# K181953: SDS1.2 dental implant

- Pathway: 510(k) (Traditional)
- Applicant: Sds Swiss Dental Solutions AG
- Decided: Nov 20, 2019 after 485 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 K944964 (1995). 92 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 94 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172668: W Zirconia Implants, Tav Medical, Ltd. (2018). Cleared while this submission was under review Summary page 4.

## Most influential descendants
- K190406: SDS2.2 dental implant (2020), 0 descendants of its own

## Indications for use
SDS1.2 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. SDS1.2_33xx implants are recommended as single-tooth implant for upper lateral and lower incisors for fixed prosthetic restorations only. SDS1.2 healing caps-disc, SDS1.2 temporary caps and SDS1.2 standard screws are industrially manufactured prosthetic components. They are connected to the SDS1.2 dental implant and enable the production/ fixation of long-term temporary restorations or protect the implant during healing phase for up to 180 days.

Source page: https://510kreport.com/device/K181953
Methodology: https://510kreport.com/methodology