BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    DETAX GMBH

    Reg #: 9680954 · FEI: 1000293792 · Expires 2026
    View on FDA
    Products
    16
    Proprietary Names
    90
    Establishment Types
    3
    Classifications
    16

    Registration Details

    Registration Name
    DETAX GMBH
    Registration Number
    9680954
    FEI Number
    1000293792
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    CARL-ZEISS-STR. 4
    City
    ETTLINGEN Baden-Wurttemberg
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K222877

    Owner / Operator

    Firm Name
    DETAX GMBH
    Operator Number
    9012556
    Address
    CARL-ZEISS-STR. 4, --
    City
    ETTLINGEN
    State
    Baden-Wurttemberg
    Postal Code
    76275
    Country
    DE

    US Agent

    Business Name
    Aclivi, LLC
    Contact Name
    Chris Brown
    Address
    405 Tropics Ave
    City
    Daytona Beach
    State
    FL
    ZIP
    32124
    Country
    US
    Email
    [email protected]
    Phone
    810 3609773

    Products

    Device Name Product Code
    Syringe, Restorative And Impression Material EID
    Protector, Hearing (Insert) EWD
    Material, Tooth Shade, Resin EBF
    Crown And Bridge, Temporary, Resin EBG
    Additively Manufactured, Preformed, Resin Denture Tooth PZY
    Hearing Aid, Air-Conduction, Prescription ESD
    Positioner, Tooth, Preformed KMY
    Resin, Denture, Relining, Repairing, Rebasing EBI
    Mouthguard, Prescription MQC
    Material, Impression ELW
    Maintainer, Space Preformed, Orthodontic DYT
    Retainer, Screw Expansion, Orthodontic DYJ
    Material, Impression Tray, Resin EBH
    Syringe, Ent KCP
    Cement, Dental EMA
    Accessories, Implant, Dental, Endosseous NDP

    Proprietary Names

    bioflex 40 rose 4x50ml protect mold neon-orange 2x100ml direct mold rose-transparent 8x50ml protect mold neon-pink 2x100ml bioflex 40 red 4x50ml aquaplus colormix orange 8x50ml bioflex 40 blue 4x50ml aquaplus colormix yellow 8x50 ml aquaplus colormix red 8x50 ml aquaplus colormix green 8x50ml bioflex 40 transparent 4x50 ml aquaplus colormix blue 8x50 ml protect mold neon-green 2x100ml aquaplus colormix red/blue 8x50ml aquaplus colormix standard pack 8x50ml protect mold neon-yellow 2x100ml VITA VIONIC® DENT RESIN B3 1000g VITA VIONIC® DENT RESIN A1 500g VITA VIONIC® DENT RESIN B3 500g VITA VIONIC® DENT RESIN C2 500g VITA VIONIC® DENT RESIN A2 500g VITA VIONIC® DENT RESIN A1 1000g VITA VIONIC® DENT RESIN C2 1000g VITA VIONIC® DENT RESIN 0M3 500g VITA VIONIC® DENT RESIN 0M3 1000g VITA VIONIC® DENT RESIN A2 1000g VITA VIONIC® DENT RESIN A3 1000g VITA VIONIC® DENT RESIN A3 500g VITA VIONIC® DENT RESIN B1 1000g VITA VIONIC® DENT RESIN A3,5 500g FREEPRINT® crown A3,5 1000g VITA VIONIC® DENT RESIN A3,5 1000g VITA VIONIC® DENT RESIN D3 1000g FREEPRINT® crown A3,5 500g VITA VIONIC® DENT RESIN D3 500g VITA VIONIC® DeNT RESIN B1 500g FREEPRINT crown A3,5 1000g FREEPRINT crown A3,5 500g VITA VIONIC® DENT RESIN B1 500g earflex rose 60 shore 8 x 50 ml detax softwear 2 pink-fluorescent 60 shore 2x50ml detax softwear 2 yellow fluorescent 40 shore 2x50ml addition Junior/DIC 4 x 50 ml medicalprint nobreak red-transparent 1000g medicalprint nobreak green-opaque 1000g medicalprint nobreak orange transparent 1000g addition ultra Automix 2 addition supra Automix 2 8x50ml detax softwear 2 rose 40 8x50 ml luxaprint shell white bioplast 25 shore 8 x 50ml medicalprint shell beige 2 1000g medicalprint nobreak purple 1000g Medicalprint nobreak blue-transparent 1000g Medicalprint nobreak white 1000g medicalprint coat medicalprint nobreak dark grey 1000g medicalprint nobreak brown 1000g medicalprint nobreak neon yellow 1000g VITA VIONIC® TRY-IN RESIN A2 500g VITA VIONIC® TRY-IN RESIN 1000g tempofit premium B1 tempofit premium BL freeprint denture flex pink 1000g RS VIVO Denture Flex pink transparent 1000g freeprint denture flex pink transparent 1000g VITA VIONIC® BASE RESIN FLEX pink transparent 1000g VITA VIONIC® BASE RESIN FLEX clear 1000g RS VIVO Denture Flex transparent 1000g Primeprint Splint ST 1000g FREEPRINT splintmaster taff 1000g RS VIVO Splint Flex 1000g Primeprint Splint SF 1000g FREEPRINT splintmaster flex 1000g RS VIVO Splint Hard 1000g Primeprint Splint SF dx retainer 1000g dx retainer 5kg RS VIVO IBT 1000g mixing cannulas optima lilac 100 pcs 6mm mixing cannulas Automix 2 T-Mixer yellow 25 pcs mixing cannulas optima lilac 50pcs 6mm mixing cannulas lilac 2500 pcs Bulkbox 6mm FREEPRINT® denture impact pink 1000 g FREEPRINT® denture impact pink-transparent 1000 g VITA VIONIC® BASE RESIN IMPACT pink-transparent 1000g RS VIVO Denture Impact pink 1000g VITA VIONIC® BASE RESIN IMPACT pink 1000g Freepint denture impact dark reddish pink 1000g RS VIVO Denture Impact pink transparent 1000g

    Establishment Types

    Repack or Relabel Medical Device Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer)