K033198

Substantially Equivalent

APOZA ULTRASONIC SCALER AND EDODONTICS UNIT, SELECTOR U2

Applicant: Apoza Enterprise Co., Ltd.
Product code: ELC
Advisory panel: Dental
Date received: 2003-10-02
Decision date: 2004-04-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Taipei Hsien, TW

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.