# K180465: Provata Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Southern Implants (Pty), Ltd.
- Decided: Sep 6, 2018 after 197 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: 14 generations back to K925765 (1993). 222 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 225 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K163634: External Hex Implants, Southern Implants (Pty), Ltd. (2017) Summary page 4.
- K040807: Mis Dental Implant System, Mis - Implant Technologies, Ltd. (2004) Summary page 4.
- K070905: Endosseous Dental Implant System, Southern Implants, Inc. (2007) Summary page 4.
- K053478: Endosseous Dental Implant System, Northern Implants, LLC (2006) Summary page 4.
- K163060: Deep Conical (DC) Implants and Accessories, Southern Implants (Pty), Ltd. (2017) Summary page 4.

## Most influential descendants
- K254145: Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™) (2026), 0 descendants of its own
- K222457: Provata Implant System (2023), 0 descendants of its own

## Indications for use
The Provata Implant System is intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment of crowns, bridges or overdentures utilizing delayed or immediate loading. The Provata Implant System is intended for immediate function when good primary stability with appropriate occlusal loading is achieved.

Source page: https://510kreport.com/device/K180465
Methodology: https://510kreport.com/methodology