I-FIX SYSTEM— 510(k) K083586

Substantially Equivalent

Dentis Co., Ltd.

FDA 510(k) clearance K083586 for I-FIX SYSTEM, Substantially Equivalent on 2009-04-29. Applicant: Dentis Co., Ltd..

Clearance details

Applicant: Dentis Co., Ltd.
Product code: Code DZE
Advisory panel: Dental
Date received: 2008-12-04
Decision date: 2009-04-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Fe Springs, CA, US

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Adverse events under product code DZE

product code DZE

Death: 28
Injury: 3,367,041
Malfunction: 19,958
Other: 13
Total: 3,387,040

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.