# K203725: S.I.N. Dental Implant System

- Pathway: 510(k) (Traditional)
- Applicant: S.I.N. - Sistema DE Implante Nacional S.A.
- Decided: Jun 23, 2021 after 184 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: 13 generations back to K894595 (1990). 170 ancestors in all.
8 later devices descend from it; 2 cite it directly.
0 of 179 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170398: S.I.N. Dental Implant System, S.I.N. – Sistema DE Implante Nacional S.A. (2017) Summary page 4.

## Most influential descendants
- K222231: S.I.N. Dental Implant System (2022), 4 descendants of its own
- K231127: S.I.N. Dental Implant System (2023), 2 descendants of its own
- K221453: S.I.N. Dental Implant System (2022), 1 descendant of its own
- K251129: S.I.N. Tapered Pro Conical Zygoma Implant System (2025), 0 descendants of its own
- K251262: S.I.N. Dental Implant System (2025), 0 descendants of its own

## Indications for use
For Strong SW HE Implants S.I.N. Dental Implant System is intended for placement in the maxillary or mandibular arch to provide support for single-unit or multi-unit restorations. When a one-stage surgical approach is applied, the S.I.N. Dental Implant System is intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading. S.I.N. Dental Implant System implants with lengths of 18, 20, 22, or 24 mm when placed in the maxilla are only indicated for multiple unit restorations in splinted applications that utilize at least two implants. For Zygomatic Implants and Abutments 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/K203725
Methodology: https://510kreport.com/methodology