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510(k) Data Aggregation

    K Number
    K162046
    Device Name
    MINNE TIES MMF Suture System
    Manufacturer
    SUMMIT MEDICAL, INC.
    Date Cleared
    2017-04-11

    (260 days)

    Product Code
    DYX
    Regulation Number
    872.4600
    Why did this record match?
    Product Code :

    DYX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MINNE TIES™ MMF Suture System is an adjustable flexible plastic band that wraps between and around a tooth to create an anchorage point for maxilla-mandibular fixation and immobilization. MINNE TIES™ MMF Suture System is suitable for: - Pre-operative fixation - Per-operative fixation - Short-term (up to 3 weeks) fixation for minimally displaced fractures - Splintage post jaw dislocation
    Device Description
    The MINNE TIES™ MMF Suture System contains: - Four (4) 1.0mm sized sutures - Seven (7) 0.7mm sized sutures - One (1) 0.5mm Sized suture and are used to establish maxilla-mandibular fixation (MMF) and immobilization by applying independently balanced series of sutures bilaterally between and/or around the teeth in the interdental space (i.e. triangular apical embrasure). The sutures provide a stabilizing occlusive force allowing for short term (up to 3 weeks) fixation for minimally displaced fractures for pre-operative and per-operative fixation and splintage post jaw dislocation. An Introducer is used to advance sutures between and/or around the teeth. A cheek retractor is included with the system to organize the ties during the procedure. The MINNE TIES™ MMF Sutures are made of polypropylene, polyester and stainless steel. The cheek retractor is made of polypropylene.
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    K Number
    K061271
    Device Name
    ERCH ARCH BAR, MODEL 38-690-00
    Manufacturer
    KLS-MARTIN L.P.
    Date Cleared
    2006-06-30

    (56 days)

    Product Code
    DYX
    Regulation Number
    872.4600
    Why did this record match?
    Product Code :

    DYX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Erich Arch Bar is indicated for use in intermaxillary and maxillo-mandibular fixation.
    Device Description
    The Erich Arch Bar is made of fully annealed electro polished stainless steel which is affixed temporarily to the teeth by an oral surgeon or dentist with ligature wire. The installed device provides temporary jaw immobilization.
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    K Number
    K031207
    Device Name
    SAFETY RELEASE ARCH BAR KIT
    Manufacturer
    CASEY SURGICAL, LLC
    Date Cleared
    2003-07-15

    (90 days)

    Product Code
    DYX
    Regulation Number
    872.4600
    Why did this record match?
    Product Code :

    DYX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Casey Surgical Safety Release ™ Arch Bar Kit is indicated for use in intermaxillary and maxillo-mandibular fixation.
    Device Description
    The Casey Surgical Safety Release ™ Arch Bar Kit is made of four components which are installed by an oral surgeon or dentist along with ligature wires. The installed device provides temporary jaw immobilization. The device incorporates a safety release mechanism.
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    K Number
    K030605
    Device Name
    RAPID IMF
    Manufacturer
    ZYGOMATICS LTD.
    Date Cleared
    2003-06-27

    (122 days)

    Product Code
    DYX
    Regulation Number
    872.4600
    Why did this record match?
    Product Code :

    DYX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Rapid IMF is an adjustable flexible plastic band that wraps around a tooth to create an anchorage point for maxillo-mandibular fixation and immobilisation (similar to an orthodontic band). Rapid IMF is suitable for: - Pre-operative fixation - Per-operative fixation - Short-term (up to 3 weeks) fixation for minimally displaced fractures - Splintage post jaw dislocation
    Device Description
    The Rapid IMF is an adjustable flexible plastic band that wraps around a tooth to create an anchorage point for maxillo-mandibular fixation and immobilisation (similar to an orthodontic band).
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    K Number
    K990212
    Device Name
    LOCKJAW 15 MINUTE INTERMAXILLARY FIXATION SYSTEM,MODEL LJ100-00
    Manufacturer
    DOCTOR'S RESEARCH GROUP, INC.
    Date Cleared
    1999-09-14

    (235 days)

    Product Code
    DYX
    Regulation Number
    872.4600
    Why did this record match?
    Product Code :

    DYX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DRG LockJaw™ 15 Minute Intermaxillary Fixation System is intended for secondary intermaxillary fixation in the treatment of maxillary and mandibular fractures, in elective orthognathic surgery and in the stabilization of dental and dentoalveolar injuries.
    Device Description
    DRG LockJaw™ 15 Minute Intermaxillary Fixation System
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    K Number
    K991004
    Device Name
    SYNTHES QUICK LOCK IMF SYSTEM
    Manufacturer
    SYNTHES (USA)
    Date Cleared
    1999-06-23

    (90 days)

    Product Code
    DYX, DAT
    Regulation Number
    872.4600
    Why did this record match?
    Product Code :

    DYX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Synthes Quick Lock™ IMF System is indicated for use in intermaxillary and maxillo-mandibular fixation.
    Device Description
    The Synthes Quick Lock ™ IMF System consists of brackets, arch bars and instrumentation which are used to facilitate temporary jaw immobilization. The Synthes Quick Lock ™ Bracket is a dental bracket that provides an attachment point for MMF wires and elastics. It incorporates a high tensile strength fiber that circumdentially attaches the bracket to the dentition. The Quick Lock ™ Arch Bar and Arch Bar Bracket provide additional support to the dental arch.
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