# K203240: AccelX Abutments

- Pathway: 510(k) (Traditional)
- Applicant: Integrated Dental Systems, LLC
- Decided: Apr 27, 2021 after 175 days
- Product code: NHA (Abutment, Implant, Dental, Endosseous)
- Device class: 2
- Regulation: 21 CFR 872.3630
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 18 generations back to K960026 (1996). 369 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 372 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191986: DESS Dental Smart Solutions, Terrats Medical SL (2019) Summary page 4.
- K123988: Anyonetm Internal Implant System, Megagen Implant Co., Ltd. (2013) Summary page 4.
- K182448: AnyRidge Octa 1 Implant System, Megagen Implant Co., Ltd. (2019) Summary page 4.
- K140091: Xpeed Anyridge Internal Implant Sysyem, Megagen Implant Co., Ltd. (2014) Summary page 4.
- K140728: Mpi - Molecular Precision Implant, Cpi - Cylindrical Precision Implant, Opi - One Piece Implant, Dental Abutments and PR, Ditron Precision, Ltd. (2014) Summary page 4.

## Most influential descendants
- K252585: ZENEX Implant System_R-System (2026), 1 descendant of its own
- K253334: ZENEX Implant System_Short (R-System) (2026), 0 descendants of its own

## Indications for 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 4.0 3.5 Implant System 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

Source page: https://510kreport.com/device/K203240
Methodology: https://510kreport.com/methodology