# K240977: DenQ Sub SLA Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Denq
- Decided: Sep 13, 2024 after 156 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: 15 generations back to K894595 (1990). 78 ancestors in all.
No later device cites it as a predicate yet.
0 of 79 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222707: IH Implant System, Sewonmedix, Inc. (2023) Summary page 5.

## Indications for use
The DenQ Sub SLA Implant System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. This system is dedicated for one and two stage surgical procedures. This system is intended for delayed loading.

Source page: https://510kreport.com/device/K240977
Methodology: https://510kreport.com/methodology