BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    PROACTIVE CARE PROPHYLAXIS PASTE WITH FLUORIDE

    K Number: K033785 · Decision Jun 18, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    142
    Registration Numbers
    142
    Same Product Code
    76
    Applicant Total
    10
    Review Days
    197

    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
    PROACTIVE CARE PROPHYLAXIS PASTE WITH FLUORIDE
    K Number
    K033785
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.6030
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Discus Dental, Inc.
    Date Received
    December 4, 2003
    Decision Date
    June 18, 2004
    Product Code
    EJR
    Advisory Committee
    Dental
    Review Advisory Committee
    DE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    EJR Agent, Polishing, Abrasive, Oral Cavity

    Similar 510(k) Clearances

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

    AIR-FLOW PLUS Prophylaxis powder

    FDA 510(k)
    FDA Class 1 ·Dental

    WHIP MIX PREPPIES PLUS

    FDA 510(k)
    FDA Class 1 ·Dental

    NUPRO SENSODYNE PROPHYLAXIS PASTE WITH NOVAMIN

    FDA 510(k)
    FDA Class 1 ·Dental

    OSSPRAY SYLC CR

    FDA 510(k)
    FDA Class 1 ·Dental

    BUTLER CALCI-FLOR PROPHYLAXIS PASTE

    FDA 510(k)
    FDA Class 1 ·Dental

    REMIN PRO

    FDA 510(k)
    FDA Class 1 ·Dental
    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
    K040053 PRECISION VPS IMPRESSION MATERIAL
    K033381 DISCHEM CHEMICAL PROPORTIONING & DISPENSING SYSTEM FOR USE WITH CETYLCIDE-G CONCENTRATE AND DILUENT, AQUARIUS MODEL
    K030776 MEGA BITE REGISTRATION - DENTAL BITE REGISTRATION MATERIAL
    K023748 FLASH-LITE II LED DENTAL CURING LIGHT
    K022184 FLASH-LITE LED DENTAL CURING LIGHT