BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    Pad Lock

    DI: D798PLTK0 · Model: PLTK · RELIANCE ORTHODONTIC PRODUCTS INC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    Pad Lock
    Primary DI
    D798PLTK0
    Version / Model
    PLTK
    Catalog Number
    PLTK
    Company Name
    RELIANCE ORTHODONTIC PRODUCTS INC
    Labeler DUNS
    113170088
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-08-10
    Public Version
    2
    Public Version Date
    2018-03-29
    Public Version Status
    Update
    Public Device Record Key
    123e870e-c52d-4ff7-8f51-02cd62fda4aa
    Distribution End Date
    2017-12-21

    Device Description

    Pad Lock® is intended for use as a fluorescing, light cure orthodontic bracket adhesive. Pad Lock® paste will fluoresce when illuminated with a black light to reveal flash upon bracket placement. In addition, the cured paste under the bracket base will fluoresce at the time of debonding making it easier to see and remove the adhesive Kit contains 18g Padlock adhesive paste in tips, 2 x 3cc Light Bond Sealant Resins, 9 gm liquid etchant, mixing pad, spatulas and brush applicators. This kit is Non-Fluoride.

    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 D798PLTK0

    Customer Contacts

    Phone
    6307734009
    Email
    [email protected]

    Storage Conditions

    Type
    Special Storage Condition, Specify
    Special Conditions
    Store refrigerated (2-8 degrees C). Avoid excessive heat. Allow product to reach room temper ature prior to use.