BEUDAMED
    FDA Registration Active 🇸🇪 Sweden

    DIRECTA AB

    Reg #: 8030938 · FEI: 3004586882 · Expires 2026
    View on FDA
    Products
    32
    Proprietary Names
    77
    Establishment Types
    4
    Classifications
    32

    Registration Details

    Registration Name
    DIRECTA AB
    Registration Number
    8030938
    FEI Number
    3004586882
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    PO BOX 723, FINVIDS VAG 8
    City
    UPPLANDS VAESBY Stockholm
    Country
    SE

    Regulatory Submissions

    510(k) Number
    K113040

    Owner / Operator

    Firm Name
    DIRECTA AB
    Operator Number
    9004750
    Address
    P.O.BOX 723, FINVIDS VAG 8
    City
    UPPLANDS VASBY
    State
    SE-NOTA
    Postal Code
    194 27
    Country
    SE
    Correspondent
    Tomas - Skeppmark

    US Agent

    Business Name
    Parkell Inc.
    Contact Name
    Yasily Ogando Roa
    Address
    300 Executive Dr
    City
    Edgewood
    State
    NY
    ZIP
    11717
    Country
    US
    Email
    [email protected]
    Phone
    631 3891560

    Products

    Device Name Product Code
    Instrument, Diamond, Dental DZP
    Reamer, Pulp Canal, Endodontic EKP
    Retainer, Matrix JEP
    Absorber, Saliva, Paper KHR
    Gauge, Depth, Instrument, Dental EIL
    Drill, Dental, Intraoral DZA
    Plaque Disclosing Agent QJC
    Crown, Preformed ELZ
    Frame, Rubber Dam EJE
    Tray, Impression, Preformed EHY
    Broach, Endodontic EKW
    Elevator, Surgical, Dental EMJ
    Cement, Dental EMA
    Guard, Disk EEJ
    Instruments, Dental Hand DZN
    Agent, Polishing, Abrasive, Oral Cavity EJR
    Resin, Root Canal Filling KIF
    Liner, Cavity, Calcium Hydroxide EJK
    Protector, Dental BRW
    Tray, Surgical, Instrument FSM
    Bur, Dental EJL
    Cup, Prophylaxis EHK
    Spreader, Pulp Canal Filling Material, Endodontic EKK
    Material, Tooth Shade, Resin EBF
    Handle, Instrument, Dental EJB
    Holder, Film, X-Ray EGZ
    File, Pulp Canal, Endodontic EKS
    Paper, Articulation EFH
    Strip, Polishing Agent EHM
    Post, Root Canal ELR
    Dam, Rubber EIE
    Plugger, Root Canal, Endodontic EKR

    Proprietary Names

    Supra disc K-reamer FenderMate Directa Strips ProxyPal FenderMatePrime DryDent Sublingual, DryDent Parotid Advance Dry Angle Tips IWANSSON MEASURING DEVICE ContacEZ Incremental Thickness Gauge S5 System S5 Rotary Files Starter Pack Paste Filler Big Apical Files S1 Plus Sendoline S3 System Rondell Directa Polycarbonate Crowns Strip Crown Forms Polycarbonate Crowns Temporary FullForm Crown Forms CoForm Crown Forms Ceramir Pediatric Crown RAINBOW RUBBER DAM FRAME TRAY CLEANER Barb Broaches Luxator® sharpening stone Luxator® brand Ceramir Bioceramic Implant Cement QuikCap Ceramir Crown & Bridge QuikMix Ceramir Crown & Bridge QuikCap Etchant Gel Snap-on Discguard Calasept Paste Needle, CalaseptPlus Flexi-Needle, Calasept Irrigation Needle Physics Forceps and Bumper Guards PrepSure Barman's Wedges ProphyCare SendoSeal MTA SendoCem MTA Calasept, CalaseptPlus CAMO DENTAL SPLINT ContacEZ Strip Tray PractiPal INSTRUMENT TRAY SYSTEM ROTOSTAND ProphyCare ProphyCup NiTi Spreader Finger Spreader Ceramir CAD/CAM block FenderWedge FixyDap Spot-it FenderPrep STIK'N PLACE FRACFINDER COLOUR CODE RINGS Ceramir Applicator TrollBag TrollByte Kimera TrollByte CHEEK RETRACTOR s-finder S-file K-file H-file TrollFoil ContacEZ kits ContacEZ Diamond Dental Strip BURN OUT POST PLASTIC PINS ANCHORAGE POST RAINBOW DENTAL RUBBER DAM & PUNCH DRY-DAM Finger Plugger Ceramir Protect LC

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer) Repack or Relabel Medical Device