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510(k) Data Aggregation

    K Number
    K182143
    Device Name
    ALFA GATE Dental Implants System
    Date Cleared
    2019-10-03

    (422 days)

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

    Alfa Gate Mazen Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    ALFA GATE® Dental Implants System is intended for surgical placement in the maxillary and/or mandibular arch to support crowns, bridges, or overdentures in edentulous or partially edentulous patients. ALFA GATE® Dental Implants System may be immediate loading when good primary stability is achieved and with appropriate occlusal loading. ALFA GATE® 3.00mm S-LINE & SLIM implants are intended for placement at the mandibular central and lateral incisors and maxillary lateral incisors. Indicated also for denture stabilization using multiple implants. Two Stage Implants: M+, S-LINE, SCI, SCIP, MAX. One Stage Implants: SLIM Implants. ALFA GATE Dental Implants longer than 13mm are to be used with straight abutments only.
    Device Description
    ALFA GATE® Dental Implant System is consist of endosseous form Dental Implants, Internal hex Implants, Internal Conical Connection Implants, One piece Implants, tapered design; cover screws, healing caps and abutment systems; Dental Implants are provided in two options of surface treatment (1) Bioactive Surface-CaP which is a calcium phosphate coating; or (2) Sand blast large particles with acid etched; Dental Implants: M+ IMPLANTS - Internal Hex, Conical Connection Implant Measurements: Diameter mm 3.5, 4.3, 5.0, 6.0; with Length mm 8, 10, 11.5, 13, 16(not for 60 mm); S-LINE Implants - Internal Hex implant, Narrow Implants BIOACTIVE S-LINE Implant - Measurements: Diameter mm 3.0 with Length mm 10, 11.5, 13; POROUS S-LINE Implant - Measurements: Diameter mm 3.0 with Length mm 10, 11.5, 13: SCI Implants - Internal Hex implant, Spiral conical design BIOACTIVE SCI Implant - Measurements: Diameter mm 3.3, 3.75, 4.2, 4.7, 5.2, 6.0 with Length mm 8, 10, 11.5, 13, 16 (not for 5.20,60 mm); POROUS SCIP Implant - Measurements: Diameter mm 3.3, 3.75, 4.2, 4.7, 5.2, 6.0 with Length mm 8, 10, 11.5, 13, 16 (not for 5.2Ø,6Ø mm): MAX Implant - Internal hex implant, cylindrical and conical body design Measurements: Diameter mm 3.3, 3.75, 4.2, 4.7, 5.2 with Length mm 8, 10, 11.5, 13, 16; SLIM Implant - One Piece implants Measurements: Diameter mm 3.0, 3.3, 3.75 with Length mm 10, 11.5, 13, 15; Dental Abutments: Straight abutments (Regular, Thin, Wide, Narrow), Angled Abutments 15° (Regular, Short), Multi Unit, Shoulder abutments, Esthetic Abutments, Concave Esthetic Abutments, Esthetic Abutments 15°, Concave Angulated Abutments 15°, Esthetic Abutments , Alfa lock abutment (locator), Ball attachment Abutment, Ball attachment concave, Healing Caps (Narrow, Regular, Wide, Slim), Concave healing caps, Anatomic Abutment. Angled abutments are only to be used with S-Line, SCI, and MAX implants. M+ and SLIM implants are not to be used with angled abutments. Dental Abutments Conical Connection: Anatomic straight Abutment (RP, NP), Standard straight abutment (RP, NP), Ball attachment (RP, NP), Healing Caps (RP, NP).
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