Southern Implants MAX Implant System— 510(k) K191054

Substantially Equivalent

Southern Implants (Pty), Ltd.

FDA 510(k) clearance K191054 for Southern Implants MAX Implant System, Substantially Equivalent on 2019-12-09. Applicant: Southern Implants (Pty), Ltd..

Clearance details

Applicant: Southern Implants (Pty), Ltd.
Product code: Code DZE
Advisory panel: Dental
Date received: 2019-04-19
Decision date: 2019-12-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Guateng, ZA

Download summary PDF View on FDA.gov ↗

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.