ART-M1, MODEL M1-1-ART-A1— 510(k) K000510

Substantially Equivalent

Bonart Co., Ltd.

FDA 510(k) clearance K000510 for ART-M1, MODEL M1-1-ART-A1, Substantially Equivalent on 2000-05-15. Applicant: Bonart Co., Ltd..

Clearance details

Applicant: Bonart Co., Ltd.
Product code: Code ELC
Advisory panel: Dental
Date received: 2000-02-15
Decision date: 2000-05-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hsingchang, Taipei Hsien, 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.