BEUDAMED
    FDA Registration Active 🇸🇪 Sweden

    NEOSS AB

    Reg #: 3017399129 · FEI: 3017399129 · Expires 2026
    View on FDA
    Products
    13
    Proprietary Names
    15
    Establishment Types
    2
    Classifications
    13

    Registration Details

    Registration Name
    NEOSS AB
    Registration Number
    3017399129
    FEI Number
    3017399129
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Arvid Wallgrens Backe 20
    City
    Goteborg Vastra Gotaland
    Country
    SE

    Regulatory Submissions

    510(k) Number
    K100156

    Owner / Operator

    Firm Name
    Neoss AB
    Operator Number
    10077271
    Address
    Arvid Wallgrens Backe 20
    City
    Goteborg
    State
    Vastra Gotaland
    Postal Code
    41346
    Country
    SE
    Correspondent
    Maria Lopez

    US Agent

    Business Name
    Pro Pharma Group
    Contact Name
    Cherita James
    Address
    1129 20th St Nw Ste 600
    City
    Washington
    State
    DC
    ZIP
    20036
    Country
    US
    Email
    [email protected]
    Phone
    347 9540624

    Products

    Device Name Product Code
    Handle, Instrument, Dental EJB
    Barrier, Animal Source, Intraoral NPL
    Abutment, Implant, Dental, Endosseous NHA
    Implant, Endosseous, Root-Form DZE
    Handpiece, Direct Drive, Ac-Powered EKX
    Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene NBY
    Bone Grafting Material, Animal Source NPM
    Accessories, Implant, Dental, Endosseous NDP
    Barrier, Synthetic, Intraoral NPK
    System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations NOF
    Wound Dressing With Animal-Derived Material(S) KGN
    Attachment, Precision, All EGG
    Screw, Fixation, Intraosseous DZL

    Proprietary Names

    Adjustment handle NeoGen Collagen Firm Neoss PTFE Suture NeoGen Collagen Flex Yomi One Drills, Yomi One Countersinks, Yomi One Instruments and accessories Neoss Instruments and Accessories, Implant Inserter, Screwdriver, Impression Coping, Replica, Scan Body, ScanPeg, Ratchet, Wrench adapter, Neoss Guide, Tack and Screw Cassette, Tack Insertion Pin, Twist Drill, Countersink, Round bur, Lance Drill, Pilot Drill Intra-Oral Scanner, NeoScan Clix Activating Tool, Clix Gold Housiing, Cix Insertion Tool, Clix Insert Kit, Clix Ti Housing Kit, Clix Deactivating T, Neoss Implant System Ball Abutment 1-3-4.5-6mm, LOCATOR-male process package assembly, Locator replacement male green LOCATOR replacement - male Red, male clear, male extralight retention blue, male light retention pink Equator Neoss Individual Prosthetics 1- 6mm Locator Abutment for Neoss 4.1mmD Implant

    Establishment Types

    Manufacture Medical Device Export Device to the United States But Perform No Other Operation on Device