BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Keystone Industries

    Reg #: 2523320 · FEI: 2523320 · Expires 2026
    View on FDA
    Products
    53
    Proprietary Names
    145
    Establishment Types
    5
    Classifications
    53

    Registration Details

    Registration Name
    Keystone Industries
    Registration Number
    2523320
    FEI Number
    2523320
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    52 West King St
    City
    Myerstown
    State
    PA
    ZIP
    17067
    Country
    US

    Regulatory Submissions

    510(k) Number
    K030859

    Owner / Operator

    Firm Name
    Keystone Industries
    Operator Number
    9007845
    Address
    480 S. Democrat Road, --
    City
    Gibbstown
    State
    NJ
    Postal Code
    08027
    Country
    US

    Products

    Device Name Product Code
    Circuit, Breathing (W Connector, Adaptor, Y Piece) CAI
    Cotton, Roll EFN
    Powder, Porcelain EIH
    Crown And Bridge, Temporary, Resin EBG
    Resin, Denture, Relining, Repairing, Rebasing EBI
    Material, Impression ELW
    Eraser, Dental Stain MAU
    Material, Tooth Shade, Resin EBF
    Unit, Operative Dental, Accessories NRD
    Blade, Scalpel GES
    Plate, Base, Shellac EEA
    Evacuator, Oral Cavity EHZ
    Mouthguard, Prescription MQC
    Positioner, Tooth, Preformed KMY
    Clasp, Wire EJW
    Agent, Polishing, Abrasive, Oral Cavity EJR
    Strap, Head, Gas Mask BTK
    Paper, Articulation EFH
    Articulators EJP
    Cup, Prophylaxis EHK
    Needle, Dental DZM
    Anchor, Preformed EJX
    Agent, Tooth Bonding, Resin KLE
    Applicator, Absorbent Tipped, Non-Sterile KXF
    Mask, Surgical FXX
    Dam, Rubber EIE
    Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) HOY
    Mask, Gas, Anesthetic BSJ
    Cement, Dental EMA
    Cleaner, Ultrasonic, Medical Instrument FLG
    Wrap, Sterilization FRG
    Handpiece, Contra- And Right-Angle Attachment, Dental EGS
    Instruments, Dental Hand DZN
    Scraper, Tongue LCN
    Mouthpiece, Saliva Ejector DYN
    Bur, Dental EJL
    Unit, Syringe, Air And/Or Water ECB
    Varnish, Cavity LBH
    Syringe, Restorative And Impression Material EID
    Indirect Bonding Tray QJJ
    Handpiece, Air-Powered, Dental EFB
    Material, Impression Tray, Resin EBH
    Sealant, Pit And Fissure, And Conditioner EBC
    Applicator, Resin KXR
    Accessories, Implant, Dental, Endosseous NDP
    Wax, Dental, Intraoral EGD
    Retainer, Matrix JEP
    Tray, Fluoride, Disposable KMT
    Zinc Oxide Eugenol EMB
    Clasp, Preformed EHP
    Tray, Impression, Preformed EHY
    Fiber, Medical, Absorbent FRL
    Protector, Silicate EFX

    Proprietary Names

    Comfort Cushion Analgesia Mask Prehma Cotton Rolls Enamelite Ceramic Spray Glaze Trim II Trim Clearmet Plastopaste Superpaste Superbite NIU Bleaching Systems Prehma Sleeves Prehma Pro-Guard Towels Prehma Barrier Film Simplastic Patient Drape Simplastic Tray Cover Simplastic Uni-Cover Simplastic Sleeves FP3D Prehma Surgical Blades Prehma Sterile Disposable Scalpels Versacryl sealant Prehma HVE Tips Keystone HVE Tips KeySplint Soft Keystone Industries Clasp Wire Bosworth Prophy Powder Prehma Articulating Paper Prehma Horseshoe Articulating Paper Mizzy Pressure Indicating Paste (PIP) Mizzy PIP Aerosol Keystone Plasterless Articulator Luxury Articulator Keystone Articulators Deluxe Magnetic Articulator Prehma Prophylaxis Cups Prehma Prophylaxis Polishing Brushes Keystone Industries Prophy Cup Proflex Prehma Disposable Dental Needles Keystone Industries Mesh Strengtheners Keystone Industries Twist Plate Strengtheners Keystone Industries Grid Strengtheners Frego Strengthener Keystone Industries Lingual Bars Keystone Gelato Prophy Paste Seity Etchant Gel Bosworth Acid Etch Prehma Cotton Tipped Applicators Prehma Surgical Molded Masks Prehma Procedure masks Prehma Optima Procedure Mask Consistency Putty Prehma Rubber Dam Prehma Clear & UV Safety Glasses Bosworth Zinc Phosphate Cement Mizzy Fleck's Zinc Cement Mizzy Polycarboxylate (PCA) Cement Powder Versacryl Denture Material Diamond D Denture Material Optimize General Purpose Ultrasonic Cleaner-Liquid Optimize Tartar, Stain & Permanent Cement Remover Ultrasonic Powder Optimize General Purpose Ultrasonic Cleaner-Powder Optimize Tartar, Stain & permanent Cement Remover Ultrasonic Liquid Optimize Refresh Enzymatic Ultrasonic Instrument Cleaner Prehma Nero Disposable Prophy Angles Keystone Disposable Prophy Angles Fortis Disposable Prophy Angles Prehma Matrix Bands, Rolls & Retainers Wonder Wedges Interproximal Wedges KeyPrint KeySplint Hard Keystone Industries Tongue Scraper Flexo Disposable Saliva Ejectors Prehma Saliva Ejectors Prehma Carbide Burs KeyDenture Base Prehma Disposable Air/Water Syringe Tips Copaliner Disposable Plastic Syringes Prehma HP Mixing Tips Prehma Prebent Mixing Tips Bosworth Disposable Plastic Syringes Bosworth HP Mixing Tips Bosworth Prebent Mixing Tips KeyPrint® KeyOrtho IBT™ Proform Keystone Prophybrite Air Polishing Unit Consistency VPS Impression Material Proform Blue Tray Proform Pink Baseplate Fastray Custom Tray Material Proform ProSplint Proform Splint KeyTray KeyDenture Try-In Bosworth Pit & Fissure Sealant with Fluoride Prehma Micro Applicators KeyGuide Bite Blocks Mizzy Dr. Clyde Schuyler Formula Wax Base Plate Wax Mizzy Dr. L.A. Cohn Formula Wax Mizzy Compound Cakes and Sticks Mizzy Byte Ryte Wax Mizzy Allcezon Wax Proform EGasket Proform Duals Proform Niteguard Proform Soft EVA Prehma Matrix Retainers Original Truliner Duz-All TruRepair Ultra Fast Softone Trusoft New Truliner Mizzy Prevent Fluoride Trays Keystone Industries Disposable Fluoride Trays Gelato Disposable Fluoride Trays Mizzy Z.O.E Cement Keystone Zinc Oxide Powder Keystone Eugenol Dentusil SuperEBA Itsoclear Clasps Keystone Industries Wire Clasps Edentulous Impression Trays Stainless Steel Trays Prehma Multi Bite Impression Trays Tray Aways Disposable Impression trays Big Bite Trays BoTrays disposable impression trays Tray Adhesive Compound(TAC) Liquid and Spray Prehma Disposable Impression Trays Keymill Prehma Non Woven Sponges Prehma Cotton Filled Sponges Consistency Bite Registration Masque Silicone Lubricant & Separator Supergel Fresh Supergel Millennium Sledgehammer

    Establishment Types

    Repack or Relabel Medical Device Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device for Another Party (Contract Manufacturer)