# K170392: S.I.N. Implant System

- Pathway: 510(k) (Traditional)
- Applicant: S.I.N. – Sistema DE Implante Nacional S.A.
- Decided: Dec 1, 2017 after 296 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: 12 generations back to K894595 (1990). 197 ancestors in all.
16 later devices descend from it; 10 cite it directly.
0 of 214 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051859: Sistema DE Implante Nacional (S.I.N.); Dental Implant System, Sin Sistema DE Implante Nacional Ltda (2005) Summary page 4.
- K120414: Osseospeed Plus, Astra Tech AB (2012) Summary page 4.
- K072570: Nobelactive Multi Unit Abutment, Nobel Biocare AB (2007) Summary page 4.
- K081653: Mdi Mii One-Piece Implant, 2.9MM, Imtec Corp. (2008) Summary page 4.
- K101225: Promimic Dental Implant, 3.75 MM, Length 8.5 MM Model 03-1001, Promimic Dental Implant, 3.75 MM, Length 10 MM Model 03-1, Promimic AB (2011) Summary page 4.
- K092035: Bicon Implants with a 2.5MM Internal Connection, Bicon, LLC (2009) Summary page 4.

## Most influential descendants
- 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
- 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
- K183024: Implacil Implant System (2020), 2 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. Implants with lengths less than 7 mm are intended for delayed loading only.

Source page: https://510kreport.com/device/K170392
Methodology: https://510kreport.com/methodology