ZIMMER 3.1MM DENTAL IMPLANT;2.9MM ANGLED ABUTMENT;STRAIGHT HEX, 2.9MM CONTOUR ABUTEMENT— 510(k) K142082

Substantially Equivalent

Zimmer Dental, Inc.

FDA 510(k) clearance K142082 for ZIMMER 3.1MM DENTAL IMPLANT;2.9MM ANGLED ABUTMENT;STRAIGHT HEX, 2.9MM CONTOUR ABUTEMENT, Substantially Equivalent on 2014-10-28. Applicant: Zimmer Dental, Inc..

Clearance details

Applicant: Zimmer Dental, Inc.
Product code: Code DZE
Advisory panel: Dental
Date received: 2014-07-31
Decision date: 2014-10-28
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.