KLOCKNER ESSENTIAL DENTAL IMPLANTS SYSTEM, MODELS ESSENTIAL CONE (EC), ESSENTIAL SOLID (ES) AND ECK— 510(k) K080224

Substantially Equivalent

SOADCO, S.L.

FDA 510(k) clearance K080224 for KLOCKNER ESSENTIAL DENTAL IMPLANTS SYSTEM, MODELS ESSENTIAL CONE (EC), ESSENTIAL SOLID (ES) AND ECK, Substantially Equivalent on 2008-07-03. Applicant: SOADCO, S.L..

Clearance details

Applicant: SOADCO, S.L.
Product code: Code DZE
Advisory panel: Dental
Date received: 2008-01-29
Decision date: 2008-07-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Escaldes-Engordany, AD

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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.