BEUDAMED
    FDA Registration Active 🇺🇸 United States

    OXFORD PERFORMANCE MATERIALS, INC.

    Reg #: 3009582362 · FEI: 3009582362 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    13
    Establishment Types
    3
    Classifications
    4

    Registration Details

    Registration Name
    OXFORD PERFORMANCE MATERIALS, INC.
    Registration Number
    3009582362
    FEI Number
    3009582362
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    30 South Satellite Road
    City
    South Windsor
    State
    CT
    ZIP
    06074
    Country
    US

    Regulatory Submissions

    510(k) Number
    K161052

    Owner / Operator

    Firm Name
    Oxford Performance Materials, Inc.
    Operator Number
    10043473
    Address
    30 South Satellite Road
    City
    South Windsor
    State
    CT
    Postal Code
    06074
    Country
    US
    Correspondent
    James Porteus

    Products

    Device Name Product Code
    Prosthesis, Tracheal, Expandable JCT
    Material, Tooth Shade, Resin EBF
    Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction KKY
    Plate, Cranioplasty, Preformed, Non-Alterable GXN

    Proprietary Names

    Pekkton® Ivory Milling blank 98.5/t24mm Pekkton® Ivory Milling blank 95/t25mm Pekkton® Ivory Milling blank 98.5/t28mm Pekkton® Ivory Milling blank 98.5/t16mm Pekkton® Ivory Milling blank 98.5/t12mm Pekkton® Ivory Milling blank 98.5/t20mm Pekkton® Ivory Milling blank 95/t16mm Pekkton® Ivory Milling blank 95/t20mm Pekkton® Ivory Milling blank 95/t12mm Pekkton® Ivory Milling blank 95/t30mm HTR-PEKK OsteoFab Patient Specific Facial Device - Optimized OsteoFab Patient Specific Cranial Device

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device