# K190406: SDS2.2 dental implant

- Pathway: 510(k) (Traditional)
- Applicant: Sds Swiss Dental Solutions AG
- Decided: Feb 20, 2020 after 364 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 K944964 (1995). 93 ancestors in all.
No later device cites it as a predicate yet.
0 of 94 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181953: SDS1.2 dental implant, Sds Swiss Dental Solutions AG (2019). Cleared while this submission was under review Summary page 4.

## Indications for use
SDS2.2 dental implants are intended as artificial replacements to be placed in the human upper or lower jaw to provide anchor points for the prosthetic restoration. They are indicated for transgingival healing. The implants are indicated for immediate loading when good primary stability is achieved and with appropriate occlusal loading. SDS2.2 standard implant posts and SDS2.2 standard screws are industrially manufactured prosthetic components. They are connected to the SDS2.2 dental implant and enable the fixation of prosthetic restorations.

Source page: https://510kreport.com/device/K190406
Methodology: https://510kreport.com/methodology