TSIR ANGLED ABUTMENTS— 510(k) K910585

Substantially Equivalent

Core-Vent Corp.

FDA 510(k) clearance K910585 for TSIR ANGLED ABUTMENTS, Substantially Equivalent on 1991-10-04. Applicant: Core-Vent Corp..

Clearance details

Applicant: Core-Vent Corp.
Product code: Code DZE
Advisory panel: Dental
Date received: 1991-02-11
Decision date: 1991-10-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Camarillo, 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.