PLAQ-ATAQ-I— 510(k) K980995

Substantially Equivalent

Ethicare

FDA 510(k) clearance K980995 for PLAQ-ATAQ-I, Substantially Equivalent on 1998-08-20. Applicant: Ethicare.

Clearance details

Applicant: Ethicare
Product code: Code EFW
Advisory panel: Dental
Date received: 1998-02-27
Decision date: 1998-08-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ft. Lauderdale, FL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code EFW

product code EFW

Injury: 143
Malfunction: 698
Total: 841

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.