BEUDAMED
    FDA Registration Active 🇮🇳 India

    Rootfyx (Bio Ceramic Sealer - single paste)

    Reg #: 3008822460 · FEI: 3008822460 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    8
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Shiva Products
    Registration Number
    3008822460
    FEI Number
    3008822460
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    B/18, Dwarka indl. Estate, Naik Pada,, Waliv, Vasai (East)
    City
    Dist. Palghar Maharashtra
    Country
    IN

    Regulatory Submissions

    510(k) Number
    K240446

    Owner / Operator

    Firm Name
    Shiva Products
    Operator Number
    10047303
    Address
    214, Blue Bell Industrial Estate, Chinch Pada
    City
    Mumbai
    State
    Maharashtra
    Postal Code
    401208
    Country
    IN
    Correspondent
    Ranjan H Doshi

    US Agent

    Business Name
    Pearson Dental Supplies
    Contact Name
    Perry Kashfian
    Address
    13161 Telfair Avenue, Sylmar, CA
    City
    Kagel Canyon
    State
    CA
    ZIP
    91342
    Country
    US
    Email
    [email protected]
    Phone
    818 3622600 ext. 359

    Products

    Device Name Product Code
    Resin, Root Canal Filling KIF

    Proprietary Names

    Rootfyx (Bio Ceramic Sealer - single paste) Sealmax + [Root Canal Sealer (Ca based)] MTA Calcium Hydroxide Powder with barium sulphate Ceraseal-B (Bio Ceramic Sealer) Sealmax - R (Resin Based Root Canal Sealer) Calx - O (radio Opaque Water based Calcium Hydroxide with barium Sulphate) Calahyd - Rc (Calcium Hydroxide With Iodoform)

    Establishment Types

    Manufacture Medical Device