APOZA ULTRASONIC SCALER AND EDODONTICS UNIT, SELECTOR U2— 510(k) K033198

Substantially Equivalent

Apoza Enterprise Co., Ltd.

FDA 510(k) clearance K033198 for APOZA ULTRASONIC SCALER AND EDODONTICS UNIT, SELECTOR U2, Substantially Equivalent on 2004-04-30. Applicant: Apoza Enterprise Co., Ltd..

Clearance details

Applicant: Apoza Enterprise Co., Ltd.
Product code: 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

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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.