# K061797: SM Implant Systems

- Pathway: 510(k) (Traditional)
- Applicant: Dio Department Dsi, Inc.
- Decided: Sep 1, 2006 after 67 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
No predicates in its family tree.
31 later devices descend from it; 4 cite it directly.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K012087: Cordis Palmaz Genesis Transhepatic Biliary Stent, Cordis Corp. (2001). Our reading of the summary gave K012087, FDA’s number for Cordis Palmaz Genesis Transhepatic Biliary Stent (Cordis Corp.). Its FDA name has none of the distinctive words the summary uses for the device it names, “ANKYLOS® DENTAL IMPLANT SYSTEM”. Kept off the family tree.

## Most influential descendants
- K073486: Dentis Dental Implant System (2008), 25 descendants of its own
- K150344: Dentis Dental Implant System (2015), 20 descendants of its own
- K153639: OneQ-SL s-Clean Implant System (2016), 14 descendants of its own
- K171027: Dentis Dental Implant System (2017), 5 descendants of its own
- K192688: s-Clean SQ-SL Implant System Regular (2020), 3 descendants of its own

## Indications for use
The SM® Implant System is an endosseous dental implant is indicated for surgical placement in the upper and lower jaw arches, to provide a root form means for single or multiple units' prosthetic appliance attachment to restore a patient's chewing function. Implants can be placed with a conventional two stage surgical process with an option for transmucosal healing or they can be placed in a single stage surgical process for immediate loading. Immediate loading is restricted to the anterior mandible, based on four splinted interforminal placed implants, and not indicated for single, unsplinted implants.

Source page: https://510kreport.com/device/K061797
Methodology: https://510kreport.com/methodology