# K122664: Zuga Dental Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Zuga Medical, Inc.
- Decided: Apr 30, 2013 after 242 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: 11 generations back to K925765 (1993). 129 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 131 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043428: Reliadent Dental Implant System, Bioinfera, Inc. (2005) Summary page 1.
- K061323: Modification to Reliadent Dental Implant System, Bioinfera, Inc. (2007) Summary page 1.
- K100724: Osseotite II Model Xifossxxx, Biomet 3i, Inc. (2011) Summary page 1.
- K083544: Kat Implant System, Kat Implants, LLC (2009) Summary page 1.
- K101201: Straight Abutment, 4.2, 4.6, 5.0, 6.4, Implant 6.0, Implant 7.0, Implant 8.0 Model: 002061, 002062, 002063, 002064,, Kat Implants, LLC (2011) Summary page 1.
- K070841: Endosseous Dental Implant System, Southern Implants, Inc. (2007) Summary page 1.
- K071161: Endosseous Dental Implant System, Southern Implants, Inc. (2007) Summary page 1.

## Most influential descendants
- K171197: Zuga Dental Implant System (2018), 0 descendants of its own

## Indications for use
The Zuga Dental Implant System is indicated for immediate or delayed implant placement for surgical and restorative applications in maxillary and/or mandibular arches to support prosthetic devices, such as artificial teeth, crowns, bridges and overdentures. The Zuga Dental Implant System is indicated for immediate loading when good primary stability is achieved and with appropriate occlusal loading

Source page: https://510kreport.com/device/K122664
Methodology: https://510kreport.com/methodology