BEUDAMED
    FDA Registration Active 🇺🇸 United States

    PLASDENT CORP.

    Reg #: 2029234 · FEI: 1000220911 · Expires 2026
    View on FDA
    Products
    27
    Proprietary Names
    31
    Establishment Types
    2
    Classifications
    27

    Registration Details

    Registration Name
    PLASDENT CORP.
    Registration Number
    2029234
    FEI Number
    1000220911
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    969 PRICE ST.
    City
    POMONA
    State
    CA
    ZIP
    91767
    Country
    US

    Regulatory Submissions

    510(k) Number
    K133070

    Owner / Operator

    Firm Name
    PLASDENT CORP.
    Operator Number
    9010801
    Address
    969 PRICE ST., --
    City
    Pomona
    State
    CA
    Postal Code
    91767
    Country
    US
    Correspondent
    LARRY C WEI

    Products

    Device Name Product Code
    Material, Impression Tray, Resin EBH
    Cotton, Roll EFN
    Mask, Surgical FXX
    Syringe, Restorative And Impression Material EID
    Tray, Impression, Preformed EHY
    Handle, Instrument, Dental EJB
    Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) HOY
    Toothbrush, Manual EFW
    Unit, Syringe, Air And/Or Water ECB
    Needle, Dental DZM
    Dental Barriers And Sleeves PEM
    Mouthpiece, Saliva Ejector DYN
    Unit, Operative Dental, Accessories NRD
    Evacuator, Oral Cavity EHZ
    Gauze / Sponge,Nonresorbable For External Use NAB
    Non-Surgical Gown OEA
    Absorber, Saliva, Paper KHR
    Floss, Dental JES
    Holder, Film, X-Ray EGZ
    Tape, Measuring, Rulers And Calipers FTY
    Retractor, All Types EIG
    Mirror, Mouth EAX
    Applicator, Absorbent Tipped, Non-Sterile KXF
    Chair, Dental, Without Operative Unit NRU
    Cleanser, Denture, Over The Counter EFT
    Protector, Dental BRW
    Pick, Massaging JET

    Proprietary Names

    IMPRESSION TRAY,RESIN,BITE TRAY,IMPRESSION TRAY MATERIAL Cotton Rolls, cotton roll dispenser, cotton roll applicators EARLOOP MASKS, FACE MASKS Plastic Impression Syringes, Plastic injectors, Material Carrier, Syringe Tips, Mixing & Intraoral tips, Dispenser Guns Preformed Impression Trays Valve, Snap on tips, Lever, SE Tip Accessories Face Shield, Plastic Shield, Safety Eye wears, protective eye wears, eye, ophthalmic PLASTIC BRUSHES, PLASTIC APPLICATORS TOOTHBRUSH, MANUAL-MICRO BRUSH, MINI BRUSH UNIT,SYRINGE,AIR AND/OR WATER-SYRINGE COVERS, TIP COVERS DENTAL NEEDLE TIPS, BENT NEEDLE TIPS, IRRIGATION NEEDLE TIPS Dental Barriers & Sleeves MOUTHPIECE, SALIVA EJECTOR, PLASTIC TUBES, ASPIRATOR TIPS DENTAL ACCESSORIES,Oral cup,Water Bottle,Vacuum Canister,Mixing Tip,Plastic Boxes,Matrices,Aligner Seater,Connector Dam frame,overglove,Barrier apron,Waste bag,Inserts,Capsule applier,Brush handle& tips,Finger ruler,Matrix,Splash shield Foam insert,Cartridge connector,Syringe tips,Intraoral tip,Plug,Core Forms,Polishing item,Tube&Plug,Indicator tape&strip Traps,Wraps, Model cartridge,Model Former, Mixing well, Pouch, Dappen dishes, Plastic sterilization tubing, Spatula,Bowl EVACUATOR, ORAL CAVITY-EVACUATOR TIPS, HVE Tip Accessories, Adaptors GAUZE/SPONGE, NONRESORBABLE FOR EXTERNAL USE-GAUZE/SPONGE, COTTON SPUNLACE SPONGES Non-Woven Isolation Gown & Accessories, Non-Surgical Isolation Gowns Tray Paper, Bib, Tissue Headrest Cover, Face & Chest Cover Dental Floss Plastic Film Holder,Bite Block,Film carrier,Barrier envelopes, Aligning system,Snap film holder,Sensor holder,Film Mount Tape, Measuring, Rulers & Calipers, Finger Ruler Cheek Retractors, Props, Retractor-all types Dental Mirror, Mouth Mirror, Photography Mirror, Photo Contrastor Cotton Tip Applicators, Micro Applicators, Applicator Tips, Microbrush Applicators Chair, Chair stools & accessories, plastic covers, plastic tubing & sleeves, barrier films, plastic bags Denture Cleanser PROTECTOR, DENTAL - Mouth Props, Mouth Night Guard, Bleaching Trays, Mouth Guards Pick, Soft Picks, Toothpicks,Plastic Wedges

    Establishment Types

    Repack or Relabel Medical Device Complaint File Establishment per 21 CFR 820.198