Southern Implants PEEK Abutments— 510(k) K191250

Substantially Equivalent

Southern Implants (Pty), Ltd.

FDA 510(k) clearance K191250 for Southern Implants PEEK Abutments, Substantially Equivalent on 2019-12-05. Applicant: Southern Implants (Pty), Ltd..

Clearance details

Applicant: Southern Implants (Pty), Ltd.
Product code: Code NHA
Advisory panel: Dental
Date received: 2019-05-09
Decision date: 2019-12-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Guateng, ZA

Download summary PDF View on FDA.gov ↗

Adverse events under product code NHA

product code NHA

Injury: 1,270
Malfunction: 2,860
Total: 4,130

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.