# K171197: Zuga Dental Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Zuga Medical, Inc.
- Decided: Jun 30, 2018 after 432 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: 12 generations back to K925765 (1993). 172 ancestors in all.
No later device cites it as a predicate yet.
0 of 173 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122664: Zuga Dental Implant System, Zuga Medical, Inc. (2013) Summary page 7.
- K152787: ST Internal Fixture System, T-Plus Implant Tech. Co., Ltd. (2016) Summary page 7.
- K090174: Tsi; Eri, Oco Biomedical (2009) Summary page 7.
- K072570: Nobelactive Multi Unit Abutment, Nobel Biocare AB (2007) Summary page 7.
- K043428: Reliadent Dental Implant System, Bioinfera, Inc. (2005) Summary page 7.
- K061323: Modification to Reliadent Dental Implant System, Bioinfera, Inc. (2007) Summary page 7.
- K100724: Osseotite II Model Xifossxxx, Biomet 3i, Inc. (2011) Summary page 7.
- K083544: Kat Implant System, Kat Implants, LLC (2009) Summary page 7.
- 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 7.
- K070841: Endosseous Dental Implant System, Southern Implants, Inc. (2007) Summary page 7.
- K071161: Endosseous Dental Implant System, Southern Implants, Inc. (2007) Summary page 7.
- K072878: Modification to: Locator Implant Anchor, Zest Anchors, Inc. (2007) Summary page 13.

## 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/K171197
Methodology: https://510kreport.com/methodology