BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Solea

    Reg #: 3010175098 · FEI: 3010175098 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    8
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    CONVERGENT DENTAL
    Registration Number
    3010175098
    FEI Number
    3010175098
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    100 Fifth Avenue, Suite 1010
    City
    Waltham
    State
    MA
    ZIP
    02451
    Country
    US

    Regulatory Submissions

    510(k) Number
    K151306

    Owner / Operator

    Firm Name
    Convergent Dental
    Operator Number
    10043517
    Address
    100 Fifth Avenue, Suite 1010
    City
    Waltham
    State
    MA
    Postal Code
    02451
    Country
    US
    Correspondent
    Joe Coscia

    Products

    Device Name Product Code
    Ventilatory Effort Recorder MNR
    Powered Laser Surgical Instrument GEX

    Proprietary Names

    Solea WatchPAT ONE Watch-PAT1 WP1 Watch-PAT ONE WatchPAT-ONE WatchPAT ONE-M Probes WatchPAT™ONE

    Establishment Types

    Manufacture Medical Device