BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Formlabs Ohio, Inc.

    Reg #: 3015491441 · FEI: 3015491441 · Expires 2026
    View on FDA
    Products
    8
    Proprietary Names
    8
    Establishment Types
    2
    Classifications
    8

    Registration Details

    Registration Name
    Formlabs Ohio, Inc.
    Registration Number
    3015491441
    FEI Number
    3015491441
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    27800 Lemoyne Rd
    City
    Millbury
    State
    OH
    ZIP
    43447
    Country
    US

    Regulatory Submissions

    510(k) Number
    K240538

    Owner / Operator

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

    Products

    Device Name Product Code
    Spoon, Ophthalmic HNB
    Material, Impression Tray, Resin EBH
    Accessories, Implant, Dental, Endosseous NDP
    Crown And Bridge, Temporary, Resin EBG
    Additively Manufactured, Preformed, Resin Denture Tooth PZY
    Positioner, Tooth, Preformed KMY
    Mouthguard, Prescription MQC
    Maintainer, Space Preformed, Orthodontic DYT

    Proprietary Names

    Custom Tray Resin IBT Resin IBT Flex Resin H-0600 Resin Surgical Guide Resin Premium Teeth Resin Dental LT Comfort Resin Dental LT Clear V2 Resin

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198