# K193096: S.I.N. Dental Implant System

- Pathway: 510(k) (Traditional)
- Applicant: S.I.N. - Sistema DE Implante Nacional S.A.
- Decided: May 14, 2020 after 189 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: 17 generations back to K960026 (1996). 364 ancestors in all.
8 later devices descend from it; 5 cite it directly.
0 of 373 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.
- K170392: S.I.N. Implant System, S.I.N. – Sistema DE Implante Nacional S.A. (2017) Summary page 5.
- K051859: Sistema DE Implante Nacional (S.I.N.); Dental Implant System, Sin Sistema DE Implante Nacional Ltda (2005) Summary page 5.
- K183518: Preat Abutments, Preat Corporation (2019) Summary page 5.

## Most influential descendants
- K211921: S.I.N. Dental Implant System (2021), 5 descendants of its own
- K222231: S.I.N. Dental Implant System (2022), 4 descendants of its own
- K221453: S.I.N. Dental Implant System (2022), 1 descendant of its own
- K252266: S.I.N. Dental Implant System (2025), 0 descendants of its own
- K251262: S.I.N. Dental Implant System (2025), 0 descendants of its own

## 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.

Source page: https://510kreport.com/device/K193096
Methodology: https://510kreport.com/methodology