Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K203240
    Device Name
    AccelX Abutments
    Manufacturer
    Integrated Dental Systems LLC
    Date Cleared
    2021-04-27

    (175 days)

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

    Integrated Dental Systems LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    AccelX™ Abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support for single-unit or multi-unit prosthetic restorations. All digitally designed abutments for use with AccelX™ CAD-CAM Abutments are intended to be sent to an Integrated Dental Systems validated milling center for manufacture. AccelX™ Abutments are compatible with MegaGen AnyRidge Internal Implant System components as listed below. | Implant System Compatibility | Implant Body Diameter, mm | Implant Platform, mm | |---------------------------------------------|---------------------------|----------------------| | MegaGen AnyRidge Internal<br>Implant System | 4.0 | 3.5 | | | 4.4 | 3.5 | | | 4.9 | 3.5 | | | 5.4 | 3.5 | | | 5.9 | 3.5 | | | 6.4 | 5.0 | | | 6.9 | 5.0 | | | 7.4 | 5.0 | | | 7.9 | 5.0 | | 8.4 | 5.0 | |
    Device Description
    AccelX™ Abutments comprises conventional and CAD-CAM abutments, abutment screws, and other associated components compatible with MegaGen AnyRidge Internal Implant System. AccelX™ conventional abutments and prosthetic components include Cover Screws. Healing Abutments. Temporary Abutments, Prepable Straight Abutments, Angled Abutments, Castable Base Abutments, and Multi-Unit Abutments. All conventional abutments and prosthetic components are manufactured from Ti-Al-4V alloy conforming to ASTM F136 except the Castable Base Abutments that are manufactured from Co-Cr-Mo alloy conforming to ASTM F1537. AccelX™ CAD-CAM abutments include Titanium Base Abutments for use with a zirconia coping, and Titanium Blank Abutments to be milled to a final one-piece abutment. Titanium Base Abutments are twopiece abutments composed of the titanium base component and a zirconia top-half, which comprises the final abutment once the two components are cemented together using CemPlant Implant Cement. The Titanium Base Abutments and Titanium Blank Abutments are manufactured from Ti-Al-4V alloy conforming to ASTM F136. The zirconia copings for the Titanium Base Abutments will be manufactured from zirconia conforming to ISO 13356. All digitally designed abutments for use with AccelX™ CAD-CAM abutments are intended to be sent to an Integrated Dental Systems validated milling center for manufacture.
    Ask a Question

    Page 1 of 1