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510(k) Data Aggregation

    K Number
    K211409
    Device Name
    Proximerge 2 Dental Implant System
    Manufacturer
    Quadric BioMed, LLC
    Date Cleared
    2022-10-19

    (531 days)

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

    Quadric BioMed, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Proximerge™ 2 Dental Implant System is designed for use in edentulous sites in the mandible or maxilla as a single tooth replacement. These implants are indicated for delayed loading.
    Device Description
    The Proximerge 2TM Dental Implant System is an integrated system of endosseous dental implants with corresponding abutments, temporary abutments, and closure screws. The implants are designed with elongation in the mesial-distal dimension. The implants have a 7mm length and a mesial-distal elongated footprint in 4.5x6.3mm, 4.5x7.6mm, 4.5x9.1mm, and 4.5x10.5mm options and are press-fit into the bone. The abutments have a 0° angulation, have post and gingival heights of 4.5mm and 2.4mm respectively for each implant size, and have a tapered implant-abutment interface . Temporary tissue former abutments (also called healing abutments) and healing caps are offered to protect the implant until the abutment is attached; the tissue formers and healing caps have the same angulation and implant-abutment interface as the permanent abutments. An M1.8 capture screw attaches the abutment, the tissue forming abutment, or the healing cap to the implant. All components in the Proximerge™ 2 Dental Implant System are manufactured from Ti-6A1-4V ELI per ASTM F136.
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    K Number
    K041268
    Device Name
    SILVERSITE OR CALGITROL
    Manufacturer
    ADRI
    Date Cleared
    2004-09-20

    (131 days)

    Product Code
    MGQ, FRO
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    ADRI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Professional Indications (Prescription Use): Pressure ulcers, Stages I-IV Dermal lesions (or secreting skin injuries) Venous ulcers, Stasis ulcers Intended to protect vascular access sites, intramuscular sites, and surgical incisions 1" and 20d degree burns Donor sites
    Device Description
    The device is a silver ion-containing dressing in which the silver ion is in the form of a molecule of silver alginate. The silver alginate is interspersed in a matrix of calcium alginate and therefore all of the silver in the device is in the ionic state. The silver alginate in its composition prior to layering on a suitable backing is stirred in order to introduce a foam into the silver alginate composition, which foam will materially assist in absorbing exudates from an exudating wound. The foam composition of the silver alginate gel as composed above has the advantage of absorbing a considerable amount of exudates where such wounds may be treated with this dressing. The layering of the composition as described above is performed on a polyester or polyurethane backing which absorbs excess exudate.
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    K Number
    K011618
    Device Name
    CALGITROL AG SILVER ALGINATE WOUND DRESSING
    Manufacturer
    ADRI
    Date Cleared
    2002-11-15

    (539 days)

    Product Code
    FRO
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    ADRI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Pressure ulcers, Stages I-IV Dermal lesions (or secreting skin injuries) Venous ulcers, Stasis ulcers 1st and 2nd degree burns; donor sites
    Device Description
    CALGITROL™ Ag Silver Alginate Foam and Gel Foam Dressings with or without Maltodextrin
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    K Number
    K003134
    Device Name
    FOAM CALCIUM ALGINATE TOPICAL WOUND DRESSING
    Manufacturer
    ADRI/TECHNAM
    Date Cleared
    2000-12-22

    (77 days)

    Product Code
    KGN
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    ADRI/TECHNAM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K000054
    Device Name
    FOAM CALCIUM ALGINATE TOPICAL WOUND DRESSING WITH COLLAGEN
    Manufacturer
    ADRI
    Date Cleared
    2000-03-13

    (66 days)

    Product Code
    KGN
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    ADRI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K963656
    Device Name
    FOAM CALCIUM ALIGINATE TOPICAL WOUND DRESSING
    Manufacturer
    ADRI
    Date Cleared
    1996-11-12

    (61 days)

    Product Code
    KMF
    Regulation Number
    880.5090
    Why did this record match?
    Applicant Name (Manufacturer) :

    ADRI

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