BEUDAMED
    FDA Registration Active 🇺🇸 United States

    PREMIERE 1 DENTAL LABORATORY, L.L.C.

    Reg #: 3006459726 · FEI: 3006459726 · Expires 2026
    View on FDA
    Products
    9
    Proprietary Names
    9
    Establishment Types
    1
    Classifications
    9

    Registration Details

    Registration Name
    PREMIERE 1 DENTAL LABORATORY, L.L.C.
    Registration Number
    3006459726
    FEI Number
    3006459726
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    302 Manatee Avenue East, Suite 201
    City
    Bradenton
    State
    FL
    ZIP
    34208
    Country
    US

    Regulatory Submissions

    510(k) Number
    K060507

    Owner / Operator

    Firm Name
    PREMIERE 1 DENTAL LABORATORY, L.L.C.
    Operator Number
    9106559
    Address
    302 Manatee Avenue East, Suite 201
    City
    Bradenton
    State
    FL
    Postal Code
    34208
    Country
    US
    Correspondent
    Domingo Hernandez

    Products

    Device Name Product Code
    Denture, Plastic, Teeth ELM
    Denture Preformed (Partially Prefabricated Denture) EKO
    Crown And Bridge, Temporary, Resin EBG
    Restoration, Noble Metal NSJ
    Dentures, Full NSL
    Alloy, Gold-Based Noble Metal EJT
    Restoration, Porcelain-Fused-To-Metal NSO
    Restoration, Porcelain NSP
    Restoration, Base Metal NSQ

    Proprietary Names

    Denture, Partial, Acrylic Teeth, Plastic, Plastic Teeth Preformed Denture Teeth, Partially Fabricated Denture, Partially Fabricated Partial Denture, Crown, Bridge, Temporary Resin, Porcelain Crown Alloy, Noble Metal, Metal Crown Denture, Acrylic Teeth, Denture, Partial Denture Alloy, Gold, Base Metal Porcelain Fused to Metal, Crown, Restoration, Metal Crown Porcelain Restoration, Porcelain Crown, Porcelain Fused to Metal Base Metal, Metal Crown, Preformed Crown,

    Establishment Types

    Repack or Relabel Medical Device