# K221453: S.I.N. Dental Implant System

- Pathway: 510(k) (Traditional)
- Applicant: S.I.N. – Sistema DE Implante Nacional S.A.
- Decided: Dec 15, 2022 after 210 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: 20 generations back to K960026 (1996). 383 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 385 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222231: S.I.N. Dental Implant System, S.I.N. - Sistema DE Implante Nacional S.A. (2022). Cleared while this submission was under review Summary page 4.
- K211921: S.I.N. Dental Implant System, S.I.N. - Sistema DE Implante Nacional S.A. (2021) Summary page 4.
- K193096: S.I.N. Dental Implant System, S.I.N. - Sistema DE Implante Nacional S.A. (2020) Summary page 4.
- K170392: S.I.N. Implant System, S.I.N. – Sistema DE Implante Nacional S.A. (2017) Summary page 4.

## Most influential descendants
- K230069: S.I.N. Dental Implant System (2023), 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. S.I.N. Dental Implant System implants with lengths of 18, 20, 22, or 24 mm may be tilted up to 30°. When used in the mandible or maxilla with implants with lengths of 18, 20, 22, or 24 mm at an angulation of 30°, a minimum of four implants must be used and must be splinted. When placed in the maxilla with lengths of 18, 20, 22, or 24 mm at angulations between 0° and less than 30°, the S.I.N. Dental Implant System implants are only indicated for multiple unit restorations in splinted applications that utilize at least two implants. 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/K221453
Methodology: https://510kreport.com/methodology