# K251046: S.I.N. Dental Implant System

- Pathway: 510(k) (Traditional)
- Applicant: S.I.N. Implant System Ltda
- Decided: Aug 13, 2025 after 132 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). 385 ancestors in all.
No later device cites it as a predicate yet.
0 of 386 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170392: S.I.N. Implant System, S.I.N. – Sistema DE Implante Nacional S.A. (2017) Summary page 5.
- K222231: S.I.N. Dental Implant System, S.I.N. - Sistema DE Implante Nacional S.A. (2022) Summary page 5.
- K201225: Neodent Implant System - GM Helix Implants 7.0, Jjgc Industria E Comercio DE Materiais Dentarios S.A. (2020) Summary page 5.
- K150182: Neodent Implant System- CM Drive Implants, Jjgc Industria E Comercio DE Materiais Dentarios S (2015) 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 implants are 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 24mm may be tilted up to 30º. When used in the mandible or maxilla with implants with lengths of 18, 20, 22 or 24 mm at an angulation of 30º, a minimum of four implants must be used and must be splinted. When placed in the maxilla with lengths of 18, 20, 22 or 24 mm at angulations between 0º and less than 30º, the S.I.N. Dental Implant System implants are only indicated for multiple unit restoration in splinted applications that utilize at least two implants.

Source page: https://510kreport.com/device/K251046
Methodology: https://510kreport.com/methodology