# K051859: Sistema DE Implante Nacional (S.I.N.); Dental Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Sin Sistema DE Implante Nacional Ltda
- Decided: Sep 23, 2005 after 77 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
No predicates in its family tree.
22 later devices descend from it; 3 cite it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K170398: S.I.N. Dental Implant System (2017), 17 descendants of its own
- K170392: S.I.N. Implant System (2017), 16 descendants of its own
- K203725: S.I.N. Dental Implant System (2021), 8 descendants of its own
- K193096: S.I.N. Dental Implant System (2020), 8 descendants of its own
- K200992: S.I.N. Dental Implant System (2020), 7 descendants of its own

## Indications for use
The Sistema de Implante Nacional Dental Implant System is intended to be surgically placed in the bone of the maxillary and/or mandibular arch to provide support for crowns, bridges or overdentures. Implants may be placed immediately after tooth extraction or following bone healing. Restorations supported by two or more Sistema de'lmplante Nacional implants may be loaded immediately after implant placement if primary implant stability has been achieved.

Source page: https://510kreport.com/device/K051859
Methodology: https://510kreport.com/methodology