Provata Implant System— 510(k) K222457

Name: FDA 510(k) clearance K222457
Creator: U.S. Food and Drug Administration
Published: 2023-03-06

Substantially Equivalent

Southern Implants (Pty), Ltd.

FDA 510(k) clearance K222457 for Provata Implant System, Substantially Equivalent on 2023-03-06. Applicant: Southern Implants (Pty), Ltd.. Device class: 2.

Clearance details

Applicant: Southern Implants (Pty), Ltd.
Product code: Code DZE
Device class: Class 2
Regulation: 21 CFR 872.3640
Advisory panel: Dental
Date received: 2022-08-15
Decision date: 2023-03-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Guateng, ZA

Download summary PDF View on FDA.gov ↗

Recent devices under product code DZE

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K260463 — ZEROS Dental Implant System2026-08-19
K251188 — UNIQA® Dental Implants System2026-06-25
K250806 — Dental Implant System2026-06-18
K251232 — MegaGen Zygoma Dental Implant System2026-06-18
K260006 — INOSS System2026-06-17

More clearances from Southern Implants (Pty), Ltd.

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K232726 — External Hex Implant System2024-04-01
K232418 — Single Platform SP1 Implant System2023-12-01
K230873 — Angulated Screw Channel (ASC) Solution Abutments & SI-BASE Abutments2023-08-01
K222469 — TIB Abutments2023-04-17
K222497 — Zaga Zygomatic System2022-11-09

Adverse events under product code DZE

product code DZE

Death: 28
Injury: 3,367,041
Malfunction: 19,958
Other: 13
Total: 3,387,040

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.