BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    MR Lock LC

    DI: 00190746061516 · Model: 001-975 · AMERICAN ORTHODONTICS CORPORATION
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    MR Lock LC
    Primary DI
    00190746061516
    Version / Model
    001-975
    Catalog Number
    001-975
    Company Name
    AMERICAN ORTHODONTICS CORPORATION
    Labeler DUNS
    044668515
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2026-04-10
    Public Version
    1
    Public Version Date
    2026-04-20
    Public Version Status
    New
    Public Device Record Key
    a10ebf3a-b19c-41a8-9fd7-c66a3237c358

    Device Description

    MR LOCK BAND CEMENT 50/PK

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    Yes
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    No
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    DYH ADHESIVE, BRACKET AND TOOTH CONDITIONER, RESIN

    GMDN Terms

    Code Name
    31750 Orthodontic bracket adhesive

    Identifiers

    Type ID
    Primary 00190746061516

    Customer Contacts

    Phone
    +1(800)558-7687
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K001446 000

    Storage Conditions

    Type
    Special Storage Condition, Specify
    Special Conditions
    Keep Away from Light
    Type
    Storage Environment Temperature
    Temperature Range
    2 – 24 Degrees Celsius