K031421

Substantially Equivalent

ULTRASONIC SCALER, MODELS VARIOS 350 LUX, VARIOS 350 (NO LIGHT), VARIOS 550, VARIOS 150 LUX, VARIOS 150 (NO LIGHT)

Applicant: Nakanishi, Inc.
Product code: ELC
Advisory panel: Dental
Date received: 2003-05-05
Decision date: 2004-03-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Schaumburg, IL, US

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.