# K032774: Renova Internal Hex Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Lifecore Biomedical, Inc.
- Decided: Nov 26, 2003 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.
49 later devices descend from it; 6 cite it directly.
0 of 64 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013227: Screw Vent Implant; Tapered Screw Vent Implant, Sulzer Dental, Inc. (2001)
- K924589: Restore Self Tapping Dental Implant System, Implant Support Systems, Inc. (1994) Summary page 1.

## Most influential descendants
- K050506: Primasolo One-Piece Implants & Healing Caps (2005), 43 descendants of its own
- K051614: Primaconnex Internal Connection Implant System, Primaconnex Internal Connection Prosthetics (2005), 40 descendants of its own
- K101545: Genesis Implant System (2010), 15 descendants of its own
- K072241: Primaconnex Cad/Cam Abutment System (2007), 7 descendants of its own
- K062876: Primaconnex Ceramic Abutments (2006), 6 descendants of its own

## Indications for use
The Lifecore Biomedical RENOVA™ Internal Hex Implant System is 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/K032774
Methodology: https://510kreport.com/methodology