# K133327: Saturno (TM) Overdenture Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Zest Anchors, LLC
- Decided: Jun 25, 2014 after 239 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: 11 generations back to K960026 (1996). 89 ancestors in all.
No later device cites it as a predicate yet.
0 of 90 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120198: Locator Overdenture Implant System, Zest Anchors, LLC (2012) Summary page 2.
- K031106: Imtec Sendax Mdi and Mdi Plus Endosseous Implant, Models OB-XX, SH-XX, Mob-22, MSH-XX, Imtec Corp. (2003) Summary page 2.
- K081653: Mdi Mii One-Piece Implant, 2.9MM, Imtec Corp. (2008) Summary page 2.

## Cited in the summary but kept off the family tree
- K070601: Mini Drive-Lock Dental Implant System, Intra-Lock International (2007). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Indications for use
The SATURNO™ Overdenture Implant System is designed to retain overdentures or partial dentures in the mandible or maxilla. The SODI is used to restore masticatory function for the patient and may be suitable for immediate function if sufficient primary stability of the implant is achieved at the time of placement.

Source page: https://510kreport.com/device/K133327
Methodology: https://510kreport.com/methodology