AMDENT 2030, POLISHER/SCALER— 510(k) K920328

Substantially Equivalent

Amdent AB

FDA 510(k) clearance K920328 for AMDENT 2030, POLISHER/SCALER, Substantially Equivalent on 1993-10-20. Applicant: Amdent AB.

Clearance details

Applicant: Amdent AB
Product code: Code ELC
Advisory panel: Dental
Date received: 1992-01-23
Decision date: 1993-10-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Nynashamn, SE

Download summary PDF View on FDA.gov ↗

Adverse events under product code ELC

product code ELC

Malfunction: 1,255
Total: 1,255

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.