ULTRASONIC SCALER— 510(k) K140233

Name: FDA 510(k) clearance K140233
Creator: U.S. Food and Drug Administration
Published: 2015-04-06

Substantially Equivalent

Nanning Baolai Medical Instrument Co., Ltd.

FDA 510(k) clearance K140233 for ULTRASONIC SCALER, Substantially Equivalent on 2015-04-06. Applicant: Nanning Baolai Medical Instrument Co., Ltd.. Device class: 2.

Clearance details

Applicant: Nanning Baolai Medical Instrument Co., Ltd.
Product code: Code ELC
Device class: Class 2
Regulation: 21 CFR 872.4850
Advisory panel: Dental
Date received: 2014-01-30
Decision date: 2015-04-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Guangzhou, Guangdong, CN

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.