BEUDAMED
    FDA Registration Active 🇺🇸 United States

    BISCO, INC.

    Reg #: 1420052 · FEI: 1420052 · Expires 2026
    View on FDA
    Products
    15
    Proprietary Names
    94
    Establishment Types
    5
    Classifications
    15

    Registration Details

    Registration Name
    BISCO, INC.
    Registration Number
    1420052
    FEI Number
    1420052
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    1100 WEST IRVING PARK RD.
    City
    Schaumburg
    State
    IL
    ZIP
    60193
    Country
    US

    Regulatory Submissions

    510(k) Number
    K853001

    Owner / Operator

    Firm Name
    BISCO, INC.
    Operator Number
    1420052
    Address
    1100 WEST IRVING PARK RD., --
    City
    Schaumburg
    State
    IL
    Postal Code
    60193
    Country
    US

    Products

    Device Name Product Code
    Cement, Dental EMA
    Syringe, Restorative And Impression Material EID
    Adhesive, Bracket And Tooth Conditioner, Resin DYH
    Varnish, Cavity LBH
    Coating, Filling Material, Resin EBD
    Material, Tooth Shade, Resin EBF
    Agent, Tooth Bonding, Resin KLE
    Aligner, Sequential NXC
    External Cleaning Solution PME
    Powder, Porcelain EIH
    Resin, Denture, Relining, Repairing, Rebasing EBI
    Applicator, Resin KXR
    Wax, Dental, Intraoral EGD
    Sealant, Pit And Fissure, And Conditioner EBC
    Liner, Cavity, Calcium Hydroxide EJK

    Proprietary Names

    Uni-Etch Accessories Auto-Mix Cannula Tips Flowable Syringe Tips Etch-37 Accessories NEEDLE BRUSH TIPS DUAL-SYRINGE INTRA-ORAL MIXING TIPS DUAL-SYRINGE ROOT CANAL MIXING TIPS UNIT-DOSE DISPENSING SYRINGE AELITEFLO ANGLED TIPS SELECT HV ETCH ACCESSORIES BLUE TIP DUAL-SYRINGE DISPENSER DUAL-SYRINGE STATIC MIXING TIP NEEDLE TIP/PLUG L/V TIP/PLUG AELITEFLO LV TIPS AELITE AESTHETIC ENAMEL ETCH-37 with BAC SELECT HV ETCH with BAC UNI-ETCH UNI-ETCH with BAC SELECT HV ETCH ETCH-37 ORTHO-ONE LIQUID ETCHANT Choice 2 DC Z-PRIME PLUS AQUA-PREP F All-Bond Universal w/BAC ZirClean PORCELAIN ETCHANT 9.5% PORCELAIN ETCHANT 4% BARRIER GEL LIGHT CORE ONE-STEP PLUS ONE-STEP Z-CEM SA BISCEM TheraCem TheraCem Ca AELITE LS PACKABLE ENAMEL AELITEFLO TESCERA FLO Quantium BISFIL 2B FORTIFY MODELING RESIN MIXING PAD DISPOSABLE MIXING WELLS RESINVOIR MIXING WELL BISCO APPLICATORS DISPOSABLE SPATULAS HANDLES BISCO BRISTLE APPLICATOR BRUSH TIPS eCement (Light-Cured Resin Cement) CHOICE 2 PORCELAIN BONDING RESIN CHOICE Universal Primer TESCERA OPAQUER POWDER TESCERA OPAQUER/SCULPTING RESIN PORCELAIN PRIMER OPAQUER D/C BIS-SILANE ALL-BOND 3 ALL-BOND UNIVERSAL DUO-LINK DUO-LINK UNIVERSAL eCement (Dual-Cured Resin Cement) AELITE LS PACKABLE DENTIN AELITE LS POSTERIOR THERACAL LC eCEMENT Try-In-Paste Choice 2 Try-in-Paste Core-Flo DC Lite CORE-FLO DC AELITE ALL-PURPOSE BODY CHARACTERIZATION TINT TheraBase Ca TheraBase TheraCal PT PRE-BOND D/E RESIN ALL-BOND 2 ALL-BOND 3 RESIN CAVITY CLEANSER TESCERA INCISAL TESCERA COLOR MODIFIER TESCERA DENTIN TESCERA BODY TESCERA ROOT DENTIN TESCERA ENAMEL TESCERA CHROMA

    Establishment Types

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