BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    Restorative System

    DI: D785RESTORATIVEKIT0 · Model: Restorative Instrumentation System · OCO BIOMEDICAL INC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    Restorative System
    Primary DI
    D785RESTORATIVEKIT0
    Version / Model
    Restorative Instrumentation System
    Catalog Number
    Restorative Kit
    Company Name
    OCO BIOMEDICAL INC
    Labeler DUNS
    094146123
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-04-21
    Public Version
    3
    Public Version Date
    2024-02-13
    Public Version Status
    Update
    Public Device Record Key
    52702d99-704f-471c-a6ae-d1a9cb0b7b8a
    Distribution End Date
    2021-10-28

    Device Description

    Restorative Instrumentation System Everything you need to restore our entire line of two-stage implants A system that contains all instrumentation needed to restore our entire line of two stage dental implants; including the TSI, ERI, Engage™ and Macro™. All components are labeled for easy removal and return to the tray after autoclaving for sterilization.

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    Yes
    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
    Yes
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    Yes
    Sterilization Methods
    Moist Heat or Steam Sterilization

    Product Codes

    Code Name
    EIL Gauge, Depth, Instrument, Dental

    GMDN Terms

    Code Name
    45147 Dental/maxillofacial surgical procedure kit, non-medicated, reusable

    Identifiers

    Type ID
    Primary D785RESTORATIVEKIT0