SIMPLELINE II MODEL SOFX483408R, SOFX483410R TOTAL 44 MODELS— 510(k) K102308

Substantially Equivalent

Dentium Co., Ltd.

FDA 510(k) clearance K102308 for SIMPLELINE II MODEL SOFX483408R, SOFX483410R TOTAL 44 MODELS, Substantially Equivalent on 2010-11-22. Applicant: Dentium Co., Ltd..

Clearance details

Applicant: Dentium Co., Ltd.
Product code: Code DZE
Advisory panel: Dental
Date received: 2010-08-16
Decision date: 2010-11-22
Decision: Substantially Equivalent
Clearance type: Special
Location: Cypress, 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.