PIEZO TRONIC— 510(k) K982793

Name: FDA 510(k) clearance K982793
Creator: U.S. Food and Drug Administration
Published: 1998-10-28

Substantially Equivalent

Advanced Medical Devices, Inc.

FDA 510(k) clearance K982793 for PIEZO TRONIC, Substantially Equivalent on 1998-10-28. Applicant: Advanced Medical Devices, Inc.. Device class: 2.

Clearance details

Applicant: Advanced Medical Devices, Inc.
Product code: Code ELC
Device class: Class 2
Regulation: 21 CFR 872.4850
Advisory panel: Dental
Date received: 1998-08-10
Decision date: 1998-10-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

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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.