# K131258: Saturn Dental Implant

- Pathway: 510(k) (Traditional)
- Applicant: Cortex Dental Implants Industries, Ltd.
- Decided: Mar 17, 2014 after 319 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: 10 generations back to K894595 (1990). 42 ancestors in all.
No later device cites it as a predicate yet.
0 of 43 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121131: BL, 04.1 MM RC, Slactive 8MM, Tizr and 10MM, 12, 14MM, Straumann USA (2012) Summary page 1.
- (no number) Nobel Active: named in the summary without a submission number

## Indications for use
The SATURN Dental Implant System is intended for surgical placement in the maxillary and/or the mandibular arch, to support crowns, bridges, or over dentures, in edentulous; or partially edentulous; patients. It is intended to provide support for prosthetic devices, such as artificial teeth, and to restore the patients chewing function. The System is intended to be used in either single tooth or multiple teeth restoration for immediate loading after extraction when good primary stability is achieved and with appropriate occlusal loading . The procedure can be accomplished in a one-stage or two-stage surgical operation.

Source page: https://510kreport.com/device/K131258
Methodology: https://510kreport.com/methodology