BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Dental LT Comfort Resin

    Reg #: 3010279788 · FEI: 3010279788 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    Formlabs Inc.
    Registration Number
    3010279788
    FEI Number
    3010279788
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    35 Medford St
    City
    Somerville
    State
    MA
    ZIP
    02143
    Country
    US

    Regulatory Submissions

    510(k) Number
    K232087

    Owner / Operator

    Firm Name
    Formlabs Inc.
    Operator Number
    10060005
    Address
    35 Medford St
    City
    Somerville
    State
    MA
    Postal Code
    02143
    Country
    US

    Products

    Device Name Product Code
    Positioner, Tooth, Preformed KMY
    Mouthguard, Prescription MQC

    Proprietary Names

    Dental LT Comfort Resin

    Establishment Types

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