Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K222984
    Device Name
    BioClean Implant Restorative System
    Date Cleared
    2022-12-29

    (92 days)

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

    BioClean Dental, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The BioClean Implant Restorative System is designed to support fixed/detachable partial or full arch restorations on endosseous dental implants in the maxilla for the purpose of restoring masticatory function. It is used in fixed/detachable restorations that can be attached with a friction-based engagement system. All digitally designed copings for use with the BioClean Implant Restorative System are to BioClean Dental or a validated milling center for manufacture. The BioClean Implant Restorative System is compatible with the following: | BioClean Implant Restorative System Compatibility | | |--------------------------------------------------------------------------------------------------------|--------------------------------------------------| | Implant Components | Configurations | | Bone Level Straumann® Multi-Unit<br>Abutments NC/RC<br>Straumann Multi-Unit Abutment Occlusal<br>Screw | 4.6mm Platform Diameter, All Gingival<br>Heights |
    Device Description
    The BioClean Implant Restorative System provides rigid connection of partial and full arch restorations to endosseous dental implants in the mandible or maxilla. The BioClean Implant Restorative System consists of copings, denture housings, and retention inserts that are intended to allow for a fixed/detachable prosthesis to be connected to OEM multiunit abutments for stable attachment of the prosthesis to endosseous dental implants. All BioClean copings are made of titanium alloy and have the same coronal ridge retention design that attaches to the prosthesis component by a friction-based engagement system. The subject device coping connects to the OEM multi-unit abutment and is specific to each compatible abutment system and diameter. The subject device copings are offered with angulation from 0° to 9° in 0.5° increments and also in a patient specific version in which the dental laboratory technician designs the coping in CAD software and then sends the design to BioClean Dental or a validated milling center for fabrication from a coping blank. By use of a combination of pre-manufactured and patientspecific versions of the copings, a multi-unit prosthesis can be created in which the copings are parallel.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1