# K110577: Osseofuse Dental Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Dynamic Innovations, Inc.
- Decided: Jul 14, 2011 after 135 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). 30 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032774: Renova Internal Hex Implant System, Lifecore Biomedical, Inc. (2003) Summary page 2.
- K071638: Biohorizons Tapered Internal Implant System, BioHorizons Implant Systems, Inc. (2007) Summary page 2.
- K061410: Screw-Vent Implant System, SV;Tapered Screw -Vent Implant System, TSV;Advent Implant System,AV;Zimmer One-Piece Implant, Zimmer Dental, Inc. (2006) Summary page 2.

## Most influential descendants
- K133050: One Plus Implant System (2014), 1 descendant of its own
- K151970: KJ Mini Implant System (2016), 0 descendants of its own
- K131748: Osseofuse Dental Implant System (2013), 0 descendants of its own
- K130221: Hero II Dental Implant System, UI Dental Implant System (2013), 0 descendants of its own

## Indications for use
The OsseoFuse Dental Implant System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. This system is dedicated for one and two stage surgical procedures and not dedicated for immediate loading. This system is intended for delayed loading.

Source page: https://510kreport.com/device/K110577
Methodology: https://510kreport.com/methodology