# K011879: 3A Dental Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Osseco Biosource, Ltd.
- Decided: Aug 27, 2002 after 438 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: 3 generations back to K894595 (1990). 11 ancestors in all.
223 later devices descend from it; 1 cites it directly.
0 of 235 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993595: Nobel Biocare's Modified Surface Implant (Intended for Immediate Loading Upon Placement), Nobel Biocare Uas, Inc. (2000) Summary page 2.
- K002374: Iti Dental Implant System Monotype Implant, Straumann USA (2000)

## Most influential descendants
- K051576: Avana Dental Implant System (2005), 222 descendants of its own
- K062051: SS System (2006), 211 descendants of its own
- K063861: GS System (2007), 202 descendants of its own
- K062030: US System (2006), 183 descendants of its own
- K073247: US/SS/GS System (2008), 141 descendants of its own

## Indications for use
The 3A Dental Implant System is intended for single or multiple surgical implantation (with or without tissue integration) in the maxillary and or mandibular arches for the purpose of providing prosthetic support for dental restorations in partially or totally edentulous individuals. May be used for single tooth restoration.

Source page: https://510kreport.com/device/K011879
Methodology: https://510kreport.com/methodology