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

    Ora-GUARD Dental Grind Guard

    K Number: K150492 · Decision Feb 19, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    34
    Registration Numbers
    34
    Same Product Code
    44
    Applicant Total
    1
    Review Days
    359

    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
    Ora-GUARD Dental Grind Guard
    K Number
    K150492
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Bite Tech, Inc.
    Date Received
    February 25, 2015
    Decision Date
    February 19, 2016
    Product Code
    OBR
    Advisory Committee
    Unknown
    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
    OBR Mouthguard, Over-The-Counter

    Similar 510(k) Clearances

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

    ClenchNoMore (CNM-1 (Mixed sizing)); ClenchNoMore (CNM-L (Large size)); ClenchNoMore (CNM-S (Small size))

    FDA 510(k)
    FDA Unclassified ·Unknown

    Owl Night Guard

    FDA 510(k)
    FDA Unclassified ·Unknown

    enCore Night Guard

    FDA 510(k)
    FDA Unclassified ·Unknown

    Remi Custom Night Guard

    FDA 510(k)
    FDA Unclassified ·Unknown

    Dentemp Pro-Comfort Dental Guard

    FDA 510(k)
    FDA Unclassified ·Unknown

    Anti Grinding Guard

    FDA 510(k)
    FDA Unclassified ·Unknown
    View all