SICACE DENTAL IMPLANT SYSTEM AND SIC ANGLED ABUTMENTS— 510(k) K061500

Substantially Equivalent

Sic Invent AG

FDA 510(k) clearance K061500 for SICACE DENTAL IMPLANT SYSTEM AND SIC ANGLED ABUTMENTS, Substantially Equivalent on 2006-08-08. Applicant: Sic Invent AG.

Clearance details

Applicant: Sic Invent AG
Product code: Code DZE
Advisory panel: Dental
Date received: 2006-05-31
Decision date: 2006-08-08
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Mühlheim An Der Donau, DE

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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.