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510(k) Data Aggregation

    K Number
    K211584
    Device Name
    Oral Surgery Contra
    Manufacturer
    Nakanishi INC.
    Date Cleared
    2021-08-19

    (87 days)

    Product Code
    KMW, EBW
    Regulation Number
    872.4120
    Why did this record match?
    Product Code :

    KMW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Oral Surgery Contra is for oral surgery. This device is driven by an electronic micromotor for oral surgery and dental implant. This device aims to transfer the rotation of the power source with various gear ratios, and moves instruments such as a surgical bur to cut the maxillary/mandibular bone during oral surgery treatment.
    Device Description
    The Ti-Max Series Oral Surgery Contra handpieces, X-SG93L, X-SG93 and X-SG25L, are contra-angle handpieces that are intended for use by a clinician in a healthcare facility/hospital setting for oral surgery and preparation for dental implant operation. The subject handpieces are available in two options: 1) fiber optic glass (X-SG93L and X-SG25L) or 2) non-optic (X-SG93). The Oral Surgery Contra handpieces are driven by a micromotor, thereby rotating surgical burs at different transmission gear ratios, to cut the maxillary/mandibular bone during oral surgery and preparation for dental implant surgery. The maximum rotational speeds of the handpieces are as follows: 120,000 min-1 for the X-SG93L and X-SG93 models; 40,000 min-1 for the X-SG25L model. The maximum rotation speed depends on the transmission gear ratios as follows: Model | Transmission gear ratio | Maximum speed ---------|-------------------------|--------------- X-SG93L | 1:3 Increasing | 120,000 min-1 X-SG93 | 1:3 Increasing | 120,000 min-1 X-SG25L | 1:1 Direct Drive | 40,000 min-1 The handpieces are manufactured using titanium and stainless steel and feature a push-button chuck mechanism. They are designed for use with surgical motors with an ISO 3964 (EN ISO 3964) type coupling system. The handpieces are designed for use with surgical burs, as follows: - X-SG93L and X-SG93: ISO 1797 Type 3 FG burs (φ1.59 - 1.6 mm) - X-SG25L: ISO 1797 Type 1 CA burs (φ2.334 - 2.35 mm). The Oral Surgery Contra handpieces are a prescription-only device.
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    K Number
    K171155
    Device Name
    Surgical Angle Handpiece, Surgical Straight Handpiece
    Manufacturer
    Nakanishi Inc.
    Date Cleared
    2017-11-21

    (215 days)

    Product Code
    KMW, EGS
    Regulation Number
    872.4120
    Why did this record match?
    Product Code :

    KMW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Surgical Straight/Angle Handpiece Series is intended for use by licensed professionals for oral surgical and dental use. Typical uses include sectioning and removal of wisdom teeth, oral surgery (such as root tip resection. bone removal, bone shaping) and implant treatment (such as drilling the maxilla and mandible).
    Device Description
    The Surgical Straight/Angle Handpiece features an allowable maximum motor speed at 40,000min-1. The handpieces are provided non-optic. The handpieces are designed with an angle appearance and a straight appearance. Models are available to be connected directly onto motors compliant to ISO 3964. All the devices are manufactured using stainless steel with some aluminum, and use a Bur Lock Ring Chuck Design. Available models include: Straight (1:1)- SGS-E, SGS-ES; Straight (1:2) - SGS-E2G, SGS-E2S; Angled (1:1) - SGA-E, SGA-ES; Angled (1:2) - SGA-E2G, SGA-E2S.
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    K Number
    K162544
    Device Name
    OsteoMed PINNACLE Driver
    Manufacturer
    OSTEOMED
    Date Cleared
    2017-04-04

    (204 days)

    Product Code
    KMW
    Regulation Number
    872.4120
    Why did this record match?
    Product Code :

    KMW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PINNACLE Driver is intended for driving screws and for drilling into bone, in conjunction with dental, orthognathic, and mandibular surgical procedures.
    Device Description
    The PINNACLE Driver is a handheld, cordless, software driven, battery operated driver for high speed insertion of screws and drilling of pilot holes. The device operates in both the forward and reverse directions. A sterile, single use battery powers the device and is intended for use solely with the PINNACLE Driver. Accessories for the PINNACLE Driver include hex shank drills and driver stems. The optional driver stems are reusable while the drills are single use. The PINNACLE Driver may be sterilized individually wrapped in two layers of 1-ply polypropylene wrap or unwrapped in a sterilization organizational tray inside a rigid sterilization container, which is available from OsteoMed. The PINNACLE Driver is intended for use in a healthcare facility/hospital for use by a clinician. The PINNACLE is a prescription device. The PINNACLE Driver and lithium battery is made of medical grade stainless steel, aluminum, silicone, PEEK, gold plated brass, and medical plastic. The driver stems and drills are made of medical grade stainless steel. The sterilization organizational trays and rigid sterilization containers are made of aluminum. The PINNACLE Driver is a battery operated driver/drill that operates in the both in the forward and reverse directions. The PINNACLE Driver contains torque limiting software to prevent over-torquing and stripping of screws in drive mode.
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    K Number
    K080939
    Device Name
    SURGICAL HANDPIECES, MIKRO SAW HANDPIECES
    Manufacturer
    W & H DENTALWERK BUERMOOS GMBH
    Date Cleared
    2008-07-29

    (117 days)

    Product Code
    KMW
    Regulation Number
    872.4120
    Why did this record match?
    Product Code :

    KMW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Surgical treatment of dental hard tissue in oral and maxillo-facial surgery
    Device Description
    Surgical handpieces and Mikro saw handpieces have been designed to transmit the rotational movement of the motor axle to the shank of a bur or a saw blade which will be inserted into the output end of the handpiece. They fit all surgical drive units and surgical motors with a coupling system according to ISO 3964. The user manual points out the recommendations for the different handpiece types covered by this application.
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    K Number
    K994298
    Device Name
    FRIOS MICROSAW
    Manufacturer
    FRIADENT GMBH
    Date Cleared
    2000-02-18

    (59 days)

    Product Code
    KMW
    Regulation Number
    872.4120
    Why did this record match?
    Product Code :

    KMW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The FRIOS MicroSaw is indicated for use in preparing bone in conjunction with dental and craniofacial surgical procedures.
    Device Description
    The FRIOS MicroSaw is a series of instruments used in preparing bone in dental and craniofacial surgical procedures. The MicroSaw components are used in conjunction with the FRIOS Contra-Angle and Straight Handpieces. The MicroSaw consists of the disc for cutting bone, the drill for predrilling techniques and the chisel for elevating and luxating bone. The FRIOS MicroSaw also includes a protector which is attached to the handpiece which is designed to protect the soft tissue and limit the cutting depth.
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    K Number
    K971692
    Device Name
    OSTEOPOWER SYSTEM AND ACCESSORIES
    Manufacturer
    OSTEOMED CORP.
    Date Cleared
    1997-06-27

    (51 days)

    Product Code
    KMW
    Regulation Number
    872.4120
    Why did this record match?
    Product Code :

    KMW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Osteomed Corporation intends to market the OsteoPower System and Accessories for drilling or cutting bone or teeth, and for driving screws and/or pins and wires into bone, in conjunction with dental, craniofacial, craniotomies, orthognathic, spinal, mandibular, hand, foot, wrist, and extremity reconstruction surgical procedures.
    Device Description
    OsteoPower System and Accessories
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    K Number
    K970953
    Device Name
    E-TYPE SPEED REDUCER CONTRA ANGLE
    Manufacturer
    NSK NAKANISHI, INC.
    Date Cleared
    1997-04-15

    (29 days)

    Product Code
    KMW
    Regulation Number
    872.4120
    Why did this record match?
    Product Code :

    KMW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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