BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇨🇦 Canada

    K-SPRAY, MODEL 085-2715

    K Number: K062418 · Decision Oct 19, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    89
    Registration Numbers
    89
    Same Product Code
    260
    Applicant Total
    9
    Review Days
    62

    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
    K-SPRAY, MODEL 085-2715
    K Number
    K062418
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.4200
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Scican
    Date Received
    August 18, 2006
    Decision Date
    October 19, 2006
    Product Code
    EFB
    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
    EFB Handpiece, Air-Powered, Dental

    Similar 510(k) Clearances

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

    High speed air turbine handpiece

    FDA 510(k)
    FDA Class 1 ·Dental

    Dental air-motor handpiece (TM-203B2, TM-203M4, TM-205B2, TM-205M4, TM-IS, TM-ES, TM-SG20, TM-X25, TM-BB, TM-IC, TM-RA41)

    FDA 510(k)
    FDA Class 1 ·Dental

    Synea Fusion Handpieces (Intensiv & Profin)

    FDA 510(k)
    FDA Class 1 ·Dental

    Dental Handpiece (Model: J6-126, J6-136, SH11W2, SH11W3, W401LW, W15LW, W142LW, W11L)

    FDA 510(k)
    FDA Class 1 ·Dental

    High-speed Air Turbine Handpieces (SCHG01, SCHG03, SCHG18, SCHF19, SCHF22), Dental Low Speed Handpieces including Straight and Geared Angle Handpieces and Air Motors (Straight Handpieces: SCHD05-S, SCHD16-S, SCHD17-S, SCHD24-S, SCHD27-S Geared Angle Handpieces: SCHD05-C, SCHD06-C, SCHD16-C, SCHD17-C, SCHD24-C, SCHD27-C, SCHD29-S, SCHB4, SCHB5, SCHB20, SCHB64 Air Motors: SCHD16-M, SCHD17-M, SCHD24-M, SCHD27-M)

    FDA 510(k)
    FDA Class 1 ·Dental

    Air Powered Tooth Polishing System (Perio-Mate); Air Powered Tooth Polishing System (Perio Mate Nozzle Tip)

    FDA 510(k)
    FDA Class 1 ·Dental
    View all

    Other Clearances by Scican

    K Number Device Name
    K021064 QUANTIM 16 AUTOCLAVE
    K983679 STATIM 5000 CASSETTE AUTOCLAVE
    K964691 TCB TEMPORARY CROWN AND BRIDGE MATERIAL
    K962179 STAT IM 5000 CASSETTE AUTOCLAVE
    K944036 STERIMASTER AUTOCLAVE
    K945142 POLYSIL (VINYL POLYSILOXAN IMPRESSION MATERIAL)
    K915054 STATIM CASSETT AUTOCLAVE, MODIFICATION
    K910241 STATIM CASSETTE AUTOCLAVE