# K073033: Legacy Dental Implants

- Pathway: 510(k) (Traditional)
- Applicant: Implant Direct, LLC
- Decided: Dec 10, 2007 after 45 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 K013277 (2001). 2 ancestors in all.
25 later devices descend from it; 4 cite it directly.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013277: Astralis 7, Model 557545, Ivoclar Vivadent, Inc. (2001) Summary page 1.
- K061319: Spectra System, Implant Direct, LLC (2006) Summary page 1.

## Most influential descendants
- K090234: Spectra System Dental Implants 2008 (2009), 22 descendants of its own
- K130572: Interactive/ SWISHPLUS2 Implant System (2013), 10 descendants of its own
- K143011: 2014 InterActive/SwishActive System (2015), 8 descendants of its own
- K181359: InterActive SMARTBase Abutments (2018), 6 descendants of its own
- K193084: TIB Abutment System (2020), 3 descendants of its own

## Indications for use
The Legacy Dental Implant with HA coating is a dental implant fixture that is a part of a two-piece implant system. The Legacy implants are intended for use in the mandible and maxilla, in support of single or multiple-unit cement or screw receiving fixed restorations and for retention and support of overdentures. The implants are intended for immediate placement and function for support of single tooth and/or multiple tooth restorations, recognizing bone stability and appropriate occlusal load requirements.

Source page: https://510kreport.com/device/K073033
Methodology: https://510kreport.com/methodology