# K251129: S.I.N. Tapered Pro Conical Zygoma Implant System

- Pathway: 510(k) (Traditional)
- Applicant: S.I.N. Implant System Ltda
- Decided: Nov 7, 2025 after 210 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
Pro Zygoma dental 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. The Pro Zygoma dental implants may be used with single-stage or two-stage procedures and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading.

Source page: https://510kreport.com/device/K251129
Methodology: https://510kreport.com/methodology