BEUDAMED
    FDA Registration Active 🇹🇼 Taiwan

    ROLENCE ENT. INC.

    Reg #: 8044167 · FEI: 3002772487 · Expires 2026
    View on FDA
    Products
    12
    Proprietary Names
    16
    Establishment Types
    2
    Classifications
    12

    Registration Details

    Registration Name
    ROLENCE ENT. INC.
    Registration Number
    8044167
    FEI Number
    3002772487
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    18-3 LANE 231 PU CHUNG RD.
    City
    CHUNGLI Taoyuan
    Country
    TW

    Regulatory Submissions

    510(k) Number
    K043325

    Owner / Operator

    Firm Name
    ROLENCE ENT. INC.
    Operator Number
    9005974
    Address
    18-3 LANE 231 PU CHUNG RD., --
    City
    CHUNGLI
    State
    Taoyuan
    Postal Code
    32083
    Country
    TW
    Correspondent
    STERLING - CHENG

    US Agent

    Business Name
    ROC Chinese-European Industrial Research Society
    Contact Name
    Shu-Chen Cheng
    Address
    2064 Tamarin Dr
    City
    Columbus
    State
    OH
    ZIP
    43235
    Country
    US
    Email
    [email protected]
    Phone
    614 5888168

    Products

    Device Name Product Code
    Unit, Operative Dental EIA
    Heat Source For Bleaching Teeth EEG
    System, X-Ray, Extraoral Source, Digital MUH
    Unit, X-Ray, Extraoral With Timer EHD
    Cup, Prophylaxis EHK
    Bur, Dental EJL
    Activator, Ultraviolet, For Polymerization EBZ
    Unit, Syringe, Air And/Or Water ECB
    Handpiece, Air-Powered, Dental EFB
    Scaler, Ultrasonic ELC
    Mouthpiece, Saliva Ejector DYN
    Warmer, Anesthetic Tube EFC

    Proprietary Names

    zoomcam elitedent crystal ; elitedent Extraoral X-Ray Unit PROPHY ANGLE Dental Burs ultra-lite q-lux 3-way syringes ROLENCE Dental High Speed Handpiece intelligence elegance Intraoral Digital X-Ray Sensor SALIVA EJECTOR Composite / Resin Heater

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device Manufacture Medical Device