HERO II DENTAL IMPLANT SYSTEM, UI DENTAL IMPLANT SYSTEM— 510(k) K130221

Substantially Equivalent

Medimecca Co., Ltd.

FDA 510(k) clearance K130221 for HERO II DENTAL IMPLANT SYSTEM, UI DENTAL IMPLANT SYSTEM, Substantially Equivalent on 2013-03-21. Applicant: Medimecca Co., Ltd..

Clearance details

Applicant: Medimecca Co., Ltd.
Product code: Code DZE
Advisory panel: Dental
Date received: 2013-01-29
Decision date: 2013-03-21
Decision: Substantially Equivalent
Clearance type: Special
Location: Anaheim, 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.