TAPERED SCREW-VENT IMPLANT, 4.1MM, MODELS: TSV4B8, B10, B11, B13 AND B16, TSV4H8, H11, H13 AND H16— 510(k) K072589

Substantially Equivalent

Zimmer Dental, Inc.

FDA 510(k) clearance K072589 for TAPERED SCREW-VENT IMPLANT, 4.1MM, MODELS: TSV4B8, B10, B11, B13 AND B16, TSV4H8, H11, H13 AND H16, Substantially Equivalent on 2007-10-04. Applicant: Zimmer Dental, Inc..

Clearance details

Applicant: Zimmer Dental, Inc.
Product code: Code DZE
Advisory panel: Dental
Date received: 2007-09-14
Decision date: 2007-10-04
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.