# K170398: S.I.N. Dental Implant System

- Pathway: 510(k) (Traditional)
- Applicant: S.I.N. – Sistema DE Implante Nacional S.A.
- Decided: Nov 21, 2017 after 285 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). 169 ancestors in all.
17 later devices descend from it; 6 cite it directly.
0 of 187 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 5.
- K072570: Nobelactive Multi Unit Abutment, Nobel Biocare AB (2007) Summary page 5.
- K072363: Nanotite Prevail,Certain,Parellel Walled,Tapered,External Hex, Biomet 3i, Inc. (2008) Summary page 5.
- K092035: Bicon Implants with a 2.5MM Internal Connection, Bicon, LLC (2009) Summary page 5.
- K101945: Neodent Implant System, Jjgc Industria E Comercio DE Materiais Dentarios S (2011) Summary page 5.

## Most influential descendants
- 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
- 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

## 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. Revolution Compact with a 6 mm length is intended for delayed loading only.

Source page: https://510kreport.com/device/K170398
Methodology: https://510kreport.com/methodology