COMPACT PIEZO P2K, POWERCARE— 510(k) K102218

Substantially Equivalent

Mectron S.P.A.

FDA 510(k) clearance K102218 for COMPACT PIEZO P2K, POWERCARE, Substantially Equivalent on 2011-01-24. Applicant: Mectron S.P.A..

Clearance details

Applicant: Mectron S.P.A.
Product code: Code ELC
Advisory panel: Dental
Date received: 2010-08-06
Decision date: 2011-01-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rome, IT

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.