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510(k) Data Aggregation

    K Number
    K173440
    Device Name
    Carriere SLX 3D Clear
    Manufacturer
    Ortho Organizers, Inc.
    Date Cleared
    2018-03-08

    (122 days)

    Product Code
    NJM
    Regulation Number
    872.5470
    Why did this record match?
    Applicant Name (Manufacturer) :

    Ortho Organizers, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Carriere SLX 3D Clear orthodontic ceramic bracket system is in the movement of teeth during orthodontic treatment.
    Device Description
    The Carriere SLX 3D Clear is a ceramic passive self-ligating orthodontic bracket system that directly bonds to the teeth to provide a treatment solution for patients with malocclusions of primary, permanent, or mixed dentition. Each bracket is comprised of four individual components; a polycrystalline alumina door, a polycrystalline alumina base, and two 304 stainless steel springs. The two springs are laser welded together and borne by the springs are the force giving mechanism in the bracket system, providing tactile and audible feedback for the clinician when opening and closing the door. The springs also provide a mechanism to keep all four components assembled throughout treatment. Because the Carriere SLX 3D Clear is a passive self-ligating bracket system, wherein the door portion of the bracket opens and closes to alternatively expose and conceal the archwire slot, the door replaces the need for a conventional ligature and retains the archwire while providing minimal friction throughout the treatment process. The bracket system is intended to be used throughout orthodontic treatment with an accompanying archwire to move the teeth to the desired occlusion by the clinician. The Carriere SLX 3D Clear bracket has an integral hook design, which allows for the attachment of elastics and other alternate force giving mechanisms to assist the clinician in producing the desired tooth movement. The bonding surface of the bracket has a mechanical undercut design, allowing the bracket to retain the adhesive and bond to the facial surface of the tooth. The application and removal of the Carriere SLX 3D Clear orthodontic ceramic bracket is similar to that of other orthodontic ceramic brackets. It requires orthodontic adhesive for bonding and standard orthodontic tools and techniques for de-bonding.
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    K Number
    K160720
    Device Name
    Carriere Motion Clear Class II
    Manufacturer
    ORTHO ORGANIZERS, INC.
    Date Cleared
    2016-11-28

    (257 days)

    Product Code
    DYW, EJF
    Regulation Number
    872.5470
    Why did this record match?
    Applicant Name (Manufacturer) :

    ORTHO ORGANIZERS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Carriere Motion Clear Class II orthodontic appliance is intended to provide orthodontic movement and alignment of teeth during orthodontic treatment for Class II cases with symmetrical malocclusions and Class I cases with mesially positioned maxillary molars.
    Device Description
    The Carriere Motion Clear Class II is a direct bond, esthetic, orthodontic appliance that attaches the maxillary canine or premolar to molar to provide a treatment solution for patients with malocclusions of primary, permanent or mixed dentition. The orthodontic appliance is a two-piece design comprised of an integrated polyethersulfone, a clear thermoplastic, anterior pad and rigid arm that connects to a 17-4 stainless steel posterior pad in a "ball and socket" relationship. The orthodontic appliance is intended to be used at the beginning of orthodontic treatment when there are no competing forces in the mouth. The device allows the distalization of the posterior segments. The Carriere Motion Clear Class II corrects the posterior occlusion to a Class I platform first by rotating and uprighting the maxillary molars while distalizing the posterior segment, from canine or premolar to molars. The orthodontic appliance independently moves each posterior segment, from canine or premolar to molar, as a unit. The anterior pad includes an integrated hook which allows for the attachment of elastics to the lower molars. The posterior pad bonds to the facial surface of the teeth and is made of 17-4 stainless steel. The pad serves as the socket in the ball and socket relationship with the plastic arm. The ball and socket has built-in stops that allow the molars to move directly to their desired position and are intended to prevent any unwanted over rotation or tipping. The Carriere Motion Clear Class II's application and removal is similar to that of a plastic orthodontic bracket. It requires orthodontic adhesive for bonding and standard orthodontic tools and techniques for debonding.
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    K Number
    K110335
    Device Name
    CERAMIC BRACKETS
    Manufacturer
    ORTHO ORGANIZERS, INC.
    Date Cleared
    2011-05-19

    (104 days)

    Product Code
    NJM
    Regulation Number
    872.5470
    Why did this record match?
    Applicant Name (Manufacturer) :

    ORTHO ORGANIZERS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    These devices are intended for the correction of orthodontic malocclusions as diagnosed by a dentist or orthodontist. They are used to transmit and provide axial directional control to the kinetic energy from an orthodontic archwire, for movement of individual teeth for treatment. These ceramic brackets will be used for correction of malocclusions as diagnosed and overseen by trained practitioners of orthodontics. These brackets will be directly bonded to teeth; will have interface with the archwire to direct applied forces. These devices are intended for single use only and are not delivered in a sterile state.
    Device Description
    The Ceramic Bracket line of products are single-use devices intended for use in conjunction with comprehensive orthodontics to control the movement of individual teeth. These one-piece ceramic brackets are comprised of polycrystalline aluminum oxide. The general geometric composition of these devices is made of archwire slot, tie wings, and a pad (which provides a bonding surface). The archwire slot is a channel through the bracket used to engage the archwire. The tie wings are small hook shaped protrusion use as an anchor point for the ligatures work by tying the archwire into the archwire slot. The geometry of the pad is such that the bracket has a stable footprint. The pad is coated with aluminum oxide particles to facilitate bracket bonding with orthodontic adhesives. These brackets are comprised of several geometries that vary from bracket to bracket, corresponding to the teeth they are intended for. These geometries contribute to the fit of the bracket to the tooth and also impart the axial control of the energy from the archwire.
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    K Number
    K061266
    Device Name
    ORTHO ORGANIZERS TEMPORARY ORTHODONTIC ANCHOR
    Manufacturer
    ORTHO ORGANIZERS, INC.
    Date Cleared
    2006-07-31

    (87 days)

    Product Code
    OAT
    Regulation Number
    872.3640
    Why did this record match?
    Applicant Name (Manufacturer) :

    ORTHO ORGANIZERS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Ortho Organizers Temporary Orthodontic Anchor is intended to provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodonic movement of teeth.
    Device Description
    The Ortho Organizers Temporary Orthodontic Anchor is a device that is temporarily implanted in the alveolar ridge to provide a fixed anchorage point for various orthodontic tooth movements. It is a single-piece design that features a threaded shaft and a low profile proximal head. The head incorporates a button and undercut that serves as an attachment point. The tapered conical section below the button incorporates a transverse circular opening which also serves as an attachment point. Vertical flats below the conical section enable use of tools to turn the device into its fully implanted position. The head terminates in a collar that separates the attachment points from the threaded portion of the device. The device is available with a short collar or a long collar to accommodate variations in soft tissue thickness. The device is made of titanium alloy conforming to the requirements of ASTM F 136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications. The device will be sold non-sterile and is intended to be sterilized prior to use.
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