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

    SYNEA-HS HIGH SPEED-HANDPIECE

    K Number: K992011 · Decision Sep 10, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    89
    Registration Numbers
    89
    Same Product Code
    260
    Applicant Total
    69
    Review Days
    87

    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
    SYNEA-HS HIGH SPEED-HANDPIECE
    K Number
    K992011
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.4200
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    A-Dec, Inc.
    Date Received
    June 15, 1999
    Decision Date
    September 10, 1999
    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 A-Dec, Inc.

    K Number Device Name
    K213932 A-dec 300, A-dec 500
    K133776 A-DEC/W&H ELECTRIC HANDPIECE MOTOR
    K102234 A-DEC 200 DENTAL SYSTEM
    K100647 A-DEC/W&H SYNEA SONIC SCALER HANDPIECE, MODELS ZA-55, ZA-55 L, ZA-55 LM, ZA-55M, SF1LM
    K082716 A-DEC/W&H ALEGRA AIR-DRIVEN HIGHSPEED HANDPIECE, MODEL TE-97, TE-98, A-DEC/W&H ALEGRA HANDPIECE ATTACHMENT, MODEL HE-43
    K082827 A-DEC/W&H PROFIN RECIPROCATING CONTRA-ANGLE HANDPIECE ATTACHMENT
    K082985 A-DEC 334/335 DELIVERY SYSTEM
    K070663 A-DEC/W&H SYNEA AIR-DRIVEN HIGHSPEED HANDPIECE, MODEL TA-98, TA-97, A-DEC/W&H SYNEA HANDPIECE ATTACHMENT
    K051657 A-DEC SELF-CONTAINED WATER SYSTEM
    K032757 A-DEC SELF-CONTAINED WATER SYSTEM, MODEL 0.7 LITER BOTTLE & 2 LITER BOTTLE
    Search all 69 clearances from A-Dec, Inc. →