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

    The Slide

    K Number: K203712 · Decision Jul 20, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    31
    Registration Numbers
    31
    Same Product Code
    26
    Applicant Total
    10
    Review Days
    211

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    The Slide
    K Number
    K203712
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.5570
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Biotex, Inc.
    Date Received
    December 21, 2020
    Decision Date
    July 20, 2021
    Product Code
    LQZ
    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
    LQZ Device, Jaw Repositioning

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (LQZ), ordered by most recent decision date.

    AIO Breathe

    FDA 510(k)
    FDA Class 2 ·Dental

    RADx Intraoral Appliance for Snoring and Sleep Apnea

    FDA 510(k)
    FDA Class 2 ·Dental

    Slow Wave DS8

    FDA 510(k)
    FDA Class 2 ·Dental

    The NightBlocks Appliance

    FDA 510(k)
    FDA Class 2 ·Dental

    SML-OSA2 Appliances

    FDA 510(k)
    FDA Class 2 ·Dental

    ATG/SM-OSA APPLIANCES

    FDA 510(k)
    FDA Class 2 ·Dental
    View all

    Other Clearances by Biotex, Inc.

    K Number Device Name
    K233442 troCarWash™ System
    K222695 troCarWash™ System
    K161704 Phasor Drill
    K092197 PHOTEX30 DIODE LASER SERIES: 980, 810, 940
    K081656 VISUALASE THERMAL THERAPY SYSTEM
    K071328 VISUALASE THERMAL THERAPY SYSTEM
    K063505 VISUALASE ENVISION SOFTWARE SYSTEM
    K060304 PHOTEX DIODE LASER SERIES, MODELS 980, 810 AND 940
    K053087 VISUALASE COOLED LASER APPLICATOR SYSTEM, LASER DIFFUSING FIBER, COOLING CATHETER SYSTEM