CLEANSE S+ ULTRASONIC SCALER— 510(k) K060171

Substantially Equivalent

Dmetec.Co., Ltd.

FDA 510(k) clearance K060171 for CLEANSE S+ ULTRASONIC SCALER, Substantially Equivalent on 2006-03-29. Applicant: Dmetec.Co., Ltd..

Clearance details

Applicant: Dmetec.Co., Ltd.
Product code: Code ELC
Advisory panel: Dental
Date received: 2006-01-23
Decision date: 2006-03-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Great Neck, NY, US

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.