BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Bonita

    Reg #: 3006367836 · FEI: 3006367836 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    DENALI R & D CORPORATION
    Registration Number
    3006367836
    FEI Number
    3006367836
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    134 Old Washington Street
    City
    Hanover
    State
    MA
    ZIP
    02339
    Country
    US

    Regulatory Submissions

    510(k) Number
    K071158

    Owner / Operator

    Firm Name
    Denali R & D Corporation
    Operator Number
    10027456
    Address
    124 Old Washington Street
    City
    Hanover
    State
    MA
    Postal Code
    02339
    Country
    US
    Correspondent
    Jan G Stannard

    Products

    Device Name Product Code
    Sealant, Pit And Fissure, And Conditioner EBC

    Proprietary Names

    Bonita AURA Lay

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility