BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    BFC3 Powered Impression Gun

    DI: 00723896009246 · Model: 701756 · PRACTICON, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    BFC3 Powered Impression Gun
    Primary DI
    00723896009246
    Version / Model
    701756
    Catalog Number
    70-1756
    Company Name
    PRACTICON, INC.
    Labeler DUNS
    119193803
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-07-20
    Public Version
    3
    Public Version Date
    2021-01-08
    Public Version Status
    Update
    Public Device Record Key
    812368b4-d58a-4a42-b0e4-87822dcf6aea

    Device Description

    Making a great impression is now easier and faster than ever with our BFC3 Powered Impression Gun. BFC3 (Better Faster Comfort, Control, Compatibility) dispenses any type of 1:1 or 2:1 automix material at the press of a button. Fills an entire full-arch tray in less than 10 seconds. No repetitive trigger squeezing to wear out your hand and throw off your aim. Works with standard 25ml, 50ml, and 75ml cartridges. Rechargeable battery dispenses up to sixty 50ml cartridges on a full charge. Convenient, user-friendly, handheld design fits smoothly into normal practice workflow.Familiar, ergonomic design similar to manual automix guns.Fills a full-arch tray in less than 10 seconds. Variable flow speed control, from 0.6 to 1.7ml/sec.Auto-reverse anti-drip control.Auto-stop with overload protection when cartridge is empty.Ideal for filling a batch of original BFC syringes with light-body material.Low battery LED indicator.Wall charger features full-charge indicator LED and overcharge protection circuitry.US Patent Pending. Specifications: Flow range: Adjustable from 0.6 to 1.7ml/sec.Speed: 30.8 seconds to dispense a single full 50ml heavy-body VPS cartridge Capacity: Single 25ml, 50ml, or 75ml 1:1 automix cartridgeBattery: 11.1V lithium-ion Battery life: 60 full 50ml heavy-body VPS cartridges on a full charge Recharge time: 2-1/2 hours Weight: 28.1 oz. (without cartridge)System includes BFC3 impression gun, 50ml plunger (for use with both 25ml and 50ml cartridges), 75ml plunger, wall charger, and countertop stand.Made in USA of US and imported parts. One year warranty.

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    No
    Kit
    No
    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
    No
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    EID Syringe, Restorative And Impression Material

    GMDN Terms

    Code Name
    62681 Dental material cartridge-plunging applicator, two-component, electric

    Identifiers

    Type ID
    Primary 00723896009246