SYNOCTA ANGLED ABUTMENTS FOR THE ITI WIDE NECK IMPLANT— 510(k) K013891

Substantially Equivalent

Institut Straumann AG

FDA 510(k) clearance K013891 for SYNOCTA ANGLED ABUTMENTS FOR THE ITI WIDE NECK IMPLANT, Substantially Equivalent on 2002-02-05. Applicant: Institut Straumann AG.

Clearance details

Applicant: Institut Straumann AG
Product code: Code DZE
Advisory panel: Dental
Date received: 2001-11-23
Decision date: 2002-02-05
Decision: Substantially Equivalent
Clearance type: Special
Location: Waltham, MA, 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.