3.75MM AND 5.0MM SPLINE TWIST IMPLANT— 510(k) K013494

Substantially Equivalent

Sulzer Dental, Inc.

FDA 510(k) clearance K013494 for 3.75MM AND 5.0MM SPLINE TWIST IMPLANT, Substantially Equivalent on 2002-01-18. Applicant: Sulzer Dental, Inc..

Clearance details

Applicant: Sulzer Dental, Inc.
Product code: Code DZE
Advisory panel: Dental
Date received: 2001-10-22
Decision date: 2002-01-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carlsbad, 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.