BEUDAMED
    FDA Registration Active 🇺🇸 United States

    3D DIAGNOSTIX INC

    Reg #: 3011429437 · FEI: 3011429437 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    6
    Establishment Types
    3
    Classifications
    4

    Registration Details

    Registration Name
    3D DIAGNOSTIX INC
    Registration Number
    3011429437
    FEI Number
    3011429437
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    24 Denby rd, Suite 148
    City
    Allston
    State
    MA
    ZIP
    02134
    Country
    US

    Regulatory Submissions

    510(k) Number
    K200908

    Owner / Operator

    Firm Name
    3D Diagnostix inc
    Operator Number
    10049937
    Address
    24 Denby Rd, Suite 148
    City
    Allston
    State
    MA
    Postal Code
    02134
    Country
    US

    Products

    Device Name Product Code
    Accessories, Implant, Dental, Endosseous NDP
    Fixture Mount Kit NYE
    Aligner, Sequential NXC
    Mouthguard, Prescription MQC

    Proprietary Names

    3DDX Drills 3DDX Fixation Pins 3DDX Tissue Punch 3DDX Keys 3DDX Surgical Guide Night Guard

    Establishment Types

    Repack or Relabel Medical Device Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device