5.0MM SPLINE ENDOSSEOUS DENTAL IMPLANT SYSTEMS— 510(k) K955619

Substantially Equivalent

Calcitek, Inc.

FDA 510(k) clearance K955619 for 5.0MM SPLINE ENDOSSEOUS DENTAL IMPLANT SYSTEMS, Substantially Equivalent on 1996-03-08. Applicant: Calcitek, Inc..

Clearance details

Applicant: Calcitek, Inc.
Product code: Code DZE
Advisory panel: Dental
Date received: 1995-12-11
Decision date: 1996-03-08
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.