# K051576: Avana Dental Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Osstem Co., Ltd.
- Decided: Sep 1, 2005 after 79 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: 4 generations back to K894595 (1990). 14 ancestors in all.
222 later devices descend from it; 4 cite it directly.
0 of 237 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003226: The Lifecore Stage-1 Single Stage RBM Dental Implant System, Lifecore Biomedical, Inc. (2001) Summary page 1.
- K011879: 3A Dental Implant System, Osseco Biosource, Ltd. (2002) Summary page 1.
- K002188: Swissplus Implant System, Model SPWB 8,10,12,14/OPH20/SMPR, SPB 8,10,12,14/OP3.5D/Opar,Opb 8,10,12,14/OP2.3D/OP2.8D,, Core-Vent Corp. (2000)

## Most influential descendants
- 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
- K081575: HU/HS/HG Prosthetic System (2008), 129 descendants of its own

## Indications for use
AVANA Dental Implant Systems are designed for use in dental implant surgery. A successfully osseointegrated implant will achieve a firm and direct connection between the living bone and the surface of the titanium fixture when surgically implanted under controlled conditions, as per well known clinical studies. They are intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cement retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework.

Source page: https://510kreport.com/device/K051576
Methodology: https://510kreport.com/methodology