# K981141: Sargon Immediate Load Implant, Model D

- Pathway: 510(k) (Traditional)
- Applicant: Sargon Ent., Inc.
- Decided: Jun 23, 1999 after 450 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: 1 generation back to K930071 (1994). 2 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K930071: Sargon Cylindro-Blade Implant, Sargon Ent., Inc. (1994) Summary page 1.
- K961005: Sargon Immediate Load Implant, Graham & James (1996) Summary page 1.

## Most influential descendants
- K152188: QUAD Dental Implants and Prostheses (2016), 1 descendant of its own
- K180859: PYRAMIDION Dental Implants and Prostheses (2018), 0 descendants of its own
- K082573: Sargon Non-Expandable Dental Implant (2010), 0 descendants of its own

## Indications for use
For immediate load use, without an abutment, in either partially or fully edentulous mandibles and maxillae, for fixed or detachable prosthesis and for use in support of free-standing restorations with or without the involvement of adjacent dentition.

Source page: https://510kreport.com/device/K981141
Methodology: https://510kreport.com/methodology