# K082573: Sargon Non-Expandable Dental Implant

- Pathway: 510(k) (Traditional)
- Applicant: Sargon Ent., Inc.
- Decided: Jul 21, 2010 after 684 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: 7 generations back to K894595 (1990). 37 ancestors in all.
No later device cites it as a predicate yet.
0 of 38 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012757: Iti Dental Implant System, Straumann USA (2001) Summary page 1.
- K003271: Modification to Iti Dental Implant System, Institut Straumann AG (2001) Summary page 1.
- K033984: Straumann Dental Implant System, Institut Straumann AG (2004) Summary page 1.
- K930071: Sargon Cylindro-Blade Implant, Sargon Ent., Inc. (1994) Summary page 1.
- K961005: Sargon Immediate Load Implant, Graham & James (1996) Summary page 1.
- K981141: Sargon Immediate Load Implant, Model D, Sargon Ent., Inc. (1999) Summary page 1.

## Indications for use
The Sargon Non-Expandable Dental Implant is indicated for immediate placement or delayed placement in the bone of the upper or lower jaw to support prosthetic devices such as artificial teeth, crowns, bridges or overdentures in partially or fully edentulous patients and to restore the patient's chewing function. This device is not indicated for immediate loading.

Source page: https://510kreport.com/device/K082573
Methodology: https://510kreport.com/methodology