BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    DISCHEM CHEMICAL PROPORTIONING & DISPENSING SYSTEM FOR USE WITH CETYLCIDE-G CONCENTRATE AND DILUENT, AQUARIUS MODEL

    K Number: K033381 · Decision Jan 27, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    39
    Registration Numbers
    39
    Same Product Code
    63
    Applicant Total
    10
    Review Days
    97

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    DISCHEM CHEMICAL PROPORTIONING & DISPENSING SYSTEM FOR USE WITH CETYLCIDE-G CONCENTRATE AND DILUENT, AQUARIUS MODEL
    K Number
    K033381
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.6885
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Discus Dental, Inc.
    Date Received
    October 22, 2003
    Decision Date
    January 27, 2004
    Product Code
    MED
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MED Sterilant, Medical Devices

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (MED), ordered by most recent decision date.

    SYSTEM 1E Liquid Chemical Sterilant Processing System, Model P6700; SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900

    FDA 510(k)
    FDA Class 2 ·General Hospital

    SYSTEM 1E Liquid Chemical Sterilant Processing System (P6500); SYSTEM 1 endo Liquid Chemical Sterilant Processing System (P6800); SYSTEM 1 endo Liquid Chemical Sterilant Processing System (P6900)

    FDA 510(k)
    FDA Class 2 ·General Hospital

    SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900

    FDA 510(k)
    FDA Class 2 ·General Hospital

    SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6800, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900, S40 Sterilant Concentrate

    FDA 510(k)
    FDA Class 2 ·General Hospital

    SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6800, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900, S40 Sterilant Concentrate

    FDA 510(k)
    FDA Class 2 ·General Hospital

    SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6800, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900, S40 Sterilant Concentrate

    FDA 510(k)
    FDA Class 2 ·General Hospital
    View all

    Other Clearances by Discus Dental, Inc.

    K Number Device Name
    K073518 FLASHLITE REBEL*
    K062176 RELIEF ACP ORAL CARE GEL
    K052090 SPLASH! IMPRESSION MATERIAL DEVICE
    K051776 PROTEGE ULTRASONIC INSERT
    K033785 PROACTIVE CARE PROPHYLAXIS PASTE WITH FLUORIDE
    K040053 PRECISION VPS IMPRESSION MATERIAL
    K030776 MEGA BITE REGISTRATION - DENTAL BITE REGISTRATION MATERIAL
    K023748 FLASH-LITE II LED DENTAL CURING LIGHT
    K022184 FLASH-LITE LED DENTAL CURING LIGHT