# K242261: Accelx Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Biotech Dental, LLC
- Decided: Nov 6, 2024 after 98 days
- Product code: DZE (Implant, Endosseous, Root-Form)
- Device class: 2
- Regulation: 21 CFR 872.3640
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K944964 (1995). 72 ancestors in all.
No later device cites it as a predicate yet.
0 of 73 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123870: Xpeed Anyridge Internal Implant System, Megagen Implant Co., Ltd. (2013) Summary page 6.

## Indications for use
Accelx Implant System implants are indicated for use in partially or fully edentulous patients to support maxillary and mandibular single-unit, multiple-unit, and overdenture dental restorations. Accelx Implant System implants are indicated for immediate loading when good primary stability is achieved and with appropriate occlusal loading. Implant diameters larger than 6.0 mm are dedicated for the molar region and are indicated for delayed loading. Accelx Implant System implants are compatible with Accelx Implant System abutments. Accelx Implant System implants are compatible with MegaGen AnyRidge Internal Implant System titanium abutments as listed below. Accelx Implant System cover screws are compatible with MegaGen AnyRidge Internal Implant System implant components as listed below.

Source page: https://510kreport.com/device/K242261
Methodology: https://510kreport.com/methodology