# K200992: S.I.N. Dental Implant System

- Pathway: 510(k) (Traditional)
- Applicant: S.I.N. - Sistema DE Implante Nacional S.A.
- Decided: Nov 17, 2020 after 216 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: 13 generations back to K894595 (1990). 245 ancestors in all.
7 later devices descend from it; 3 cite it directly.
0 of 253 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170392: S.I.N. Implant System, S.I.N. – Sistema DE Implante Nacional S.A. (2017) Summary page 4.
- K170398: S.I.N. Dental Implant System, S.I.N. – Sistema DE Implante Nacional S.A. (2017) Summary page 4.
- K163194: Neodent Implant System - GM Line, Jjgc Industria E Comercio DE Materiais Dentarios S.A. (2017) Summary page 4.
- K101945: Neodent Implant System, Jjgc Industria E Comercio DE Materiais Dentarios S (2011) Summary page 4.
- K961736: 17 Angulated Abutment, Nobelpharma USA, Inc. (1996) Summary page 5.
- K905434: Angulated Abutment, Complete,Titanium Sdca 102, Nobelpharma USA, Inc. (1992) Summary page 5.
- K161416: Multi-unit Abutment Plus, Nobel Biocare AB (2017) Summary page 5.
- K052600: Zimmer Dental Hex-Lock Prepared Abutment (Straight & Angled), Zimmer Dental, Inc. (2005) Summary page 5.
- K110955: Anyridge Internal Implant System, Megagen Co., Ltd. (2011) 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.

Source page: https://510kreport.com/device/K200992
Methodology: https://510kreport.com/methodology