# K240609: S.I.N. Dental Implant System

- Pathway: 510(k) (Traditional)
- Applicant: S.I.N. - Sistema DE Implante Nacional S.A.
- Decided: Jul 17, 2024 after 135 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). 172 ancestors in all.
No later device cites it as a predicate yet.
0 of 173 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K231127: S.I.N. Dental Implant System, S.I.N. - Sistema DE Implante Nacional S.A. (2023) Summary page 5.

## Indications for use
S. I. N. Dental Implant System Zygomatic implants are intended for placement in the maxillary arch to provide support for fixed or removable dental prostheses in patients with partially or fully edentulous maxillae. When a one-stage surgical approach is applied, the S. I. N. Dental Implant System Zygomatic implants are intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

Source page: https://510kreport.com/device/K240609
Methodology: https://510kreport.com/methodology