BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    HT4004 40/04 taper Plugger

    Reg #: 3005831677 · FEI: 3005831677 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    46
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    B&L BIOTECH CO., INC
    Registration Number
    3005831677
    FEI Number
    3005831677
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    #502, Gungjeon Tower, 723-3, Gojan-dong, Danwon-gu
    City
    Ansan City Gyeonggi
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K060347

    Owner / Operator

    Firm Name
    B&L BIOTECH CO., LTD.
    Operator Number
    9082994
    Address
    #502 GUNGJEON TOWER, 723-3 GOJAN-DONG, DANWON-GU
    City
    ANSAN-CITY, KYUNGK-DO
    State
    KR-NOTA
    Postal Code
    15462
    Country
    KR

    US Agent

    Business Name
    Kamm & Associates
    Contact Name
    Daniel Kamm
    Address
    8870 Ravello Ct
    City
    Naples
    State
    FL
    ZIP
    34114
    Country
    US
    Email
    [email protected]
    Phone
    239 4171727

    Products

    Device Name Product Code
    Plugger, Root Canal, Endodontic EKR

    Proprietary Names

    HT4004 40/04 taper Plugger Hotshot BP-B1 WL-B1 B&L-Beta BP-B1 Beta Mini CL-A1 B&L-Alpha II AP-A1 Alpha Plus Obtura Spartan 45/4 taper Plugger Obtura Spartan 55/.10 taper Plugger Obtura Spartan 55/6 taper Plugger Obtura Spartan 35/4 taper Plugger Obtura MaxPack System Alpha II Plugger BP4504 Alpha II Plugger BP5508 Obtura Spartan 60/.12 taper Plugger Obtura Spartan 40/4 taper Plugger Alpha II Plugger BP6012 Obtura Spartan 55/8 taper Plugger Alpha Enclosure Thermal Protector Caps Alpha Alpha II Plugger BP4004 Alpha II Plugger BP3504 Alpha II Plugger BP5508L Alpha II Plugger BP5004 Alpha II Plugger BP5506 Alpha II Plugger BP5510 Silicone Cover AC adaptor protector cap BPAN Alpha II CL-A1 Alpha II WL-B1 B&L Beta Micro plugger JP6JP7 HT3504 35/04 taper Plugger Hottip Alpha II CL-A1 Ball Burnisher & Micro plugger JB2JP3 Hottip CL-A1 HT5506 55/06 taper plugger Hotshot BP-B1 Beta Mini HT4504 45/04 taper Plugger HT5508L 55/08 taper plugger long type HT3004 30/04 taper Plugger HT6012 60/12 taper pluger HT5510 55/10 taper plugger HT5508 55/08 taper plugger HT5004 50/04 taper Plugger

    Establishment Types

    Manufacture Medical Device