BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    Blue Sky Bio Zygomatic Implant System

    K Number: K190491 · Decision Aug 12, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    382
    Registration Numbers
    382
    Same Product Code
    708
    Applicant Total
    16
    Review Days
    165

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    Basic Information

    Device Name
    Blue Sky Bio Zygomatic Implant System
    K Number
    K190491
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3630
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Blue Sky Bio, LLC
    Date Received
    February 28, 2019
    Decision Date
    August 12, 2019
    Product Code
    NHA
    Advisory Committee
    Dental
    Review Advisory Committee
    DE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    NHA Abutment, Implant, Dental, Endosseous

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    Other Clearances by Blue Sky Bio, LLC

    K Number Device Name
    K232653 Blue Sky Plan Software, Blue Sky Bio Aligner Z, and Blue Sky Bio Aligner Z FLX
    K221845 Blue Sky Bio Aligner G & Blue Sky Plan S/W for Blue Sky Bio Aligner G
    K212785 Blue Sky Bio Multi One Implant System, Blue Sky Bio Long Implant System, Blue Sky Bio PEEK temporary abutments
    K202026 Blue Sky Bio CAD-CAM Abutments
    K201919 Blue Sky Bio TAD
    K180107 Blue Sky Bio Aligner
    K153064 Blue Sky Bio Zygomatic Implant System
    K112875 BLUE SKY BIO DENTAL TAPER HEX IMPLANT SYSTEMS
    K110198 BLUE SKY BIO TCP
    K102034 BLUE SKY BIO DENTAL IMPLANT SYSTEM
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