TEMPORARY GINGIVAL CUFF AND IMPRESSION POST AND IMPLANT ANALOG— 510(k) K001786

Substantially Equivalent

Sulzer Calcitek, Inc.

FDA 510(k) clearance K001786 for TEMPORARY GINGIVAL CUFF AND IMPRESSION POST AND IMPLANT ANALOG, Substantially Equivalent on 2000-06-21. Applicant: Sulzer Calcitek, Inc..

Clearance details

Applicant: Sulzer Calcitek, Inc.
Product code: Code DZE
Advisory panel: Dental
Date received: 2000-06-13
Decision date: 2000-06-21
Decision: Substantially Equivalent
Clearance type: Special
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.