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510(k) Data Aggregation

    K Number
    K972769
    Device Name
    OPTI-MAX ANGLED CROWN POST FOR EXTERNALLY-HEXED IMPLANTS, IN 15 DEGREE AND 25 DEGREE INCLINATIONS. FOR IMPLANTS 3.3MM, 4
    Manufacturer
    OPTI-MAX
    Date Cleared
    1997-11-13

    (112 days)

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

    OPTI-MAX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Opti-Max angled crown post for externally-hexed implants is intended to be used as an abutment for a cast crown, to be retained by cementation. The metal for this cast crown is to be composed of a computible formulation when in contact with Ti6A4V. If light retention is desired by the cinician zinc-oxide cement can be used, if stronger retention is desired, carboxylate cements of an be used. The cast crown seated on this crown post may be single and free-sanding, part of fixed bridgework, or connected to a bar structure for overdenture retention.
    Device Description
    Opti-Max Angled Crown Post for Externally-Hexed Implants
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    K Number
    K960022
    Device Name
    OPTI-MAX BODY DIAMETER W/5MM TOP W/EXTERNAL HEX, EXTERNALLY THREADED DENTAL IMPLANT COARSE THREADS
    Manufacturer
    OPTI-MAX
    Date Cleared
    1996-05-24

    (143 days)

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

    OPTI-MAX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K955332
    Device Name
    OPTI-MAX EXTERNALLY THREADED CYLINDRICAL INTERNAL BORE DENTAL IMPLANT, WITH HEALING SCREW
    Manufacturer
    OPTI-MAX
    Date Cleared
    1996-05-06

    (168 days)

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

    OPTI-MAX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

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