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

Name: FDA 510(k) clearance K102308
Creator: U.S. Food and Drug Administration
Published: 2010-11-22

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.. Device class: 2.

Clearance details

Applicant: Dentium Co., Ltd.
Product code: Code DZE
Device class: Class 2
Regulation: 21 CFR 872.3640
Advisory panel: Dental
Date received: 2010-08-16
Decision date: 2010-11-22
Decision: Substantially Equivalent
Clearance type: Special
Location: Cypress, CA, US

Download summary PDF View on FDA.gov ↗

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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.