# K222231: S.I.N. Dental Implant System

- Pathway: 510(k) (Traditional)
- Applicant: S.I.N. - Sistema DE Implante Nacional S.A.
- Decided: Oct 27, 2022 after 94 days
- Product code: DZE (Implant, Endosseous, Root-Form)
- Device class: 2
- Regulation: 21 CFR 872.3640
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 19 generations back to K960026 (1996). 382 ancestors in all.
4 later devices descend from it; 4 cite it directly.
0 of 387 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K211921: S.I.N. Dental Implant System, S.I.N. - Sistema DE Implante Nacional S.A. (2021) Summary page 4.
- K203725: S.I.N. Dental Implant System, S.I.N. - Sistema DE Implante Nacional S.A. (2021) Summary page 4.
- K050406: Nobelspeedy Implants, Nobel Biocare AB (2005) 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
- K221453: S.I.N. Dental Implant System (2022), 1 descendant of its own
- K251262: S.I.N. Dental Implant System (2025), 0 descendants of its own
- K251046: S.I.N. Dental Implant System (2025), 0 descendants of its own
- K230069: S.I.N. Dental Implant System (2023), 0 descendants of its own

## Recalls of this device
- Sep 1, 2024 · Class II · Z-0920-2025: Dental implant box incorrectly labels the diameter as 4,5 X 18,0 mm, but the internal label correctly labels the diameter as 4,0 X 18,0 mm; if the dentist drills the bone with the larger diameter stat

## 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 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.

Source page: https://510kreport.com/device/K222231
Methodology: https://510kreport.com/methodology