# K253493: Dentis SQ-SL AXEL Fixture

- Pathway: 510(k) (Traditional)
- Applicant: Dentis Co., Ltd.
- Decided: Mar 4, 2026 after 128 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). 99 ancestors in all.
No later device cites it as a predicate yet.
0 of 100 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192688: s-Clean SQ-SL Implant System Regular, Dentis Co., Ltd. (2020) Summary page 5.

## Indications for use
Dentis SQ -SL AXEL Fixture 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/K253493
Methodology: https://510kreport.com/methodology