# K231127: S.I.N. Dental Implant System

- Pathway: 510(k) (Traditional)
- Applicant: S.I.N. - Sistema DE Implante Nacional S.A.
- Decided: Dec 7, 2023 after 231 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: 14 generations back to K894595 (1990). 171 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 174 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K203725: S.I.N. Dental Implant System, S.I.N. - Sistema DE Implante Nacional S.A. (2021) Summary page 5.

## Most influential descendants
- K251129: S.I.N. Tapered Pro Conical Zygoma Implant System (2025), 0 descendants of its own
- K240609: S.I.N. Dental Implant System (2024), 0 descendants of its own

## 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/K231127
Methodology: https://510kreport.com/methodology