BEUDAMED
    FDA Registration Active 🇧🇷 Brazil

    DENTSCARE LTDA

    Reg #: 3007210751 · FEI: 3007210751 · Expires 2026
    View on FDA
    Products
    14
    Proprietary Names
    45
    Establishment Types
    2
    Classifications
    14

    Registration Details

    Registration Name
    DENTSCARE LTDA
    Registration Number
    3007210751
    FEI Number
    3007210751
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Av. Edgar Nelson Meister, 474
    City
    Joinville Santa Catarina
    Country
    BR

    Regulatory Submissions

    510(k) Number
    K231859

    Owner / Operator

    Firm Name
    Dentscare Ltda
    Operator Number
    10055009
    Address
    Av. Edgar Nelson Meister, 474
    City
    Joinville
    State
    Santa Catarina
    Postal Code
    89219-501
    Country
    BR
    Correspondent
    Friedrich G Mittelstadt

    US Agent

    Business Name
    United Regulatory & Logistics LLC
    Contact Name
    Rodrigo Abreu
    Address
    2950 W Cypress Creek Rdd #110
    City
    Fort Lauderdale
    State
    FL
    ZIP
    33309
    Country
    US
    Email
    [email protected]
    Phone
    786 2667900

    Products

    Device Name Product Code
    Crown And Bridge, Long-Term Temporary, Resin POW
    Crown And Bridge, Temporary, Resin EBG
    Agent, Polishing, Abrasive, Oral Cavity EJR
    Agent, Tooth Bonding, Resin KLE
    Sealant, Pit And Fissure, And Conditioner EBC
    Material, Tooth Shade, Resin EBF
    Cement, Dental EMA
    Drill, Dental, Intraoral DZA
    Dam, Rubber EIE
    Adhesive, Bracket And Tooth Conditioner, Resin DYH
    Retractor, All Types EIG
    Post, Root Canal ELR
    Applicator, Resin KXR
    Wheel, Polishing Agent EJQ

    Proprietary Names

    3007210751 Diamond R Diamond Master Diamond Excel Diamond ACI & ACII Diamond Excel Ultrafine Ambar APS Ambar Universal APS 10055009 Opus Bulk Fill Flow APS Opus Bulk Fill APS Allcem Core Allcem Whitepost DC Drill Whitepost DC-E Drill Whitepost System DC Drill Whitepost System DC-E Drill Whitepost System DC Fit TOP DAM 1G TOP DAM 2G Orthocem Ortho Bite Arcflex Whitepost DC-E Whitepost DC Whitepost System DC FIT Intro Whitepost System DC Intro Whitepost System DC FIT Refill Whitepost System DC-E Kit Whitepost System DC Kit Whitepost System DC-E Refill Whitepost System DC Refill Whitepost System DC-E Intro Whitepost System DC-E Refill Mix Whitepost System DC Refill Mix Whitepost System DC FIT Refill Mix Allcem Core Mixing tips Allcem Veneer APS Allcem Veneer Try-in Vittra APS Unique Diamond Pro Diamond Flex Diamond Llis Vittra APS

    Establishment Types

    Manufacture Medical Device Repack or Relabel Medical Device