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

    OSTEOPOWER SYSTEM AND ACCESSORIES

    K Number: K971692 · Decision Jun 27, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    17
    Same Product Code
    8
    Applicant Total
    27
    Review Days
    51

    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
    OSTEOPOWER SYSTEM AND ACCESSORIES
    K Number
    K971692
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.4120
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Osteomed Corp.
    Date Received
    May 7, 1997
    Decision Date
    June 27, 1997
    Product Code
    KMW
    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
    KMW Handpiece, Rotary Bone Cutting

    Similar 510(k) Clearances

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

    Oral Surgery Contra

    FDA 510(k)
    FDA Class 2 ·Dental

    Surgical Angle Handpiece, Surgical Straight Handpiece

    FDA 510(k)
    FDA Class 2 ·Dental

    OsteoMed PINNACLE Driver

    FDA 510(k)
    FDA Class 2 ·Dental

    SURGICAL HANDPIECES, MIKRO SAW HANDPIECES

    FDA 510(k)
    FDA Class 2 ·Dental

    FRIOS MICROSAW

    FDA 510(k)
    FDA Class 2 ·Dental

    E-TYPE SPEED REDUCER CONTRA ANGLE

    FDA 510(k)
    FDA Class 2 ·Dental
    View all

    Other Clearances by Osteomed Corp.

    K Number Device Name
    K151021 OsteoMed Cannulated Screw System
    K022277 OSTEOMED CRANIAL FLAP FIXATION SYSTEM
    K022887 INTERPHALANGEAL FLEXIBLE STABILIZING ROD SYSTEM
    K022886 METATARSOPHALANGEAL FLEXIBLE STABILIZING ROD SYSTEM
    K023260 1.2MM OSTEOMED AUTO-DRIVE SCREW SYSTEM
    K013618 INTRAORAL MANDIBULAR DISTRACTION SYSTEM
    K021618 OSA RIGID INTERNAL FIXATION SYSTEM
    K012486 OSTEOMED BIORESORBABLE FIXATION SYSTEM
    K010964 AUTO-DRIVE LAG SCREW SYSTEM
    K010783 2.0/2.4 CANNULATED SCREW SYSTEM
    Search all 27 clearances from Osteomed Corp. →