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

    Blue Sky Bio Aligner

    K Number: K180107 · Decision Feb 9, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    95
    Registration Numbers
    95
    Same Product Code
    143
    Applicant Total
    16
    Review Days
    24

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    Basic Information

    Device Name
    Blue Sky Bio Aligner
    K Number
    K180107
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.5470
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Blue Sky Bio, LLC
    Date Received
    January 16, 2018
    Decision Date
    February 9, 2018
    Product Code
    NXC
    Advisory Committee
    Dental
    Review Advisory Committee
    DE
    Third Party
    Y

    Classifications

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

    Product Code Device Name
    NXC Aligner, Sequential

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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
    K190491 Blue Sky Bio Zygomatic Implant System
    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
    Search all 16 clearances from Blue Sky Bio, LLC →