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510(k) Data Aggregation

    K Number
    K211427
    Device Name
    CREOKORREKT Aligners
    Date Cleared
    2022-10-13

    (524 days)

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

    CreoDent Prosthetics LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The CREOKORREKT Aligner is indicated for the treatment of tooth malocclusion in patients with permanent dentition (i.e. all second molars). The aligner positions teeth by way of continuous gentle force.
    Device Description
    CREOKORREKT Aligners consist of a series of dentist-prescribed, thin, clear, thermoformed polyurethane and copolyester orthodontic appliances. The aligners provide gentle continuous force to move the patient's teeth in small increments from their original positions to planned positions. CREOKORREKT Aligners are intended as an alternative to conventional wire and bracket orthodontic technology and fixed appliances for the treatment of patients with tooth malocclusion. A dentist determines a treatment plan based on the assessment of the patient's teeth and prescribes the CREOKORREKT. To obtain the dimensions and details of a patient's dentition, a dentist takes intraoral scanning or a physical impression (PVS Impression) and sends them with a prescription to CreoDent Prosthetics LTD. With PVS impressions, physical models are fabricated and scanned. Scanned data are directly imported into dental design software for planning. CreoDent Prosthetics LTD designs the process of treatment by creating a series of the sequential model intended to gradually move the patient's teeth to the desired position in accordance with the dentist's prescription utilizing the dental design software. The doctor reviews and approves the treatment scheme. CreoDent Prosthetics LTD fabricates a series of models for thermoforming.
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    K Number
    K113738
    Device Name
    CREODENT SOLIDEX CUSTOM ABUTMENT
    Date Cleared
    2013-09-17

    (637 days)

    Product Code
    Regulation Number
    872.3630
    Why did this record match?
    Applicant Name (Manufacturer) :

    CREODENT PROSTHETICS LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The CreoDent Solidex® Customized Abutment is intended for use with an endosseous implant to support a prosthetic device in patients who are partially or completely endentulous. The device can be used for single or multiple-unit restorations. The prosthesis can be cemented or screw retained to the abutment. An abutment screw is used to secure the abutment to the endosseous implant. The CreoDent Solidex® Customized Abutment is compatible with the following: - Nobel Replace™ TiUnite Endosseous 3.5mm, 4.3mm, and 5.0mm diameter Implants . - Nobel Active™ Internal Connection 3.5mm and 4.3mm diameter Implants . - Zimmer Screw-Vent 3.7mm, 4.7mm ; Zimmer Tapered Screw-Vent , 3.7mm, 4.7mm and . 6.0mm diameter implants
    Device Description
    The Solidex® Customized Abutment is made of CP TI Gr4 grade unalloyed titanium for surgical implants applications (meets ASTM Standard F67/Gr 04-06) and is designed to be screw retained for use with endosseous dental implants to provide support for a prosthetic restoration. These abutments are indicated for cement or screw retained restorations. Solidex® Customized Abutments are compatible with: - . Nobel Replace™ TiUnite Endosseous 3.5mm, 4.3mm, and 5.0mm diameter Implants (510K#023113) - . Nobel Active™ Internal Connection 3.5mm and 4.3mm diameter Implants (510K#071370) - Zimmer Screw-Vent 3.7mm, 4.7mm; Zimmer Tapered Screw-Vent 3.7mm, 4.7mm and 6.0mm diameter Implants (510K#013227) The design of subject device is customized to the requirements of each patient as may be specified by the prescribing dentist.
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