# K230069: S.I.N. Dental Implant System

- Pathway: 510(k) (Traditional)
- Applicant: S.I.N. – Sistema DE Implante Nacional S.A.
- Decided: Apr 6, 2023 after 86 days
- Product code: NHA (Abutment, Implant, Dental, Endosseous)
- Device class: 2
- Regulation: 21 CFR 872.3630
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 21 generations back to K960026 (1996). 384 ancestors in all.
No later device cites it as a predicate yet.
0 of 385 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K193096: S.I.N. Dental Implant System, S.I.N. - Sistema DE Implante Nacional S.A. (2020) Summary page 4.
- K221453: S.I.N. Dental Implant System, S.I.N. – Sistema DE Implante Nacional S.A. (2022) Summary page 4.
- K222231: S.I.N. Dental Implant System, S.I.N. - Sistema DE Implante Nacional S.A. (2022) Summary page 4.
- K211921: S.I.N. Dental Implant System, S.I.N. - Sistema DE Implante Nacional S.A. (2021) Summary page 5.
- K200992: S.I.N. Dental Implant System, S.I.N. - Sistema DE Implante Nacional S.A. (2020) Summary page 5.
- K170392: S.I.N. Implant System, S.I.N. – Sistema DE Implante Nacional S.A. (2017) 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 Pre-Milled CAD-CAM Abutments are to be sent to a S.I.N.-validated milling center for manufacture.

Source page: https://510kreport.com/device/K230069
Methodology: https://510kreport.com/methodology