SIMPLER TOADSTOOL ABUTMENT, MODEL S19000-S19009— 510(k) K093975

Substantially Equivalent

Pan Global Implant

FDA 510(k) clearance K093975 for SIMPLER TOADSTOOL ABUTMENT, MODEL S19000-S19009, Substantially Equivalent on 2010-06-04. Applicant: Pan Global Implant.

Clearance details

Applicant: Pan Global Implant
Product code: Code NHA
Advisory panel: Dental
Date received: 2009-12-24
Decision date: 2010-06-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Vancouver, CA

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.