# K251262: S.I.N. Dental Implant System

- Pathway: 510(k) (Traditional)
- Applicant: S.I.N. Implant System Ltda
- Decided: Sep 26, 2025 after 156 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: 20 generations back to K960026 (1996). 383 ancestors in all.
No later device cites it as a predicate yet.
0 of 384 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222231: S.I.N. Dental Implant System, S.I.N. - Sistema DE Implante Nacional S.A. (2022) Summary page 5.

## Indications for use
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. All digitally-designed custom abutments for use with Interface CAD-CAM abutments are to be sent to a S.I.N.- validated milling center for manufacture. The Abutment Mini Angled Morse 45º is intended for use with the S.I.N. Dental Implant System Zygomatic implants. 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/K251262
Methodology: https://510kreport.com/methodology