ZIMMER ONE PIECE IMPLANT, 3.0MM ANGLED, MODELS ZOP30A10, ZOP30A11 AND ZOP30A13— 510(k) K071235

Substantially Equivalent

Zimmer Dental, Inc.

FDA 510(k) clearance K071235 for ZIMMER ONE PIECE IMPLANT, 3.0MM ANGLED, MODELS ZOP30A10, ZOP30A11 AND ZOP30A13, Substantially Equivalent on 2007-05-30. Applicant: Zimmer Dental, Inc..

Clearance details

Applicant: Zimmer Dental, Inc.
Product code: Code DZE
Advisory panel: Dental
Date received: 2007-05-03
Decision date: 2007-05-30
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.