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510(k) Data Aggregation
K Number
K203240Device Name
AccelX Abutments
Manufacturer
Integrated Dental Systems LLC
Date Cleared
2021-04-27
(175 days)
Product Code
NHA
Regulation Number
872.3630Why 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.
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