ULTRASONIC SCALER ELEGANCE MS-10 (25K)— 510(k) K040396

Substantially Equivalent

Rolence Enteprise, Inc.

FDA 510(k) clearance K040396 for ULTRASONIC SCALER ELEGANCE MS-10 (25K), Substantially Equivalent on 2004-04-22. Applicant: Rolence Enteprise, Inc..

Clearance details

Applicant: Rolence Enteprise, Inc.
Product code: Code ELC
Advisory panel: Dental
Date received: 2004-02-17
Decision date: 2004-04-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chungi, TW

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.