ABUTMENT
    Manufacturer
    SULZER CALCITEK, INC.
    Date Cleared
    1999-06-16

    (177 days)

    Product Code
    DZE
    Regulation Number
    872.3640
    Why did this record match?
    Applicant Name (Manufacturer) :

    SULZER CALCITEK, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Removable Cuff Abutments are screw retained endosseous dental implant abutments and are intended to function as an anchor to which prosthetic devices may be attached using either dental oement or a lingual screw. They are indicated for use on endosseous implants placed in the mandible or maxilla for support of fixed bridgework, removable bridgework or free standing single tooth replacements.
    Device Description
    A Removable Cuff Abutment is a two piece titanium alloy abutment with a separate titanium alloy retaining screw. Each Removable Cuff Abutment is composed of one abutment core body and one removable cuff. Removable Cuff Abutments will be offered as fixed abutments and as pre-angled (15 and 25 degree) abutments for use with both cement and screw retained prosthetics. Abutments will be available in three different diameters at the abutment/implant interface: 3.25mm, 4.0mm and 5.0mm. Flare diameters of cuffs will range from 4.0 to 6.5mm and cuff heights will range from 0.5 mm. A new feature is the addition of a transverse (lingual) screw to some designs. This feature will permit attachment of screw retained prostheses in addition to cement retained prostheses. Removable Cuff Abutments will be packaged with or without the transverse (lingual) screw components.
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    K Number
    K982305
    Device Name
    SPLINE DENTAL IMPLANT SYSTEM-TEMPORARY ABUTMENT
    Manufacturer
    SULZER CALCITEK, INC.
    Date Cleared
    1998-09-22

    (83 days)

    Product Code
    DZE
    Regulation Number
    872.3640
    Why did this record match?
    Applicant Name (Manufacturer) :

    SULZER CALCITEK, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A Temporary Abutment is indicated for use for a maximum of six weeks as an abutment for cemented provisional prostheses. This abutment can be used for single tooth provisional restorations or splinted to other abutments for multi-unit provisional restorations. Single use.
    Device Description
    The Spline Dental Implant System - Temporary Abutment will consist of a titanium alloy abutment cylinder with a separate titanium alloy retaining screw. A Temporary Abutment will attach.directly to the Spline implant with the retaining screw but does not engage the tines. It will be available in three different cuff diameters at the abutment/implant interface: 3.25mm, 4.0mm and 5.0mm. Abutments will also be available with straight wall or stepped cuffs with either a straight or a tapered retentive wall.
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    K Number
    K981562
    Device Name
    SPLINE DENTAL IMPLANT SYSTEM - SPLINE XI IMPLANT
    Manufacturer
    SULZER CALCITEK, INC.
    Date Cleared
    1998-07-30

    (90 days)

    Product Code
    EBF
    Regulation Number
    872.3690
    Why did this record match?
    Applicant Name (Manufacturer) :

    SULZER CALCITEK, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Sulzer Calcitek Dental Implant Systems are designed for use in edentulous mandibles or maxillae for attachment of complete denture prostheses, or as a terminal or intermediary abutment for fixed or removable bridgework, or as a free standing single tooth replacement. The use of the 5.0mm implant is recommended when the quantity and density of bone would dictate the use of an implant larger than 4.0mm.
    Device Description
    Spline XI implants are available both with and without HA-coating. They are available in 3.75mm or 5.0mm diameters and are available in five lengths: 8, 10, 13, 15 and 18mm. A total of four surface styles are available: HA-coated, HAcoated/textured, HA-coated/machined and textured/machined. The implants are supplied sterile.
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    K Number
    K973521
    Device Name
    VARIABLE PARALLEL PIN
    Manufacturer
    SULZER CALCITEK, INC.
    Date Cleared
    1997-11-20

    (64 days)

    Product Code
    DZE, SEP
    Regulation Number
    872.3640
    Why did this record match?
    Applicant Name (Manufacturer) :

    SULZER CALCITEK, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Variable Parallel Pin is intended to provide a visual reference for evaluating parallelism, prosthetic fit and implant spacing between implants and natural teeth during implant placement surgery. The Variable Parallel Pin is indicated for use in evaluating parallelism and fit of the many implant maning and fit of prosthetics with up to 25 degrees and to gadge implaire opensy lants and adjacent natural teeth.
    Device Description
    The Variable Parallel Pin consists of two pivoting pegs that lock in orientations from straight (0) to 25°. The Variable Parallel Pin has cuff width geometry's that match the flare diameters of prosthetic abutments.
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    K Number
    K970127
    Device Name
    EDOSSEOUS DENTAL IMPLANT
    Manufacturer
    SULZER CALCITEK, INC.
    Date Cleared
    1997-06-23

    (160 days)

    Product Code
    DZE
    Regulation Number
    872.3640
    Why did this record match?
    Applicant Name (Manufacturer) :

    SULZER CALCITEK, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Calcitek Dental Implant Systems are designed for use in edentulous mandibles or maxillae for attachment of complete denture prostheses, or as a terminal or intermediary abutment for fixed or removable bridgework, or as a free standing single tooth replacement. The use of the 5.0mm implant is recommended when the quantity and density of bone would dictate the use of an implant larger than 4.0mm.
    Device Description
    These Class III dental implants are supplied sterile, ready for placement by a licensed dontist.
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    K Number
    K970752
    Device Name
    SPLINE ENGAGING SHOULDERED ABUTMENT SYSTEM
    Manufacturer
    SULZER CALCITEK, INC.
    Date Cleared
    1997-06-23

    (112 days)

    Product Code
    DZE
    Regulation Number
    872.3640
    Why did this record match?
    Applicant Name (Manufacturer) :

    SULZER CALCITEK, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For use when screw retention of a single or splinted prosthesis is desired, e.g., single crown, bars and bridges. Implants must be within 30° of parallelism to each other for a splinted prosthesis.
    Device Description
    The Spline Engaging Shouldered Abutment System provides an antirotational option for single or multiple tooth prosthetic restorations. The components of this system are supplied non-sterile, for use by licensed dentists.
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    K Number
    K964768
    Device Name
    THREADLOC DENTAL IMPLANT SYSTEMS
    Manufacturer
    SULZER CALCITEK, INC.
    Date Cleared
    1997-02-25

    (90 days)

    Product Code
    DZE
    Regulation Number
    872.3640
    Why did this record match?
    Applicant Name (Manufacturer) :

    SULZER CALCITEK, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For use in edentulous mandibles or maxillae for attachment of complete denture prostheses, or as a terminal or intermediary abutment for fixed or removable bridgework, or as a free standing single tooth replacement.
    Device Description
    These Class III dental implants are supplied sterile, ready for placement by a licensed dentist. There has been no significant change to the prosthetic components.
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    K Number
    K962576
    Device Name
    SPLINE X ENDOSSEOUS DENTAL IMPLANT SYSTEM
    Manufacturer
    CALCITEK, INC.
    Date Cleared
    1997-02-10

    (224 days)

    Product Code
    DZE
    Regulation Number
    872.3640
    Why did this record match?
    Applicant Name (Manufacturer) :

    CALCITEK, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For use in edentulous mandibles or maxillae for attachment of complete denture prostheses, or as a terminal or intermediary abutment for fixed or removable bridgework, or as a free standing single tooth replacement.
    Device Description
    These Class III dental implants are supplied sterile, ready for placement by a licensed dentist. There has been no significant change to the prosthetic components.
    Ask a Question

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