# K222457: Provata Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Southern Implants (Pty), Ltd.
- Decided: Mar 6, 2023 after 203 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: 15 generations back to K925765 (1993). 286 ancestors in all.
No later device cites it as a predicate yet.
0 of 287 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180282: MIS Internal Hex Dental Implant System, Mis Implants Technologies, Ltd. (2018) Summary page 5.
- K163634: External Hex Implants, Southern Implants (Pty), Ltd. (2017) Summary page 5.
- K180465: Provata Implant System, Southern Implants (Pty), Ltd. (2018) Summary page 5.
- K191250: Southern Implants PEEK Abutments, Southern Implants (Pty), Ltd. (2019) Summary page 5.
- K193084: TIB Abutment System, Southern Implants (Pty), Ltd. (2020) Summary page 5.

## Indications for use
Indications for Use for the Provata Implants: 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. The intended use for the 03.30 Provata implants is limited to replacement of maxillary and mandibular lateral and central incisors. The 12° angled Co-Axis Provata Implants are intended to only be used with straight abutments. Indications for Use for the TIB Abutments: The TIB Abutments are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation. The TIB abutments consist of two major parts. Specifically, the titanium base and mesostructure components make up a two-piece abutment. The system integrates multiple components of the digital dentistry workflow: Scan files from desktop scanners, CAD software, CAM software, ceramic material, milling machine and associated tooling and accessories. Indications for Use for the Conventional Abutments and Prosthetic Screws: The Conventional Abutments and Prosthetic Screws are premanufactured prosthetic components directly connected to endosseous dental implants and intended for use in fully edentulous or partially edentulous maxilla and/or mandible to provide support for crowns, bridges or overdentures. Indications for Use for the PEEK Temporary Abutments: The Southern Implants PEEK Abutments are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for provisional use up to 180 days as an aid in prosthetic rehabilitation. Indications for Use for the Temporary Titanium Abutments: The Southern Implants Temporary Titanium Abutments are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for provisional use up to 180 days as an aid in prosthetic rehabilitation.

Source page: https://510kreport.com/device/K222457
Methodology: https://510kreport.com/methodology