# K131097: LEGACY3 6MM Length Implants

- Pathway: 510(k) (Traditional)
- Applicant: Implant Direct Sybron Manufacturing, LLC
- Decided: Aug 22, 2013 after 126 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). 26 ancestors in all.
No later device cites it as a predicate yet.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061319: Spectra System, Implant Direct, LLC (2006) Summary page 1.
- K073033: Legacy Dental Implants, Implant Direct, LLC (2007) Summary page 1.
- K090234: Spectra System Dental Implants 2008, Implant Direct, LLC (2009) Summary page 1.
- K081396: Swissplant Dental Implant System, Implant Direct, LLC (2009) Summary page 1.
- K092035: Bicon Implants with a 2.5MM Internal Connection, Bicon, LLC (2009) Summary page 1.
- K073368: 5.0 X 5.0MM Dental Implant and 6.0 X 5.0 Dental Implant, Bicon, LLC (2008) Summary page 1.
- K030007: Iti Dental Implant System, Straumann USA (2003) Summary page 1.

## Indications for use
Legacy3 6mm Length implants consist of two-piece implants for one-stage or two-stage surgical procedures. These implants are intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or intermediate abutment support for fixed bridgework. Implants can be indicated for immediate loading when good primary stability has been achieved and with appropriate occlusal loading.

Source page: https://510kreport.com/device/K131097
Methodology: https://510kreport.com/methodology