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510(k) Data Aggregation

    K Number
    K202857
    Device Name
    ClearPath Aligner
    Manufacturer
    ClearPath Orthodontics Ltd
    Date Cleared
    2021-01-05

    (99 days)

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

    ClearPath Orthodontics Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ClearPath Aligner is a series of clear, lightweight, plastic appliances indicated for the correction of dental malocclusion in patients with permanent dentition (i.e. all second molars). The ClearPath Aligner positions teeth by way of continuous gentle force.
    Device Description
    The ClearPath clear aligner is comprised of a series of clear, thin, thermoformed removable aligner trays that are designed to correct tooth malocclusions without the use of conventional wire and bracket orthodontic technology. The aligners are provided non-sterile and are customized for each patient according to the dental clinician's prescription. The dental health professional (dentist/orthodontist) takes provides physical or scanned impressions of the patient's teeth to ClearPath. A digital setup of either the scanned impression or a scan of the physical impression is sent to the clinician for approval. Upon approval, molds are then created with 3D-printing technology and the clear aligners are thermoformed on the molds and laser marked. The finished, customized aligners are provided to the dental health care professional who provides them to the patient, confirming fit and design. The aligner trays are held in place by pressure and can be removed by the patients at any time.
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    K Number
    K162609
    Device Name
    ClearPath Aligner
    Manufacturer
    ClearPath Orthodontics Ltd
    Date Cleared
    2017-07-06

    (290 days)

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

    ClearPath Orthodontics Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ClearPath Aligner is a series of clear, lightweight, plastic appliances indicated for the correction of dental malocclusion in patients with permanent dentition (i.e. all second molars). The ClearPath Aligner is intended to position teeth by way of continuous gentle force.
    Device Description
    ClearPath Orthodontics uses clear, thin, thermoformed plastic material for the manufacture of its ClearPath Aligner. The aligners are provided non-sterile and are customized for each patient according to the molds provided by the treating dentist or orthodontist. Depending on the patient need and the treatment plan, a series of aligners may be used. The duration of use for each aligner is 14 days and it is to be worn except during meals.
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